Reducing diabetes distress in teenagers
A Hybrid Effectiveness-implementation Trial of an Intervention to Reduce Diabetes-specific Emotional Distress in Teenagers
This study is testing a new program to help teenagers with Type 1 Diabetes feel less stressed about their condition by comparing in-person and online support sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 14 Years to 18 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06709755 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and implementation of the Supporting Teen Problem Solving (STePS) intervention aimed at reducing diabetes distress in adolescents with Type 1 Diabetes Mellitus. The intervention will be delivered by trained behavioral health providers in real-world settings, comparing in-person and telehealth approaches. A total of 360 teens will be enrolled and randomized to receive either the STePS intervention or an educational control group across six diverse study sites in the country.
Who should consider this trial
Good fit: Ideal candidates for this study are teenagers diagnosed with Type 1 Diabetes for at least one year, who are fluent in English and can provide consent.
Not a fit: Patients with cognitive or developmental disorders or those who are wards of the state may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the emotional well-being and diabetes management of teenagers with Type 1 Diabetes.
How similar studies have performed: Previous studies have shown promising results for similar interventions aimed at reducing diabetes distress in adolescents, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligibility criteria includes: * T1D diagnosis for at least 1-year, * using daily basal/bolus insulin, * fluent in English, * able to provide caregiver consent and teen assent to participate * able to access telehealth via a digital device. We will focus recruitment on participants from populations under-represented in diabetes research (e.g., racial and ethnic minorities, families of low SES, using public aid, or living in rural communities). Exclusion Criteria: To increase generalizability into typical clinical practice, exclusion criteria are minimal and include: * cognitive or developmental disorders, * participants cannot be a ward of the state.
Where this trial is running
Chicago, Illinois
- Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jill Weissberg-Benchell, Ph.D. — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Jill Weissberg-Benchell Professor, Ph.D.
- Email: jwbenchell@luriechildrens.org
- Phone: 312-227-3419
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.