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

Launched by ANN & ROBERT H LURIE CHILDREN'S HOSPITAL OF CHICAGO · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a program called Supporting Teen Problem Solving (STePS) that aims to help teenagers with Type 1 Diabetes manage their emotional distress related to their condition. The researchers want to see if STePS can effectively reduce feelings of distress and prevent worsening blood sugar control. They will compare two ways of delivering the program: in-person sessions at diabetes clinics and virtual sessions through telehealth. The study will involve 360 teenagers from diverse backgrounds across six locations in the United States.

To participate, teens need to have been diagnosed with Type 1 Diabetes for at least a year, use insulin, and be fluent in English. They also need to be able to use telehealth on a digital device. The trial includes nine sessions over four and a half months, with participants filling out surveys before, right after, and several months after the program. This study not only seeks to understand how effective the STePS program is but also how well it can be implemented in real-world settings, ensuring it can be offered widely to those who need it.

Gender

ALL

Eligibility 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.