Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ 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 ≥ 8 % (percent) within the past 12 months

• 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

• self-reported type 1 diabetes diagnosis for ≥ 1 year,

• age 14-17 at consent,

• English fluency,

• living in the United States

⁃ \- Provider at one of the sites' diabetes care centers

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Marisa Hilliard, PhD
marisa.hilliard@bcm.edu
832-824-7209
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 250
Treatments
Experimental: Type 1 Doing Well (T1DW) Program
Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the T1DW Program at the orientation session, parents and youth will receive an overview of the web-based mobile application and intervention activities that they will engage with for 6 months. The app-based intervention activities include brief daily use of the app for parents to recognize and reinforce their child's positive diabetes-related behaviors, brief weekly activities for parents and youth to reflect on and discuss what the child has done well for diabetes, family diabetes goal-setting, and videos for parents and youth about living well with T1D. Parents and youth will also engage in a brief strengths-based conversation with their diabetes care provider at one medical appointment during the study period.
Active_comparator: Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)
Youth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the EUC Program at the orientation session, parents and youth will receive monthly email handouts with diabetes-related information and resources for 6 months.
Related Therapeutic Areas
Sponsors
Collaborators: Children's National Research Institute
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov