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Behavioral Intervention for Type 1 Diabetes (EMPoWER Trial)

N/A

Recruiting

Led By Marisa Hilliard, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported type 1 diabetes diagnosis for ≥ 1 year

Age 14-17 at consent

Must not have

Major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis)

Major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is creating videos with preteens to help others with type 1 diabetes live healthier lives.

Who is the study for?

This trial is for English-speaking teens aged 14-17 living in the US with type 1 diabetes for at least a year. It's not suitable for those with major psychiatric or developmental disorders, or serious medical conditions like cancer or cystic fibrosis.

What is being tested?

The EMPoWER study is creating and testing teen-focused videos as part of a new behavioral intervention to help young people manage type 1 diabetes effectively alongside their parents.

What are the potential side effects?

Since this trial involves educational videos rather than medication, there are no direct medical side effects; however, participants may experience emotional responses to content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had type 1 diabetes for at least a year.

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I am between 14 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major health issues like cancer or cystic fibrosis.

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I do not have any major psychiatric or developmental disorders that would affect my ability to consent or participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence - Self-Care Inventory 2 (SCI-2)

Demographic and Medical Information Questionnaire

Glycemic Control - HbA1c

+2 more

Secondary study objectives

Diabetes Distress

Diabetes Strength

Family Conflict - Diabetes Family Conflict Scale - Revised (DFCS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Type 1 Doing Well (T1DW) ProgramExperimental Treatment1 Intervention

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.

Group II: Teen VideosExperimental Treatment1 Intervention

All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention.

Group III: Diabetes Care ProviderExperimental Treatment1 Intervention

Diabetes care providers will deliver the provider portion of the intervention and will also be enrolled as study participants.

Group IV: Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)Active Control1 Intervention

0 / 4Eligibility criteria met