Feasibility Study of Family Teamwork Peer-Delivery
- Conditions
- Type 1 Diabetes
- Interventions
- Behavioral: Family Teamwork-Peer Delivery
- Registration Number
- NCT04053504
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Family Teamwork-Peer Delivery Behavioral intervention delivered by parent peer leaders.
- Primary Outcome Measures
Name Time Method Intervention Acceptability: Treatment Evaluation Inventory Immediately post-intervention Treatment Evaluation Inventory
Study Attrition Rate 12 months Study attrition will be calculated from study logs
Study Enrollment Rate Pre-Randomization Enrollment rate calculated from data obtained from recruitment logs
Monthly Intervention Calls Completed by Parent Leaders 12 months Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs
- Secondary Outcome Measures
Name Time Method Change in Level of Parent diabetes emotional burden Change from baseline at 12 months Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden)
Change in Level of Parent Depressive Symptoms Change from baseline at 12 months The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms)
Change in Rate of Average Blood Glucose Change from baseline at 12 months Hemoglobin A1C from medical record
Change in Level of Parent self-efficacy Change from baseline at 12 months Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy)
Change in Frequency of Adherence Change from baseline at 12 months Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire
Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module Change from baseline at 12 months Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life)
Change in Level of Parent involvement in diabetes management tasks Change from baseline at 12 months The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management)
Change in Level of Parent Social Support Change from baseline at 12 months 2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support)
Change in Degree of Impact of diabetes on the family system Change from baseline at 12 months Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family)
Trial Locations
- Locations (1)
Texas Children's Hospital
🇺🇸Houston, Texas, United States