Health TrialsbyHealthPanel

Adapting Single Sessions Interventions for Type 1 Diabetes

ConditionType 1 Diabetes (T1D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorNemours Children's Health System

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 Educational

    Behavioral

    T1D Educational Material

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: T1D-specific depression SSIExperimental treatment 1 intervention
Group B: T1D EducationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
0, 3-months, and 6-months
2

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

Time frame
0, 3-months, and 6-months
3

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.

Time frame
7 days before and 7 days after SSI
4

Mood and Feelings Questionnaire (MFQ)

The MFQ is a 13-item measure that assesses depressed mood in youth. Higher scores indicate higher depressed mood.

Time frame
7 days before and 7 days after SSI

Secondary outcomes

1

Problem Areas in Diabetes- Teen (PAID-T)

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.

Time frame
0, 3-months, and 6-months
2

Diabetes Family Conflict Scale- Revised (DFCS-R)

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.

Time frame
0, 3-months, and 6-months
3

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

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.

Time frame
0, 3-months, 6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nemours Children's Health System

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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