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Trial record 3 of 4 for:    1826329 [PUBMED-IDS]

The Pediatric Intermed: A New Clinical Decision Making Tool

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ClinicalTrials.gov Identifier: NCT01781481
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Janice S.Cohen, Children's Hospital of Eastern Ontario

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Inflammatory Bowel Disease
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
Period Title: Overall Study
Started 148
Completed 148
Not Completed 0
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Baseline Participants 148
Hide Baseline Analysis Population Description
Children and youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of Eastern ONtario with confirmed diagnoses of IBD (Crohn's disease or ulcererative colitis).
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 148 participants
14.00
(10.25 to 17.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
Female
59
  39.9%
Male
89
  60.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 148 participants
148
1.Primary Outcome
Title Pediatric INTERMED- Complexity Index
Hide Description

34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).

Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:

Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).

Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).

Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).

Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).

Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).

Time Frame Time of Study Participation (Completion of Pediatric INTERMED tool)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
Total Complexity Index
24
(8.25 to 39.75)
Pediatric INTERMED Biological Domain Score
9.0
(6 to 12)
Pediatric INTERMED Psychological Domain Score
4.0
(0 to 10)
Pediatric INTERMED Social Domain Score
4.0
(0 to 9)
Pediatric INTERMED Caregiver/Family Domain Score
4.0
(0 to 8.0)
Pediatric INTERMED Health Service Domain Score
3.0
(1.0 to 5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Inter-rater reliability
Estimated Value .87
Estimation Comments Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cronbach's Alpha
Estimated Value .91
Estimation Comments Overall internal consistency of the overall Pediatric INTERMED scale (34 items).
2.Primary Outcome
Title Correlations Between Pediatric INTERMED Domain Scores
Hide Description Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.
Time Frame Pediatric INTERMED scores at time of study participation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biological Psychological Social Family/Caregiver Health Service
Hide Arm/Group Description:
Sum of Biological Domain Item Scores
Sum of Psychological Domain Item Scores
Sum of Social Domain Item Scores
Sum of Family/Caregiver Domain Item Scores
Sum of Health Service Domain Item Scores
Overall Number of Participants Analyzed 148 148 148 148 148
Measure Type: Number
Unit of Measure: Correlation Coefficient
Biological 1 .29 .34 .32 .19
Psychological .29 1 .65 .64 .42
Social .34 .65 1 .63 .41
Caregiver/Family .32 .64 .63 1 .53
Health Service .19 .42 .41 .53 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Biological, Psychological
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p< .05.
Method Pearson Correlation Coefficients
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Biological, Social
Comments Correlation between the Biological and Social domain scores on the Pediatric INTERMED.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Biological, Family/Caregiver
Comments Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Biological, Health Service
Comments Correlation between Biological and Health Service Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Psychological, Social
Comments Correlation between Psychology and Social Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Psychological, Family/Caregiver
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Psychological, Health Service
Comments Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Social, Family/Caregiver
Comments Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Social, Health Service
Comments Correlation between Social and Health Service Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Family/Caregiver, Health Service
Comments Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
3.Primary Outcome
Title Pediatric INTERMED Items
Hide Description Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.
Time Frame Day 1 (At time of Pediatric Intermed Interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Score of 0 Score of 1 Score of 2 or 3
Hide Arm/Group Description:
Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item
Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.
Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
Overall Number of Participants Analyzed 148 148 148
Measure Type: Number
Unit of Measure: Percentage of participants
Biological: Chronicity .7 1.4 98
Biological: Diagnostic Dilemma .7 20.9 78.4
Biological: Symptom Severity 26.4 46.6 27
Biological: Diagnostic Challenge 60.8 20.9 18.2
Biological: Therapeutic Complexity 2.7 6.1 91.2
Biological: Complications and Life Threat 2.7 73.6 23.7
Psychological: Barriers to Coping 37.8 45.9 16.2
Psychological: Resiliency 43.9 43.2 12.8
Psychological: Mental Health History 51.4 30.4 18.2
Psychological: Cogntive/Intellectual Development 79.7 17.6 2.7
Psychological: Adverse Developmental Events 84.5 12.8 2.7
Psychological: Resistance to Treatment 49.3 41.9 8.8
Psychological: Mental Health Symptoms 36.5 53.4 10.2
Psychological: Cogntive/Functinonal Impairment 96.6 2.7 .7
Psychological: Mental Health/Cognitive Threat 31.8 58.1 10.1
Social: School Functionning 36.5 43.9 19.6
Social: Social Functioning 63.5 24.3 12.2
Social: Child/Youth Supports 77.7 21.6 .7
Social: School Attendance 55.4 25 19.6
Social: Educational NEeds 54.1 27.7 18.3
Social: Community Participation 61.5 28.4 10.2
Social System Vulnerability 37.8 52 10.2
Family: Family Relationships 58.8 33.1 8.1
Family: Caregiver Health/Function 45.3 43.9 10.8
Family: Residential Stability 60.1 33.8 6.1
Family: Caregiver/Family Support 61.5 25.7 12.8
Family: Family Stress 14.9 66.9 18.2
Family: Parental Skills 62.8 34.5 2.7
Family/Caregiver System Vulnerability 39.2 55.4 5.4
Health System: Access to Health Care 57.4 38.5 4.1
Health System: Treatment Experience 51.4 43.2 5.4
Health System: Organization of Care 2 81.1 16.9
Health System: Coordination of Care 70.9 25 4.1
Health System Impediments 34.5 61.5 4.1
4.Primary Outcome
Title IBD Disease Severity
Hide Description IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disease Severity: Remission/Inactive Disease Severity: Mild Disease Severity: Moderate Disease Severity: Severe
Hide Arm/Group Description:
Disease Severity classified as in remission/inactive
Disease Severity classified as mild
Disease Severity classified as moderate
Disease Severity classified as severe
Overall Number of Participants Analyzed 148 148 148 148
Measure Type: Number
Unit of Measure: percentage of participants
Disease Severity at Pediatric INTERMED Interview 62.8 25.7 8.1 3.4
Disease Severity at Diagnosis 4.3 25.7 32.1 37.9
5.Primary Outcome
Title Time Since IBD Diagnosis
Hide Description Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.
Time Frame Data collected through chart review at time of Pediatric INTERMED interview.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Less Than 6 Months 6 Months-1 Year 1 Year-5 Years Greater Than 5 Years
Hide Arm/Group Description:
Less than 6 months since initial IBD diagnosis.
6 months to 1 year since initial IBD diagnosis.
1 - 5 years since initial IBD diagnosis.
Greater than 5 years since initial IBD diagnosis.
Overall Number of Participants Analyzed 148 148 148 148
Measure Type: Number
Unit of Measure: Percentage of Participants
15.5 34.5 32.4 17.6
6.Primary Outcome
Title Disease Course and Treatment
Hide Description Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).
Time Frame Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Full Range)
Unit of Measure: number of times it occurred
Number of Hospitalizations since Diagnosis
1
(0 to 11)
Number of Surgeries Since Diagnosis
0
(0 to 4)
Number of Courses of Prednisone
1
(0 to 5)
7.Primary Outcome
Title IBD Treatment With Immunomodulators or Anti-TNFa Medications
Hide Description Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).
Time Frame Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: Percentage of participants treated
Use of Immunomodulators 55.4
Use of anti-TNFa Medications 42.6
8.Primary Outcome
Title Functional Disability Inventory
Hide Description Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991).
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 145
Median (Full Range)
Unit of Measure: units on a scale
FDI - Child Report
4
(0 to 45)
FDI- Parent Report
2
(0 to 44)
9.Primary Outcome
Title Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.
Hide Description 35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).
Time Frame Day 1 (At time of Pediatric Intermed Interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 142
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Impact III: Emotional Functioning
45
(35.75 to 54.25)
Impact III: Social Interactions
22
(18 to 26)
Impact III: General Well-Being
57
(43.50 to 70.50)
10.Primary Outcome
Title Child Behaviour Checklist
Hide Description Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 136
Median (Inter-Quartile Range)
Unit of Measure: Units on a Scale - T Scores
CBCL Internalizing
54
(39 to 69)
CBCL Externalizing
46
(32 to 50)
CBCL Social Competence
45
(34.50 to 55.50)
CBCL Activities Competence
48
(34 to 62)
CBCL Academic Competence
50
(38.5 to 51.5)
11.Primary Outcome
Title Children's Depression Inventory
Hide Description 27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.
Time Frame Administered at study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 143
Median (Inter-Quartile Range)
Unit of Measure: Units on a Scale - T Scores
42
(34 to 50)
12.Primary Outcome
Title Multidimensional Anxiety Scale for Children
Hide Description Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.
Arm/Group Title Children/Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 145
Median (Inter-Quartile Range)
Unit of Measure: units on a scale- T scores
50.00
(36.50 to 63.50)
13.Primary Outcome
Title Pediatric Inventory for Parents- Difficulty Score
Hide Description Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 133
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
82
(42.5 to 121.5)
14.Primary Outcome
Title Family Inventory of Life Events and Changes
Hide Description Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 139
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
7
(0 to 14)
15.Primary Outcome
Title Family Inventory of Resources for Management
Hide Description Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.
Time Frame Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 133
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Firm: Total Score
127
(99 to 155)
FIRM: Financial Well-being Scale
36
(24.50 to 37.50)
16.Primary Outcome
Title Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning
Hide Description Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.
Time Frame Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric INTERMED Biological Domain Score Historical Biological Item: Chronicity Historical Biological Item: Diagnostic Dilemma Current Biological Item: Symptom Severity Current Biological Item: Diagnostic/Therapeutic Challenge Current Biological Item: Therapeutic Complexity Vulnerability Biological Item: Complications and Life Threat
Hide Arm/Group Description:
Sum of all Pediatric INTERMED Biological domain item scores.
This item taps the extent and chronicity of child's physical health issues.
This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.
This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.
This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.
This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.
This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Overall Number of Participants Analyzed 148 148 148 148 148 148 148
Measure Type: Number
Unit of Measure: Correlation Coefficients
Disease Severity at Diagnosis -.06 .06 -.12 .09 -.15 .04 -.02
Disease Severity at Study Enrolment .36 .01 -.08 .53 .20 .17 .18
Functional Disability Index- Child Rating .50 .16 .00 .56 .20 .03 .23
Functional Disability Index - Parent Rating .52 .27 -.10 .51 .14 .09 .27
Impact III: General Well-Being Scale -.45 -.05 .03 -.65 -.24 -.01 -.17
Number of Surgeries since Diagnosis .00 .10 .15 .02 .09 -.14 .13
Number of Courses of Prednisone since Diagnosis .10 .08 .06 -.01 -.10 .18 -.07
Use of Chemical Immunomodulators since Diagnosis -.11 -.18 -.11 .16 .07 -.42 -.20
Use of Biological Immunodulators Since Diagnosis -.09 .13 -.04 -.09 .12 -.32 -.06
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p< .05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Biological Domain Score
Comments Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p< 0.05.
Method Spearman Correlation Coefficent
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Chronicity
Comments Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Disease Severity at Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and IBD Disease Severity at time of study participation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and Functional Disability Index (child rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and Functional Disability Index (Parent Rating)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and Impact Quality of Life: General Well-Being Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Number of Surgeries
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Number of Courses of Prednisone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Use of Immunomodulators.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Symptom Severity
Comments Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Use of anti-TNFa Medications.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Historical Biological Item: Diagnostic Dilemma
Comments Correlations between Pediatric INTERMED "Diagnostic Dilemma" Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05. The P-Value indicated above was found for all the correlations which were examined.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and IBD Disease Severity at Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and IBD Disease Severity at time of study participation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Functional Disability Index (Child Rating)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Functional Disability Index (parent rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Number of Surgeries.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Number of Courses of Prednisone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Use of Immunomodulators. .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Diagnostic/Therapeutic Challenge
Comments Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Use of anti-TNFa Medications
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Disease Severity at Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Functional Disability Index (Child Rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Functional Disability Index (Parent Rating)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Impact Quality of Life: General Well-Being
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Number of Surgeries.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Number of Courses of Prednisone since diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significiance is p<0.01.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Current Biological Item: Therapeutic Complexity
Comments Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The Threshold for significance is p<0.05)
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Disease Severity at diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Disease Severity at study participation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Functional Disability Index (Child Rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Functional Disability Index (parent rating).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.01.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Number of Surgeries.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Number of Courses of Prednisone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Vulnerability Biological Item: Complications and Life Threat
Comments Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Use of anti-TNFa Medications.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
17.Primary Outcome
Title Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.
Hide Description Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).
Time Frame Day 1 (Time of Study Participation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric INTERMED Psychological Domain Score Pediatric INTERMED Social Domain Score Pediatric INTERMED Caregiver/Family Domain Score
Hide Arm/Group Description:
Sum of Pediatric INTERMED Psychological Domain item scores
Sum of Pediatric INTERMED Social Domain items scores
Sum of Pediatric INTERMED Caregiver/Family Domain item scores
Overall Number of Participants Analyzed 133 133 133
Measure Type: Number
Unit of Measure: Pearson Correlation Coefficient
CBCL Internalizing Score .56 .46 .46
CBCL Externalizing Score .52 .42 .38
Children's Depression Inventory .41 .46 .38
Multidimensional Anxiety Scale for Children .24 .19 .14
Impact III: Emotional Functioning -.35 -.30 -.33
CBCL Social Competence -.32 -.38 -.29
CBCL Activities Competence -.18 -.23 -.27
CBCL Academic Competence -.50 -.59 -.35
Impact III: Social Interactions .40 -.38 -.37
PIP Difficulty Score .22 .41 .39
Family Inventory of Life Events .31 .36 .41
Family Inventory of Resources for Management -.26 -.28 -.46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Psychological Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Social Domain Score
Comments Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Pediatric INTERMED Caregiver/Family Domain Score
Comments Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
18.Primary Outcome
Title Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.
Hide Description This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.
Time Frame Day 1 (At time of Pediatric Intermed Interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.
Arm/Group Title Subjects With MASC Scores in the Clinical Range. Subjects With MASC Scores in the Non-clinical Range
Hide Arm/Group Description:
Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.
Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
Overall Number of Participants Analyzed 145 145
Measure Type: Number
Unit of Measure: participants
Mental Health/Cognitive Vulnerability Need 4 10
No Mental Health/Cognitive Vulnerability 6 125
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subjects With MASC Scores in the Clinical Range., Subjects With MASC Scores in the Non-clinical Range
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
2.02 to 34.47
Estimation Comments [Not Specified]
19.Primary Outcome
Title Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.
Hide Description This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.
Time Frame Day 1 (At time of Pediatric Intermed Interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.
Arm/Group Title Subjects With CDI Scores in the Clinical Range. Subjects With CDI Scores in the Non-clinical Range
Hide Arm/Group Description:
Children whose scores on the Children's Depression Inventory fell within the clinical range.
Children whose scores on the Children's Depression Inventory fell below the clinical range.
Overall Number of Participants Analyzed 143 143
Measure Type: Number
Unit of Measure: participants
Mental Health/Cognitive Vulnerability Need 3 11
No Mental Health/Cognitive Vulnerability 4 125
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subjects With CDI Scores in the Clinical Range., Subjects With CDI Scores in the Non-clinical Range
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.52
Confidence Interval (2-Sided) 95%
1.70 to 43.02
Estimation Comments [Not Specified]
20.Primary Outcome
Title Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.
Hide Description This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.
Time Frame Day 1 (At time of Pediatric Intermed Interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.
Arm/Group Title CBCL Internalizing Score in the Clinical Range. CBCL Internalizing Score in the Non-clinical Range
Hide Arm/Group Description:
Children whose scores on the CBCL Internalizing Scale fell within the clinical range.
Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
Overall Number of Participants Analyzed 135 135
Measure Type: Number
Unit of Measure: participants
Mental Health/Cognitive Vulnerability Need 8 5
No Mental Health/Cognitive Vulnerability 22 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CBCL Internalizing Score in the Clinical Range., CBCL Internalizing Score in the Non-clinical Range
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.27
Confidence Interval (2-Sided) 95%
2.17 to 24.36
Estimation Comments [Not Specified]
21.Primary Outcome
Title Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.
Hide Description This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.
Time Frame Day 1 (At time of Pediatric Intermed Interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.
Arm/Group Title CBCL Externalizing Score in the Clinical Range. CBCL Externalizing Score in the Non-clinical Range
Hide Arm/Group Description:
Children whose scores on the CBCL Externalizing scale fell within the clinical range.
Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
Overall Number of Participants Analyzed 135 135
Measure Type: Number
Unit of Measure: participants
Mental Health/Cognitive Vulnerability Need 5 8
No Mental Health/Cognitive Vulnerability 3 119
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CBCL Externalizing Score in the Clinical Range., CBCL Externalizing Score in the Non-clinical Range
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 24.79
Confidence Interval (2-Sided) 95%
5.00 to 122.84
Estimation Comments [Not Specified]
22.Primary Outcome
Title Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators
Hide Description Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.
Time Frame Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Intermed: Health System Domain Score Historical Health System Item: Access to Health Care Historical Health System Item: Treatment Experience Current Health System Item: Organization of Care Current Health System Item: Coordination of Care Vulnerability Health System Item: Health System Impediments
Hide Arm/Group Description:
Sum of Pediatric INTERMED health system item scores.
This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.
This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.
This item describes the nature and organization of the health care services that the child is current receiving.
This item describes the extent to which the different health care providers working with the child are in contact with each other.
This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
Overall Number of Participants Analyzed 148 148 148 148 148 148
Measure Type: Number
Unit of Measure: Correlation Coefficients
Number of Services involved in Child's Care .26 .08 .25 .37 .20 .15
Number of Hospitalizations since Diagnosis .34 .36 .14 .11 .09 .23
Numbers of Surgeries since Hospitalization .22 .25 .10 .08 .13 .11
FIRM: Financial Well Being Scale -.32 -.34 -.13 -.03 -.15 -.36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pediatric Intermed: Health System Domain Score
Comments Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pediatric Intermed: Health System Domain Score
Comments Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pediatric Intermed: Health System Domain Score
Comments Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pediatric Intermed: Health System Domain Score
Comments Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Pearson Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Access to Health Care
Comments Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Number of Hospital Services Involved in the Child's Care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Access to Health Care
Comments Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Access to Health Care
Comments Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Number of Surgeries since Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Access to Health Care
Comments Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Family Financial Well-Being.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Treatment Experience
Comments Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Number of Hospital Services Involved in the Child's Care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Treatment Experience
Comments Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Treatment Experience
Comments Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Number of Surgeries since child's diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Historical Health System Item: Treatment Experience
Comments Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Family Financial Well-Being.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Organization of Care
Comments Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Number of Hospital Services Involved in the Child's Care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Organization of Care
Comments Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Number of Hospitalizations since IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Organization of Care
Comments Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Organization of Care
Comments Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Family Financial Well-Being.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Coordination of Care
Comments Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Number of Hospital Services Involved in the Child's Care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Coordination of Care
Comments Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Coordination of Care
Comments Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Number of Surgeries Child's IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Current Health System Item: Coordination of Care
Comments Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Family Financial Well Being.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vulnerability Health System Item: Health System Impediments
Comments Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vulnerability Health System Item: Health System Impediments
Comments Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vulnerability Health System Item: Health System Impediments
Comments Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vulnerability Health System Item: Health System Impediments
Comments Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Family Financial Well-Being.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance is p<0.05.
Method Spearman Correlation Coefficient
Comments [Not Specified]
23.Primary Outcome
Title Total Number of Hospital Services Involved in Child's Care.
Hide Description Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.
Time Frame Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Full Range)
Unit of Measure: R Square change statistic
2.00
(0 to 5.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p<0.05 Threshold for statistical significance
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Rsquare change statistic
Estimated Value 0.08
Estimation Comments [Not Specified]
24.Primary Outcome
Title Number of Calls to IBD Nurse
Hide Description Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview
Time Frame Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Full Range)
Unit of Measure: Number of calls
0
(0 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Threshold for statistical significance is p<0.01
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter R2Change
Estimated Value .05
Estimation Comments [Not Specified]
25.Primary Outcome
Title Number of Extra Appointments With the IBD Team
Hide Description Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.
Time Frame Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Full Range)
Unit of Measure: Number of appointments
0
(0 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments p<.05 threshold for statistical significance
Method Regression, Linear
Comments Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
Method of Estimation Estimation Parameter Rsquare change statistic
Estimated Value .05
Estimation Comments [Not Specified]
26.Primary Outcome
Title Number of Visits to the Hospital Emergency Department
Hide Description Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.
Time Frame Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Full Range)
Unit of Measure: Emergency Department Visits
0
(0 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Threshold for statistical significance is p <0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter R2Change
Estimated Value .03
Estimation Comments [Not Specified]
27.Primary Outcome
Title Number of Inpatient Hospital Admissions
Hide Description Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.
Time Frame Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description:
Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Number of Participants Analyzed 148
Median (Full Range)
Unit of Measure: Number of hospital admissions
0
(0 to 3.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children and Youth With IBD
Comments A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter R2Change
Estimated Value .07
Estimation Comments [Not Specified]
Time Frame At time of study participation and for 6 months following this.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Children and Youth With IBD
Hide Arm/Group Description Children/youth (ages 8-17) with confirmed diagnoses of IBD.
All-Cause Mortality
Children and Youth With IBD
Affected / at Risk (%)
Total