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临床试验/NCT00183482
NCT00183482已完成不适用

Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2014年8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
入组人数
304
试验地点
1
主要终点
Internalizing and Externalizing symptoms in children

研究概览

简要总结

This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.

详细描述

Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents.

Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families.

Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigators and outcome assessors are masked to condition of participants.

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •for Participating Families:
  • •Families with at least one parent with a history of depression during the life of his or her child
  • •Families with at least one child between the age of 10 and 15
  • •Parent or guardian willing to provide informed consent for participating children

排除标准

  • •for All Participants:
  • •Parent with bipolar disorder or schizophrenia
  • •Child with conduct disorder or pervasive developmental disorder

研究组 & 干预措施

Family Group Cognitive Behavioral

Experimental

The intervention is a family group cognitive behavioral program for families of parents with a history of depression to teach parenting skills to parents and coping skills to children.

干预措施: Family Group Cognitive Behavioral (Behavioral)

Written Information

Active Comparator

The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.

干预措施: Written Information (Behavioral)

结局指标

主要结局

Internalizing and Externalizing symptoms in children

时间窗: 12 months

Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome

次要结局

  • Depressive symptoms in parents(12 months)
  • Parenting skills of parents(12 months)
  • Onset of depressive disorders in children(12 months)
  • Coping skills of children(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruce Compas

Patricia and Rodes Hart Professor

Vanderbilt University

研究点 (1)

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