Adapting Single Sessions Interventions for Type 1 Diabetes

Part of paid clinical trials in Orlando, Florida.

Sponsor
Nemours Children's Health System
Study ID
NCT06752369
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • T1D-specific depression SSI — BEHAVIORAL
    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.
  • T1D Educational — BEHAVIORAL
    T1D Educational Material

Study Details

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

Key Dates

Start date
Mar 2, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: T1D-specific depression SSI
    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.
  • Placebo Comparator: T1D Education
    Educational material about T1D

Primary Outcome Measure

Hemoglobin A1c (HbA1c) [ Time Frame: 0, 3-months, and 6-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's Hospital - FLOrlandoFlorida32827
Alexandra Monzon, PhD
[email protected]
904-603-6780

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By research site
Nemours Children's Hospital - FL· Orlando, FL

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