Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes
Baylor College of Medicine
Summary
The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.
Description
The goal of the randomized clinical trial (RCT) is to learn if a brief behavioral intervention targeting multiple systems ("Type 1 Doing Well" Program) can improve glycemic, behavioral, and psychosocial outcomes in youth with type 1 diabetes. Youth, age 10 to 13, will enroll with one parent or legal guardian to participate in the study with them. Researchers will compare the Type 1 Doing Well (T1DW) Program arm to the Enhanced Usual Care (EUC; "Diabetes-Related Information and Resources" Program) arm. Parent-youth dyads in both study arms will provide data (e.g. questionnaires, A1c, medical c…
Eligibility
- Age range
- 10–99 years
- Sex
- All
- Healthy volunteers
- No
For Trial Participants - Inclusion Criteria: Youth * type 1 diabetes diagnosis per ADA criteria for at least 6 months, * age 10 to 13 years at consent, * English or Spanish fluency, * At least one hemoglobin A1c value ≥ 7.5 % (percent) within the past 12 months (changed from ≥8.0% in March 2026) * Patient at one of the participating study sites Parent/legal guardian of youth * Age at least 18 years old at time of consent, * English or Spanish fluency, * Consistent access to a mobile phone that has texting capabilities and a device with internet access Exclusion Criteria: Youth Being tr…
Interventions
- BehavioralType 1 Doing Well (T1DW) Program
Parent and youth will each have access to a version of the app. The study app activities include parents and youth: * noticing what the youth does well for diabetes; * setting and tracking a family diabetes goal in the app; and * having a weekly meeting to review what the youth is doing well with diabetes and progress on the family diabetes goal. Parents and youth will also have access to age-appropriate libraries of videos with diabetes-specific content. Parents and youth will also have a conversation with the youth's diabetes care provider at a regularly scheduled diabetes appointment at participating hospital sites.
- OtherDiabetes-Related Information and Resources Program
Parent and youth will receive diabetes-related information and resources in the form of electronic handouts. They will receive one handout per month by email during the 6-month intervention period. These handouts include a variety of diabetes-related topics curated by the study team. Handouts will not include any specific information about the youth's health.
Location
- Baylor College of MedicineHouston, Texas