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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, and 12 months

Awards & highlights

EMPoWER Trial 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.Check my eligibility

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.See study design

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.

EMPoWER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am between 14 and 17 years old.

EMPoWER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Demographic and Medical Information Questionnaire

Glycemic Control - HbA1c

+2 more

Secondary outcome measures

Diabetes Distress

Diabetes Strength

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

+5 more

EMPoWER 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,882 Total Patients Enrolled

Children's National Research InstituteOTHER

211 Previous Clinical Trials

207,827 Total Patients Enrolled

Marisa Hilliard, PhDPrincipal InvestigatorBaylor College of Medicine

1 Previous Clinical Trials

120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what type of volunteers is this research endeavor open?

"To meet the requirements of this medical trial, applicants need to have type 1 diabetes and be in the age range of 14-17. Currently, there is space for roughly 30 individuals."

Answered by AI

Are people being enrolled in this experiment currently?

"This clinical trial, published on August 7th 2023 and last updated on August 22nd of the same year, is actively looking for patients."

Answered by AI

Is the research study recruiting geriatric participants?

"This clinical trial requires participants aged 14 to 17 and has 217 studies for minors. Additionally, 954 studies are available for patients who have exceeded 65 years of age."

Answered by AI

How many participants can be included in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment is currently searching for suitable participants with the initial post date of August 7th 2023 and latest update on August 22nd 2023. The research requires 30 individuals from a single clinic site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Marisa Hilliard 2023. "EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014879.

All > Type 1 Diabetes