Type 1 Diabetes
Conditions
Keywords
Health disparities, Family teamwork, Peer-delivered intervention, Facilitators to diabetes management, Barriers to diabetes management, Community-based intervention
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.
Interventions
BEHAVIORALFamily Teamwork-Peer Delivery
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability: Treatment Evaluation Inventory | Immediately post-intervention | Treatment Evaluation Inventory |
| Study Enrollment Rate | Pre-Randomization | Enrollment rate calculated from data obtained from recruitment logs |
| Study Attrition Rate | 12 months | Study attrition will be calculated from study 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Rate of Average Blood Glucose | Change from baseline at 12 months | Hemoglobin A1C from medical record |
| 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) |
| 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 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) |
Countries
United States
Outcome results
None listed