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Recruiting NCT06752369

Adapting Single Sessions Interventions for Type 1 Diabetes

No phase Interventional Type 1 Diabetes (T1D)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T1D-specific depression SSI, T1D Educational.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D). Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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.
  • Behavioral T1D Educational
    T1D Educational Material

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Problem Areas in Diabetes- Teen (PAID-T) [Time frame: 0, 3-months, and 6-months]
  • Diabetes Family Conflict Scale- Revised (DFCS-R) [Time frame: 0, 3-months, and 6-months]
  • Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen) [Time frame: 0, 3-months, 6-months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Nemours Children's Hospital - FL — Orlando

Identifiers

NCT: NCT06752369 · K23DK139431 · K23DK139431

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗