Adapting Single Sessions Interventions for Type 1 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes (T1D)

• Registration Number: NCT06752369
• Lead Sponsor: Nemours Children's Health System

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study Start: 2025-02
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2028-08
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	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
Patient Health Questionnaire for Adolescents (PHQ-9)	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
Positive and Negative Affect Schedule (PANAS)	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.
Mood and Feelings Questionnaire (MFQ)	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.
Feasibility of T1D-specific Depression SSI	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
Acceptability of Healthcare Interventions Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Problem Areas in Diabetes- Teen (PAID-T)	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.
Diabetes Family Conflict Scale- Revised (DFCS-R)	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.
Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)	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.

Trial Locations

Locations (1)

Nemours Children's Hospital - FL; 🇺🇸 Orlando, Florida, United States