Feasibility Study of Family Teamwork Peer-Delivery

Study Overview
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Brief Summary
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The purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D. A randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists.

Official Title
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Feasibility Study of Family Teamwork Peer-Delivery

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Family Teamwork-Peer Delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary caregiver of a child ages 5-10 years with type 1 diabetes as defined by the American Diabetes Association criteria Having a child with diabetes duration of >1 year Self-identified African American or Latino race/ethnicity Fluent in English Not planning to leave the geographic area during the study Exclusion Criterion: • Not fluent in English

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Behavioral intervention delivered by parent peer leaders. | Behavioral: Family Teamwork-Peer Delivery<br>* Children with T1D and their parent will participate in 6 in-person FT-P group sessions during a 12-month period. Parents will also participate in monthly telephone support calls with a Parent Leader during the 12-month intervention period.<br>|
| No Intervention: Standard Care<br>Standard diabetes care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability: Treatment Evaluation Inventory | Treatment Evaluation Inventory | Immediately post-intervention | 
| Study Enrollment Rate | Enrollment rate calculated from data obtained from recruitment logs | Pre-Randomization | 
| Study Attrition Rate | Study attrition will be calculated from study logs | 12 months | 
| Monthly Intervention Calls Completed by Parent Leaders | Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rate of Average Blood Glucose | Hemoglobin A1C from medical record | Change from baseline at 12 months | 
| Change in Frequency of Adherence | Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire | Change from baseline at 12 months | 
| Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module | Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life) | Change from baseline at 12 months | 
| Change in Level of Parent involvement in diabetes management tasks | The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management) | Change from baseline at 12 months | 
| Change in Level of Parent self-efficacy | Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy) | Change from baseline at 12 months | 
| Change in Level of Parent diabetes emotional burden | Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden) | Change from baseline at 12 months | 
| Change in Level of Parent Depressive Symptoms | The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms) | Change from baseline at 12 months | 
| Change in Level of Parent Social Support | 2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support) | Change from baseline at 12 months | 
| Change in Degree of Impact of diabetes on the family system | Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family) | Change from baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health disparities, Family teamwork, Peer-delivered intervention, Facilitators to diabetes management, Barriers to diabetes management, Community-based intervention