Single Session Intervention for Type 1 Diabetes

(ASSISTED Trial)

Overseen By Alexandra Monzon, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nemours Children's Health System

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for young people with Type 1 Diabetes (T1D), including those who may be experiencing low mood or depression. Participants should be willing to attend a single-session intervention, fill out questionnaires, and provide A1c samples over a period of six months.

Inclusion Criteria

I am between 11 and 18 years old.

I have been diagnosed with Type 1 Diabetes for at least 6 months.

Positive depression screening score of >5 on the PHQ-9 in the last year

Exclusion Criteria

Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.

I have a chronic illness, but it's not celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma.

Treatment Details

Interventions

• T1D-specific depression SSI (Behavioral Intervention)

Trial Overview The study tests if a one-time educational session focused on depression can improve the mood and health outcomes of youths with T1D. It compares this approach against regular diabetes education to see which is more effective in reducing depressive symptoms.

Participant Groups

Group I: T1D-specific depression SSI Experimental Treatment 1 Intervention

Single session depression intervention adapted for youth with T1D. 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.

Group II: T1D Education Placebo Group 1 Intervention

Educational material about T1D

Who Is Running the Clinical Trial?

Nemours Children's Health System

Lead Sponsor

Trials

11

Recruited

17,400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+