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RECRUITING

NCT06014879

EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

10 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-10-22

Completion Date

2027-12-31

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Type 1 Diabetes

Interventions

BEHAVIORAL

Type 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.

OTHER

Diabetes-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.

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 treated for: * a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis), * a major serious psychological or psychiatric condition, * a major serious developmental condition that would interfere with capacity for informed assent or participation or that would confound outcomes Parents/legal guardian of youth participant Being treated for: * a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis), * a major serious psychological or psychiatric condition, * a major serious developmental condition that would interfere with capacity for informed consent or participation or that would confound outcomes Other Exclusion Criteria * Plans to move diabetes care out of participating hospital site within next 6 months, * Legal guardianship of the youth with diabetes being unclear at the time of screening or recruitment, * Study team learning of other involvement with the legal system during screening or recruitment For the Teen Videos: Inclusion Criteria: * self-reported type 1 diabetes diagnosis for ≥ 1 year, * age 14-17 at consent, * English fluency, * living in the United States Exclusion Criteria: * major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation, * major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis). Diabetes Care Provider Participants Inclusion Criteria: \- Provider at one of the sites' diabetes care centers

Locations (1)

Baylor College of Medicine

Houston, Texas, United States