Type 1 Diabetes (T1D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Nemours Children's Hospital - FL
RECRUITING
Orlando
Contact Information
Primary
Alexandra Monzon, PhD
Alexandra.Monzon@nemours.org
904-603-6780
Time Frame
Start Date: 2026-08-03
Estimated Completion Date: 2029-02
Participants
Target number of participants: 80
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Nemours Children's Health System

This content was sourced from clinicaltrials.gov

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