NCT06014879 · Baylor College of Medicine
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
(EMPoWER)
What this study is about
The EMPoWER Study randomly assigned clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 ≥ 7.5 % (percent) within the past 12 months (changed from ≥8.0% in March 2026)
- 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 criteria
- 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 Exclusion Criteria:
- major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation,
- major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis). Diabetes Care Provider Participants Inclusion Criteria: \- Provider at one of the sites' diabetes care centers
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations