Family intervention for Black teens with type 1 diabetes
Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
This study is testing a new mobile health program to see if it can help Black teens with type 1 diabetes manage their blood sugar better and improve their family relationships.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 4 sites (Washington D.C., District of Columbia and 3 other locations) |
| Trial ID | NCT06275412 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of The 3Ms 2.0 intervention, delivered via mobile health technology, in improving glycemic control and family relationships among Black adolescents with type 1 diabetes and their primary caregivers. It is a multicenter, randomized controlled trial involving 216 adolescent-caregiver dyads, who will be assigned to either the intervention group or an educational control group. The intervention consists of three brief sessions aimed at enhancing parental supervision of diabetes management, while the control group receives general diabetes education. The trial is conducted at two sites, with Wayne State University overseeing the management.
Who should consider this trial
Good fit: Ideal candidates are Black adolescents aged 10 to 14 years diagnosed with type 1 diabetes for at least six months, along with their willing primary caregivers.
Not a fit: Patients with mental health conditions that could affect data integrity or those with co-morbid conditions affecting diabetes management may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved diabetes management and reduced caregiver distress for Black adolescents with type 1 diabetes.
How similar studies have performed: Other studies have shown promise in family-based interventions for diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 10 years, 0 months - 14 years, 11 months * Diagnosed with Type 1 diabetes * Diagnosed for at least 6 months * Black * Primary caregiver willing to participate * Residence within 30 miles of a recruitment site * Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc) Exclusion Criteria: * Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality) * Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis) * Inability to speak or read English * Child is in out-of-home placement
Where this trial is running
Washington D.C., District of Columbia and 3 other locations
- Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Wayne Pediatrics — Detroit, Michigan, United States (Recruiting)
- LeBonheur Children's Hospital — Memphis, Tennessee, United States (Recruiting)
- University of Tennessee Health Science Center-Memphis — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Deborah A Ellis, Ph.D. — Wayne State University
- Study coordinator: Deborah A Ellis, Ph.D.
- Email: dellis@med.wayne.edu
- Phone: 313-577-1055
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.