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STEP: Social Support To Empower Parents (STEP)

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ClinicalTrials.gov Identifier: NCT00480493
Recruitment Status : Completed
First Posted : May 31, 2007
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Susan Sullivan-Bolyai, University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Type 1 Diabetes
Intervention Behavioral: STEP
Enrollment 60
Recruitment Details Mothers recruited from 2 pediatric diabetes clinics in NE US,randomized 1:1 to either E or C. Of 118 mothers approached, 30 declined due to hectic schedules or had enough support; 28 (24%) passive no. 60 mothers completed the consent and baseline data, randomized to either E (32) or C (28).
Pre-assignment Details  
Arm/Group Title Parent Mentor Contact Control Arm
Hide Arm/Group Description Parent mentor provides face-to-face, phone and/or e-mail social support Parent in this group receives parent contact phone number that they can call for parent support
Period Title: Overall Study
Started 32 28
Randomized 32 28
Completed 30 21
Not Completed 2 7
Reason Not Completed
moved             2             7
Arm/Group Title Parent Mentor Contact Control Arm Total
Hide Arm/Group Description Parent mentor provides face-to-face, phone and/or e-mail social support Parent in this group receives parent contact phone number that they can call for parent support Total of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
 100.0%
28
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
36  (6.5) 36  (6) 36  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
32
 100.0%
28
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 28 participants 60 participants
32 28 60
1.Primary Outcome
Title Maternal Confidence Scale
Hide Description Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with data were analyzed
Arm/Group Title Parent Contact Control Arm Parent Mentor Experimental Arm
Hide Arm/Group Description:
Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.
Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
Overall Number of Participants Analyzed 28 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
38  (7) 37  (10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Contact Control Arm, Parent Mentor Experimental Arm
Comments A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.46
Confidence Interval (2-Sided) 95%
-4.32 to 9.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.36
Estimation Comments Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.
2.Primary Outcome
Title Parent Concern
Hide Description Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Parent Contact Control Arm Parent Mentor Experimental Arm
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
149  (38) 154  (45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Contact Control Arm, Parent Mentor Experimental Arm
Comments A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.82
Confidence Interval (2-Sided) 95%
-15.47 to 25.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.05
Estimation Comments Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.
3.Primary Outcome
Title Worry
Hide Description Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Parent Contact Control Arm Parent Mentor Experimental Arm
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
27  (7) 27  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent Contact Control Arm, Parent Mentor Experimental Arm
Comments The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.48
Confidence Interval (2-Sided) 95%
-8.76 to 3.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.12
Estimation Comments We also used a random-effect, mixed regression models to look for between group changes over time.
Time Frame Adverse event data tracked for entire study (3 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Parent Mentor Contact Control Arm
Hide Arm/Group Description Parent mentor provides face-to-face, phone and/or e-mail social support Parent in this group receives parent contact phone number that they can call for parent support
All-Cause Mortality
Parent Mentor Contact Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Parent Mentor Contact Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Parent Mentor Contact Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/28 (0.00%) 
We did not have enough parents recruited to look at structural equation modeling.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Susan Sullivan-Bolyai
Organization: University of Massachusetts, Worcester
Phone: 508-856-4185
Responsible Party: Susan Sullivan-Bolyai, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00480493     History of Changes
Other Study ID Numbers: 1R15NR008391-01 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2007
First Posted: May 31, 2007
Results First Submitted: November 3, 2011
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012