Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes (T1D)
- Sponsor
- Nemours Children's Health System
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c (HbA1c)
- Status
- Not yet recruiting
- Last Updated
- 3 months ago
Overview
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:
- Is a single-session depression intervention for youth with T1D feasible to recruit and implement?
- Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?
- 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
Investigators
Alexandra Monzon
Assistant Research Scientist
Nemours Children's Health System
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Hemoglobin A1c (HbA1c)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)