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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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 Material
Nemours Children's Hospital - FL
Orlando, Florida, United States
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
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
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
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
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
Time frame: 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.
Time frame: immediately after SSI completion
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
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
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
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