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临床试验/NCT00183365
NCT00183365已完成1 期

Children of Depressed Parents: Family-Based Prevention

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2005年10月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
42
试验地点
2
主要终点
Child psychiatric symptomology

研究概览

简要总结

This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.

详细描述

Children of depressed parents are at risk for developing social-emotional problems. Despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. This randomized, open-label study will address the research gap by developing and pilot-testing the Protecting Families Program (PFP), a family-based, multi-component prevention program. The PFP will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14.

Prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. The purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. The interventional phase will compare PFP combined with individual parent training versus parent training alone. Participants will be randomly assigned to one of these two intervention groups. The study will last a total of 10 weeks. Both groups will meet once each week. PFP will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. Participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.

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)

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

入选标准

  • Parent is currently in treatment
  • Parent's primary DSM-IV diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified
  • Parent's child lives with him/her at least part time

排除标准

  • Parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome
  • Parent has history of bipolar or schizoaffective disorder
  • Parent's IQ is below 70
  • Parent has any serious medical or neurological disorder or condition that may prevent weekly participation
  • Parent has chronic pain that may prevent weekly participation
  • Parent or child is currently suicidal to the extent that it will interfere with outpatient treatment
  • Parent has a current substance dependence
  • Child is currently seeking psychological treatment
  • Child is mentally retarded (determined by school and clinic records)
  • Child has a clinically severe psychiatric diagnosis

研究组 & 干预措施

1

Experimental

Participants will receive the Protecting Families Program with individual parent training

干预措施: Parent Skills Training (Behavioral)

1

Experimental

Participants will receive the Protecting Families Program with individual parent training

干预措施: Protecting Families Program (PFP) (Behavioral)

2

Active Comparator

Participants will receive parent training alone

干预措施: Parent Skills Training (Behavioral)

结局指标

主要结局

Child psychiatric symptomology

时间窗: Measured immediately post-treatment and at 6-month follow-up

次要结局

  • Parenting skills, family functioning, and parent social support(Measured immediately post-treatment and at 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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