NCT06752369

Adapting Single Sessions Interventions for Type 1 Diabetes

Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nemours Children's Health System · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are: 1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement? 2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)? 3. Does a single-session depression intervention for youth with T1D lead to improvements in low mood? Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms. Participants will: * Participate in a single-session depression intervention * Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit * Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
BEHAVIORAL	T1D-specific depression SSI	The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.
BEHAVIORAL	T1D Educational	T1D Educational Material

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-08-01
• Completion: 2029-02-01
• First posted: 2024-12-30
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States