Status:
RECRUITING
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Children's National Research Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
10-99 years
Phase:
NA
Brief 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...
Detailed Description
The goal of the randomized clinical trial (RCT) is to learn if a brief behavioral intervention targeting multiple systems ("Type 1 Doing Well" Program) can improve glycemic, behavioral, and psychosoci...
Eligibility Criteria
Inclusion
- For Trial Participants -
- 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 ≥ 8 % (percent) within the past 12 months
- 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
- 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
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06014879
Start Date
October 22 2024
End Date
December 31 2027
Last Update
April 1 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030