Print

Purpose

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

Condition

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
Placebo Comparator
T1D Education 		Educational material about T1D
  • Behavioral: T1D Educational
    T1D Educational Material

Recruiting Locations

Nemours Children's Hospital - FL
Orlando, Florida 32827
Contact:
Alexandra Monzon, PhD
904-603-6780
Alexandra.Monzon@nemours.org

More Details

Status
Recruiting
Sponsor
Nemours Children's Health System

Study Contact

Alexandra Monzon, PhD
904-603-6780
Alexandra.Monzon@nemours.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.