Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED)

Nemours Children's Health System

Status: Begins enrollment this month

Conditions: Type 1 Diabetes (T1D)

Treatments: Behavioral: T1D Educational; Behavioral: T1D-specific depression SSI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06752369

K23DK139431 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child or adolescent age between 11-18 years, inclusive
• Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
• Positive depression screening score of >5 on the PHQ-9 in the last year
• Not currently engaged in outpatient mental healthcare
• English fluency

Exclusion criteria

• Another systemic chronic medical illness except for celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
• Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups, including a placebo group

T1D-specific depression SSI

Experimental group

Description:

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.

Treatment:

Behavioral: T1D-specific depression SSI

T1D Education

Placebo Comparator group

Description:

Educational material about T1D

Treatment:

Behavioral: T1D Educational