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Study identifier: NCT06709755 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Type 1 Diabetes Mellitus  ·  Sponsor: Jill Weissberg-Benchell, Ph.D.

PhaseNA
Planned participants360
Who can joinAll sexes, 14 Years to 18 Years
Healthy volunteersNo

About this study

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 group on a 1:1:1 basis at each of our 6 study sites: STePS in-person (n=120), STePS telehealth (n=120), or educational control via telehealth (n=120). All 3 groups will be delivered as 4.5-month interventions, consisting of 9 sessions offered twice per month. Quantitative data (surveys) will be collected for all participants at baseline, immediately post-intervention, and 6 \& 12 months post-intervention. Qualitative data will also be collected post-intervention through focus groups. Aim 1. To test, in 360 teens across 6 clinical sites, the effectiveness of STePS in improving diabetes- specifi…

This description comes directly from the study's public registry record.

Talk to the study team

Jill Weissberg-Benchell Professor, Ph.D.  ·  312-227-3419  ·  jwbenchell@luriechildrens.org

Always discuss trial participation with your own doctor first.

Locations (1)

Ann and Robert H Lurie Childrens Hospital of ChicagoChicago, Illinois, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06709755