A Hybrid Effectiveness-implementation Trial of an Intervention to Reduce Diabetes-specific Emotional Distress in Teenagers

What this Trial Is About

This research aims to evaluate the effectiveness and implementation of Supporting Teen Problem Solving (STePS), an intervention designed to reduce diabetes-specific emotional distress in teenagers with Type 1 Diabetes Mellitus. The study includes 360 teens aged 14 to 18 from diverse backgrounds across six clinical sites. It compares STePS delivered in-person or via telehealth against an educational control group, focusing on improving emotional distress and preventing worsening blood sugar control over time. Participants are randomly assigned to one of three groups: STePS in-person, STePS via telehealth, or diabetes education via telehealth. Each group participates in a 4.5-month program consisting of nine sessions held twice monthly. STePS is a group-based behavioral intervention teaching emotion regulation and problem-solving skills to help teens manage diabetes-related distress. The study also examines how these delivery methods affect the uptake and sustainability of the intervention in real-world diabetes clinics. Throughout the study, participants complete surveys at the start, immediately after the intervention, and at 6 and 12 months post-intervention to measure diabetes distress and blood sugar control (Time in Range). Qualitative data from focus groups will explore participant and provider experiences. Researchers will assess recruitment, adherence, acceptability, costs, and program fidelity. The total participation spans about 16.5 months, including follow-up assessments to evaluate both clinical and practical outcomes of the intervention.

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