Supporting Treatment Adherence Needs in Diabetes: The STAND Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
研究概览
简要总结
There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-17
- •Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
- •Daily insulin dosing of at least 0.5 units per kilogram per day
- •Clinical elevation on the CDI (i.e., score at or above 13)
- •Assent to participation in study
排除标准
- •Other chronic, physical disease or condition except for celiac or thyroid disease
- •Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
- •Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
- •Current enrollment in psychotherapy specifically targeting depression
结局指标
主要结局
Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
时间窗: Assessed at 0, 1.5, 3, and 6 months after enrollment
Diabetes-Related Family Conflict Scale (DFCS)-Measure of family conflict around diabetes-specific tasks
时间窗: Assessed at 0, 1.5, 3, and 6 months from enrollment
次要结局
- Hemoglobin A1c value(Obtained at 0, 3, and 6 months after enrollment)