RecruitingNot ApplicableNCT06014879

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

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

Sponsor

Baylor College of Medicine

Enrollment

250 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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

Min Age: 10 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a strengths-based behavioral intervention (EMPoWER) for children aged 10–13 with Type 1 diabetes whose blood sugar control is not at target. The program focuses on building on personal strengths rather than focusing on problems, and involves both the child and their parent or guardian. **You may be eligible if...** - Your child is between 10 and 13 years old - Your child has had Type 1 diabetes for at least 6 months - Your child's most recent HbA1c (a 3-month average blood sugar measure) was 7.5% or higher - Your child is a patient at one of the participating study sites - You (the parent/guardian) are at least 18, fluent in English or Spanish, and have a phone with texting and internet access **You may NOT be eligible if...** - Your child has a serious medical condition (such as cancer or cystic fibrosis), a major psychiatric condition, or a developmental condition that would prevent full participation - You (the parent/guardian) have a serious medical or psychiatric condition that would prevent participation - Your family plans to move diabetes care out of the participating hospital within the next 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.