Adapting Single Sessions Interventions for Type 1 Diabetes

NCT06752369 | Not Yet Recruiting DMC

• 1 other identifier: K23DK139431
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

• 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)

Keywords

type 1 diabetes; adolescents; depression

Outcome Measures

Primary Outcomes (6)

• Hemoglobin A1c (HbA1c)

  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)

  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)

  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)

  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

  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

  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 Outcomes (3)

• Problem Areas in Diabetes- Teen (PAID-T)

  0, 3-months, and 6-months

• Diabetes Family Conflict Scale- Revised (DFCS-R)

  0, 3-months, and 6-months

• Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)

  0, 3-months, 6-months

Study Arms (2)

T1D-specific depression SSI

EXPERIMENTAL

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

T1D Education

PLACEBO COMPARATOR

Educational material about T1D

Behavioral: T1D Educational

Interventions

T1D-specific depression SSI BEHAVIORAL

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-specific depression SSI

T1D Educational BEHAVIORAL

T1D Educational Material

T1D Education

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Health System: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Nemours Children's Hospital - FL

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Alexandra Monzon, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: March 2, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)