Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
T1D Education
Educational material about T1D
干预措施: T1D Educational (Behavioral)
T1D-specific depression SSI
Single session depression intervention adapted for youth with T1D. 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.
干预措施: T1D-specific depression SSI (Behavioral)
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Alexandra Monzon
Assistant Research Scientist
Nemours Children's Health System