Evaluation of Family Focused Treatment for Childhood Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 4
- 主要终点
- Adequate Depression Treatment Response
研究概览
简要总结
This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.
详细描述
Childhood-onset depression is an impairing and often recurrent and persistent disorder that impacts current and later development resulting in high personal, social, and economic costs. Despite the costs of early-onset depression, the emphasis in current practice parameters on an initial course of psychosocial treatment, and extensive research on adolescent depression, we currently lack randomized controlled trials evaluating psychosocial treatments for children with depressive disorders.
The present proposal aims to address this gap in knowledge regarding optimal psychosocial treatment strategies for children suffering from depressive disorders. We propose a 2-site randomized controlled trial to evaluate the efficacy of Family Focused Treatment (FFT), as compared to an individual client-centered psychotherapy (IP) modeled after "usual" community care. FFT adopts an interpersonal model for understanding how depressive symptoms are maintained, emphasizes developing family skills/strategies for altering interpersonal processes, and works on building a family environment that supports recovery and enhances stress resistance and resilience. This approach may be particularly appropriate to the developmental needs of depressed children, given their dependence on parents, the potential of FFT to address the needs of multiple family members, and our data supporting benefits on depression, functioning, and other co-occurring symptoms.
The proposed project will enroll 140 children (ages 8-12) with depressive disorders. Children will be randomly assigned to receive a 14-week trial of either FFT or IP. At study entry, immediately post-treatment, and at a 9-month post-treatment follow-up all participants will undergo intensive evaluation of clinical state and psychosocial and family functioning.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current Depressive Disorder
- •ages 7-13 years
- •living with at least one biological parent willing to participate
排除标准
- •thought disturbance
- •severe conduct disorders
- •unstable on antidepressant medications
- •continuation in current non-study treatment
- •non-English speaking
研究组 & 干预措施
Family Focused Treatment (FFT)
15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery.
干预措施: Family Focused Treatment (FFT) (Behavioral)
Individual Treatment (IP)
15 session individually-based treatment to assist children in understanding the causes of their symptoms.
干预措施: Individual Treatment (IP) (Behavioral)
结局指标
主要结局
Adequate Depression Treatment Response
时间窗: 3 months
50% improvement on Children's Depression Rating Scale-Revised
次要结局
- Children's Self-Report of Depression Symptoms(3 Months)
- Interviewer-rated Depression Severity(3 Months)
研究者
Martha C. Tompson
Associate Professor
Boston University Charles River Campus
