Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED)

January 13, 2026 updated by: Alexandra Monzon, Nemours Children's Health System

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: 0, 3-months, and 6-months
Proxy measure of glycemic level. HbA1c is the average blood glucose level over 3-4 months. We will use fingerstick blood samples and a valid mail-in dried blood spot kit to measure participant HbA1c levels at a central laboratory
0, 3-months, and 6-months
Patient Health Questionnaire for Adolescents (PHQ-9)
Time Frame: 0, 3-months, and 6-months
The PHQ-9 is a well-validated and reliable measure that assesses the occurrence of nine possible depressive symptoms over the previous two weeks. Higher scores indicate greater depressive symptoms. A cut-off score of >5 will be used to characterize elevated depressive symptoms
0, 3-months, and 6-months
Positive and Negative Affect Schedule (PANAS)
Time Frame: 7 days before and 7 days after SSI
The PANAS is a 20-item measure that assesses different feelings and emotions. Items are grouped into the two subscales with 10 items each: positive affect and negative affect, with higher scores on the Positive Affect subscale indicating greater intensity of positive emotions, and higher scores on the Negative Affect subscale indicating greater intensity of negative emotions.
7 days before and 7 days after SSI
Mood and Feelings Questionnaire (MFQ)
Time Frame: 7 days before and 7 days after SSI
The MFQ is a 13-item measure that assesses depressed mood in youth. Higher scores indicate higher depressed mood.
7 days before and 7 days after SSI
Feasibility of T1D-specific Depression SSI
Time Frame: Baseline and 3-months
We will determine feasibility by calculating study enrollment rates for the Aim 2 pilot trial. We will also assess the feasibility of the type 1 diabetes (T1D)-specific depression single-session intervention (SSI) in the qualitative interviews
Baseline and 3-months
Acceptability of Healthcare Interventions Questionnaire
Time Frame: immediately after SSI completion

The Acceptability of Healthcare Interventions Questionnaire is an 8-item measure that assesses the acceptability of healthcare interventions. Respondents rate each question on a scale of

1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater intervention acceptability.
immediately after SSI completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problem Areas in Diabetes- Teen (PAID-T)
Time Frame: 0, 3-months, and 6-months
The PAID-T is a 26-item measure that assesses diabetes-specific emotional distress in adolescents with T1D. Adolescents rate how much each item applies to them on a 6-point Likert scale from 1 (Not a Problem) to 6 (Serious Problem), with higher scores indicating greater distress.
0, 3-months, and 6-months
Diabetes Family Conflict Scale- Revised (DFCS-R)
Time Frame: 0, 3-months, and 6-months
The DFCS-R is a 19-item measure that evaluates conflict between youth and their caregivers surrounding direct and indirect diabetes management tasks. Adolescents will rate how often they argue with their parents on a 3-point Likert scale ranging from 1 (Never Argue) to 3 (Always Argue), with higher scores indicating more parent-child conflict.
0, 3-months, and 6-months
Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)
Time Frame: 0, 3-months, 6-months
The DSTAR-teen is a 12-item measure that assesses adaptive behaviors and attitudes about diabetes in adolescents with T1D. Adolescents rate how often each item occurs for them on a 5 -point Likert scale from 1 (Never) to 5 (Almost Always), with higher scores indicating greater strength and resilience.
0, 3-months, 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Health System

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

December 30, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DK139431 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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