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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Texas Children's Hospital
Houston, Texas, United States
Intervention Acceptability: Treatment Evaluation Inventory
Treatment Evaluation Inventory
Time frame: Immediately post-intervention
Study Enrollment Rate
Enrollment rate calculated from data obtained from recruitment logs
Time frame: Pre-Randomization
Study Attrition Rate
Study attrition will be calculated from study logs
Time frame: 12 months
Monthly Intervention Calls Completed by Parent Leaders
Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs
Time frame: 12 months
Change in Rate of Average Blood Glucose
Hemoglobin A1C from medical record
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline at 12 months
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