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临床试验/NCT01159041
NCT01159041已完成不适用

Evaluation of Family Focused Treatment for Childhood Depression

Boston University Charles River Campus4 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

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

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)

Experimental

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)

Active Comparator

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

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Sponsor
主要研究者

Martha C. Tompson

Associate Professor

Boston University Charles River Campus

研究点 (4)

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