Recruiting

Single-Session Intervention

Sponsor:

Nemours Children's Health System

Code:

NCT06752369

Conditions

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

T1D-specific depression SSI

T1D Educational

Study Details

Brief 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

Conditions

Type 1 Diabetes (T1D)

Study ID

NCT06752369

Start date

Aug 3, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

T1D Educational

T1D Educational Material

Primary outcome measure

  • Hemoglobin A1c (HbA1c) [ Time Frame: 0, 3-months, and 6-months ]
  • Patient Health Questionnaire for Adolescents (PHQ-9) [ Time Frame: 0, 3-months, and 6-months ]
  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: 7 days before and 7 days after SSI ]
  • Mood and Feelings Questionnaire (MFQ) [ Time Frame: 7 days before and 7 days after SSI ]
  • Feasibility of T1D-specific Depression SSI [ Time Frame: Baseline and 3-months ]
  • Acceptability of Healthcare Interventions Questionnaire [ Time Frame: immediately after SSI completion ]

Central Contacts and Locations

Central contacts

Alexandra Monzon, PhD

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

Locations

Nemours Children's Hospital - FL

Recruiting

Orlando, Florida, United States, 32827

Contacts

Alexandra Monzon, PhD

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

More Information

Sponsor

Nemours Children's Health System

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • type 1 diabetes
  • adolescents
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Health System on 2026-07-24.