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

Conditions

• Type 1 Diabetes

Eligibility Criteria

Sex

ALL

Age

10 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Type 1 Doing Well (T1DW) Program — BEHAVIORAL
  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.
• Diabetes-Related Information and Resources Program — OTHER
  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.

Study Details

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.

Key Dates

Start date

Oct 22, 2024

Status verified

Mar 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Demographic and Medical Information Questionnaire [ Time Frame: Baseline ]

Central Contacts

• Marisa Hilliard, PhD
  832-824-7209
  [email protected]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• Immune Function and the Progression to T1D
  Recruiting · University of Florida · Gainesville, Florida
• Registry for Stage 2 Type 1 Diabetes
  Recruiting · Sanofi · Baltimore, Maryland
• CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
  PHASE1/PHASE2 · Recruiting · COUR Pharmaceutical Development Company, Inc. · Tucson, Arizona
• Type 1 Diabetes Autonomic and Vascular Function
  Enrolling By Invitation · University of Texas at Austin · Austin, Texas