Type 1 Diabetes (T1D)
Conditions
Keywords
type 1 diabetes, adolescents, depression
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
Interventions
BEHAVIORALT1D-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.
BEHAVIORALT1D Educational
T1D Educational Material
Sponsors
Nemours Children's Health System
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTAlexandra Monzon, PhD
Outcome results
None listed