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
This study is testing a new online program to help kids aged 10 to 13 with type 1 diabetes and their parents improve their diabetes management and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 10 Years to 99 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06014879 on ClinicalTrials.gov |
What this trial studies
The EMPoWER Study is a randomized clinical trial aimed at improving glycemic, behavioral, and psychosocial outcomes in youth aged 10 to 13 with type 1 diabetes and their parents. Participants will be randomly assigned to either the Type 1 Doing Well (T1DW) Program, which utilizes a web-based mobile application to reinforce diabetes strengths, or to an Enhanced Usual Care program. Data will be collected at four timepoints, including questionnaires and medical data, to assess the impact of the intervention on glycemic control and health-related quality of life. The study seeks to engage both youth and their parents in a collaborative approach to diabetes management.
Who should consider this trial
Good fit: Ideal candidates are youth aged 10 to 13 with a diagnosis of type 1 diabetes for at least 6 months and at least one hemoglobin A1c value of 8% or higher.
Not a fit: Patients with major serious medical, psychological, or developmental conditions that interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved diabetes management and quality of life for youth with type 1 diabetes.
How similar studies have performed: Other studies have shown success with strengths-based approaches in chronic disease management, suggesting potential for positive outcomes in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
For Trial Participants - Inclusion Criteria: 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 ≥ 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 this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Marisa Hilliard, PhD — Baylor College of Medicine
- Study coordinator: Marisa Hilliard, PhD
- Email: marisa.hilliard@bcm.edu
- Phone: 832-824-7209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.