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A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers

RecruitingNAAges 14 Years - 18 YearsAllJill Weissberg-Benchell, Ph.D.
NCT06709755 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators will assess both effectiveness (primary) and implementation (secondary) outcomes for a distress-reducing intervention, Supporting Teen Problem Solving (STePS). STePS has already undergone an efficacy trial. The current study allows for evaluating the outcomes of STePS by delivering it in real-world settings, using real-world providers. The investigators will train these behavioral health providers who are already embedded in diabetes clinics to use the STePS intervention. The investigators will also compare two approaches to intervention delivery: in-person versus telehealth. The investigators have recruited 6 different study sites across the country, representing diversity in rural vs. urban, public vs private insurance, as well as in ethnic and racial background of the participants. 360 teens will be enrolled and randomized to either STePS or an educational control gr

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📋 Eligibility rules (as published)
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.
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What it tests

  • Supporting Teen Problem Solving
  • Diabetes Education
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Where

1 site
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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