Family Cognitive Behavioral Prevention of Depression in Youth and Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 4
- 主要终点
- In children, the primary outcome is level of symptoms on the Youth Self-report form.
研究概览
简要总结
The primary aim is to prevent depression in youth and parents in a single, integrated family intervention.
Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition.
Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.
详细描述
Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This "dual prevention" approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (10 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Interviewers who assess diagnostic outcomes are masked to participant condition.
入排标准
- 年龄范围
- 9 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent with a current or history of a depressive disorder within child's life
- •Children ages 9- to 15-years-old
排除标准
- •Bipolar I (parent or child)
- •Schizophrenia (parent or child)
- •Current alcohol or drug abuse (parent or child)
- •Conduct disorder; developmental disability (child)
- •Current diagnosis of a depressive disorder (child)
结局指标
主要结局
In children, the primary outcome is level of symptoms on the Youth Self-report form.
时间窗: twelve months post baseline
For child participants, we will assess change in their levels of symptoms on the Youth Self-report form at 12-month follow-up. T-scores range from 0 to 100; higher scores indicate more symptoms (i.e., worse outcome).
次要结局
- In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child(12 months)
- Parents: Patient Health Questionnaire - 9 (PHQ-9)(12 months)
- Children: depressive diagnoses(12 months)
研究者
Judith Garber
Professor
Vanderbilt University
