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Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02374138
Recruitment Status : Completed
First Posted : February 27, 2015
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Stephen J. Teach, MD, MPH, Children's National Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Behavioral: Parental stress management
Other: Usual Care
Enrollment 217
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Period Title: Six Month Follow Up
Started 110 107
Completed 102 [1] 93 [1]
Not Completed 8 14
[1]
6 Month Follow Up
Period Title: Twelve Month FollowUp
Started [1] 110 107
Completed 101 95
Not Completed 9 12
[1]
All participants were contacted at 12m, regardless of whether they completed the 6m interview.
Arm/Group Title Usual Care Intervention Total
Hide Arm/Group Description

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Total of all reporting groups
Overall Number of Baseline Participants 110 107 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 107 participants 217 participants
Parent Participants <=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
108
  98.2%
104
  97.2%
212
  97.7%
>=65 years
2
   1.8%
3
   2.8%
5
   2.3%
Child Participants <=18 years
110
 100.0%
107
 100.0%
217
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 107 participants 217 participants
Parent Participants 33.2  (8.9) 34.3  (10.0) 33.8  (9.5)
Child Participants 6.4  (2.3) 6.8  (2.3) 6.6  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 107 participants 217 participants
Parent Participants Female
100
  90.9%
100
  93.5%
200
  92.2%
Male
10
   9.1%
7
   6.5%
17
   7.8%
Child Participants Female
42
  38.2%
43
  40.2%
85
  39.2%
Male
68
  61.8%
64
  59.8%
132
  60.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants 107 participants 217 participants
110 107 217
1.Primary Outcome
Title Symptom-free Days in the Last 14 Days
Hide Description Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Time Frame Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with follow up available at each time period.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: days in prior 14d
11.4  (3.3) 11.6  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 6 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Asthma Morbidity - Nighttime Asthma Symptoms
Hide Description Nights of asthma symptoms in prior 14d
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at each follow up time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: days in prior 14d
Nighttime asthma symptoms at 6 Month FU Number Analyzed 102 participants 93 participants
1.7  (2.9) 1.9  (3.2)
Nighttime asthma symptoms at 12 Month FU Number Analyzed 101 participants 95 participants
2.1  (3.2) 1.5  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 6 month follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 12 month follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Asthma Severity and Control
Hide Description [Not Specified]
Time Frame Repeated Measures at 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Asthma Medication Adherence
Hide Description Reported use of inhaled corticosteroids and LTRA in past two days
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Follow Up Data Available at Each Time Point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
ICS use at 6 Month Follow Up Number Analyzed 102 participants 93 participants
68
  66.7%
68
  73.1%
ICS use at 12 Month Follow up Number Analyzed 101 participants 95 participants
55
  54.5%
61
  64.2%
LTRA use at 6 Month Follow Up Number Analyzed 102 participants 93 participants
14
  13.7%
16
  17.2%
LTRA use at 12 Month Follow Up Number Analyzed 101 participants 95 participants
20
  19.8%
18
  18.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments ICS Use at 6 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments ICS Use at 12 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments LTRA Use at 6 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments LTRA use at 12 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Health Care Utilization - Emergency Department Visits for Asthma
Hide Description Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere
Time Frame 12 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with follow up available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Error)
Unit of Measure: Visits
ED Visits between enrollment and 6m Follow Up Number Analyzed 102 participants 93 participants
0.32  (0.68) 0.32  (0.77)
ED Visits between 6m and 12m Follow up Number Analyzed 101 participants 95 participants
0.33  (0.65) 0.42  (0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments ED visits over 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments Adjusted for child age, gender, and baseline value
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments ED Visits between 6 and 12 Month follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Adjusted for child age, gender, and baseline value
Method Generalized Linear Model Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Asthma Exacerbations - Courses of Systemic Steroids
Hide Description Courses of systemic steroids over 12m follow up period
Time Frame Assessed at 6m and 12m following enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Error)
Unit of Measure: Courses of systemic steroids
Courses of systemic steroids over 6 Months Number Analyzed 102 participants 93 participants
0.30  (0.63) 0.29  (0.68)
Courses of systemic steroids btwn 6m and 12m FU Number Analyzed 101 participants 95 participants
0.26  (0.61) 0.30  (0.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Courses of systemic steroids over 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments Adjusted for child age, gender, and baseline value
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Courses of systemic steroids between 6m and 12m FU
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments Adjusted for child age, gender, and baseline value
Method Generalized Linear Model Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Parental Stress
Hide Description Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with follow up available at each time point.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
PSS Score at 6 Month Follow Up Number Analyzed 102 participants 93 participants
10.4  (7.3) 11.4  (7.1)
PSS Score at 12 Month Follow up Number Analyzed 101 participants 95 participants
10.3  (7.2) 12.6  (7.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 6 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 12 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Parental Depression
Hide Description Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants available at each follow up time point.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
CES-D 10 score at 6 Month Follow up Number Analyzed 102 participants 93 participants
6.8  (4.8) 7.4  (5.2)
CES-D 10 score at 12 Month Follow up Number Analyzed 101 participants 95 participants
7.6  (5.7) 8.0  (5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 6 Month follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 12 month follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments By repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Child Anxiety
Hide Description PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Score at 6 Month Follow up Number Analyzed 102 participants 93 participants
42.5  (9.6) 40.4  (7.8)
Score at 12 Month Follow Up Number Analyzed 101 participants 95 participants
43.1  (10.2) 41.5  (8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 6 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments At 12 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Child Depression
Hide Description PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Score at 6 Month Follow Up Number Analyzed 102 participants 93 participants
41.1  (7.7) 40.6  (7.0)
Score at 12 Month Follow Up Number Analyzed 101 participants 95 participants
42.3  (9.1) 41.2  (7.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments 6 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments 12 Month Follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Caregiver Quality of Life
Hide Description Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with follow up available at each time point. Note use of modified scale.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Score at 6 month Follow Up Number Analyzed 102 participants 93 participants
57.6  (8.8) 58.9  (8.1)
Score at 12 Month Follow Up Number Analyzed 101 participants 95 participants
58.1  (8.4) 57.8  (8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Quality of Life at 6 Month Follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Quality of Life at 12 Month Follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With AEs and SAEs
Hide Description Safety data: Number of Participants with AEs and SAEs
Time Frame 12m follow up period
Hide Outcome Measure Data
Hide Analysis Population Description
Participants available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
6 Month Follow Up Number Analyzed 102 participants 93 participants
0
   0.0%
0
   0.0%
12 Month Follow up Number Analyzed 101 participants 95 participants
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Economic Outcomes
Hide Description Analysis of costs of care in both groups
Time Frame 12m follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Caregiver Smoking Behavior
Hide Description parent report of cigarettes smoked per day
Time Frame Repeated Measures at 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
We are unable to analyze or report the data because it was not systematically collected.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Coping Strategies
Hide Description Brief COPE
Time Frame Repeated measures at 12m FU (6m data used for repeated measures)
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Hide Analysis Population Description
While we have collected this data, its analysis will be complex and require significant resources. We lack those resources at this time. We may at some point in the future return to this analysis.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Mindfulness
Hide Description Interpersonal Mindfulness in Parenting
Time Frame Repeated Measures at 6 and 12 months
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Hide Analysis Population Description
We are unable to analyze or report the data because it was not systematically collected.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Parental Resilience
Hide Description Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Time Frame Repeated Measures at 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with follow up available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Score on LOT-R at 6 Month Follow Up Number Analyzed 102 participants 93 participants
16.1  (3.3) 16.5  (4.5)
Score on LOT-R at 12 month Follow Up Number Analyzed 101 participants 95 participants
16.7  (3.3) 16.9  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Score on LOT-R at 6 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Score on LOT-R at 12 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Exacerbations - Hospital Admissions
Hide Description Number of participants with hospital admissions due to exacerbations
Time Frame Assessed at 6m and 12m after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at each time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
Pts hospitalized btwn enrollment and 6m FU Number Analyzed 102 participants 93 participants
5
   4.9%
4
   4.3%
Pts hospitalized btwn 6m and 12m FU Number Analyzed 101 participants 95 participants
7
   6.9%
9
   9.5%
19.Secondary Outcome
Title Symptom-free Days in the Last 14 Days
Hide Description Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Time Frame Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at 12m follow up
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 101 95
Mean (Standard Deviation)
Unit of Measure: days
10.9  (3.7) 11.8  (2.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments By repeated measures, p-value adjusted for age and gender
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments [Not Specified]
20.Secondary Outcome
Title Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Hide Description Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Time Frame Repeated measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at each follow up time point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: days in prior 14d
Daytime asthma symptoms at 6m FU Number Analyzed 102 participants 93 participants
1.64  (2.48) 1.83  (2.66)
Daytime asthma symptoms at 12m FU Number Analyzed 101 participants 95 participants
2.31  (3.24) 1.57  (2.39)
Days of activity limitation at 6m Number Analyzed 102 participants 93 participants
1.42  (2.53) 1.04  (1.74)
Days of activity limitation at 12m Number Analyzed 101 participants 95 participants
1.66  (2.99) 1.12  (2.31)
Days of quick relief medicine use at 6m Number Analyzed 102 participants 93 participants
2.75  (3.59) 2.96  (4.26)
Days of quick relief medicine use at 12m Number Analyzed 101 participants 95 participants
3.40  (4.16) 2.85  (3.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Daytime asthma symptoms in prior 14d at 6-month follow up
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments By repeated measures, p-value adjusted for age and gender
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Daytime Asthma Symptoms at 12 month follow up
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments By repeated measures, p-value adjusted for age and gender
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Days of Activity Limitations at 6 month follow up
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments By repeated measures, p-value adjusted for age and gender
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Days of Activity Limitations at 12 month follow up
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments By repeated measures, p-value adjusted for age and gender
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Days of Quick Relief Medicine Use at 6 month follow up
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments By repeated measures, p-value adjusted for age and gender
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Days of Quick Relief Medicine Use at 12 month follow up
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Generalized Linear Model Analysis
Comments By repeated measures, p-value adjusted for age and gender
21.Other Pre-specified Outcome
Title Sociodemographics
Hide Description Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
Parent Race : African American
110
 100.0%
107
 100.0%
Child Race : African American
110
 100.0%
107
 100.0%
Parent Ethnicity: Non-Hispanic
110
 100.0%
106
  99.1%
Child Ethnicity: Non-Hispanic
110
 100.0%
106
  99.1%
Public Insurance
110
 100.0%
107
 100.0%
Parent Education: Grade 1-11
9
   8.2%
19
  17.8%
Parent Education: GED or 12th grade
44
  40.0%
41
  38.3%
Parent Education: Some college/associates degree
39
  35.5%
33
  30.8%
Parent Education: College Graduate
18
  16.4%
14
  13.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Parent education
Type of Statistical Test Other
Comments Univariate test
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
22.Other Pre-specified Outcome
Title Number of Participants With Positive Smoke Exposure
Hide Description Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure.
Time Frame Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with follow up data available at each time point.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
6 Month Follow Up Number Analyzed 98 participants 89 participants
13
  13.3%
10
  11.2%
12 Month Follow up Number Analyzed 101 participants 95 participants
13
  12.9%
9
   9.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments ETS exposure at 6 Month Follow Up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments ETS Exposure at 12 Month Follow up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments Repeated measures, p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
23.Other Pre-specified Outcome
Title Parental Health Literacy
Hide Description Single Item Literacy Screener (SILS)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
Never needs assistance
98
  89.1%
95
  88.8%
Needs any assistance
12
  10.9%
12
  11.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Univariate test
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
24.Other Pre-specified Outcome
Title Use of Existing Ancillary Services
Hide Description [Not Specified]
Time Frame Assessed at 6m and 12m following enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at each follow up point
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Measure Type: Count of Participants
Unit of Measure: Participants
Parent use of mental health resources at 6 Months Number Analyzed 101 participants 89 participants
19
  18.8%
30
  33.7%
Parent use of mental health resources at 12 Months Number Analyzed 101 participants 95 participants
28
  27.7%
28
  29.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Parent use of mental health resources at 6 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments Parent use of mental health resources at 12 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments p-value adjusted for age and gender
Method Generalized Linear Model Analysis
Comments [Not Specified]
25.Other Pre-specified Outcome
Title Parental Resilience
Hide Description Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 110 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.1  (3.3) 16.2  (3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Univariate test
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
26.Other Pre-specified Outcome
Title Intervention Component Uptake
Hide Description Completion of intervention sessions
Time Frame 6 month intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Intervention group only
Arm/Group Title Intervention
Hide Arm/Group Description:

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
Completed 0 Intervention Sessions
8
   7.5%
Completed 1 Intervention Session
15
  14.0%
Completed 2 Intervention Sessions
4
   3.7%
Completed 3 Intervention Sessions
5
   4.7%
Completed 4 Intervention Sessions
75
  70.1%
27.Other Pre-specified Outcome
Title Intervention Satisfaction
Hide Description Brief survey of satisfaction with intervention components.
Time Frame 6 month intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available at 6 month follow up
Arm/Group Title Intervention
Hide Arm/Group Description:

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

Overall Number of Participants Analyzed 91
Measure Type: Count of Participants
Unit of Measure: Participants
"Very Much" satisfied with individual sessions
82
  90.1%
"Very Much" satisfied with delivery of sessions
86
  94.5%
28.Other Pre-specified Outcome
Title Intervention Fidelity
Hide Description Checklist of staff's fidelity to individual components of intervention protocol
Time Frame 6 month intervention period
Outcome Measure Data Not Reported
Time Frame For duration of trial (12 months following enrollment of each participant)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by “community wellness coaches.”

All-Cause Mortality
Usual Care Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/110 (0.00%)   0/107 (0.00%) 
Hide Serious Adverse Events
Usual Care Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/110 (0.00%)   0/107 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/110 (0.00%)   0/107 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen Teach, MD, MPH
Organization: Children's Research Institute
Phone: 202 476 5134
EMail: steach@childrensnational.org
Layout table for additonal information
Responsible Party: Stephen J. Teach, MD, MPH, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT02374138    
Other Study ID Numbers: 5819
First Submitted: February 10, 2015
First Posted: February 27, 2015
Results First Submitted: November 8, 2017
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019