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临床试验/NCT00073645
NCT00073645已完成1 期

Therapy Specificity and Mediation in Family and Group CBT

Florida International University1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2002年7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
241
试验地点
1
主要终点
ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)

研究概览

简要总结

This study will compare the effectiveness of family- and peer-oriented therapy in treating children with anxiety disorders and will also test for therapy specificity effects and potential mediators of outcome.

详细描述

Data suggest that individual Cognitive Behavior Therapy (CBT) is effective in reducing anxiety disorders in children. The incorporation of parents and peers in a CBT treatment program also has been found to be effective in reducing anxiety symptoms, because a child's environment (i.e., parents, peers) affect the development, course, and outcome of childhood anxiety and functional status. Children and their parents will be randomly assigned to one of two treatment conditions: Family/Parents CBT (FCBT) or Peer/Group CBT (GCBT) for 14 to 16 weekly sessions. Parent-child relationships are the focus of FCBT. Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children. Children in the GCBT group will be trained to be more helpful and positive toward other children through role-playing activities. Interviews, questionnaires, and behavior observation tasks will be used to assess participants. All participants will be assessed at pretreatment, post-treatment, and at yearly follow-up visits. The first set of hypotheses that will be tested is that FCBT will produce significantly greater specific effects on parenting skills and parent-child relationships than on child social skills and peer-child relationships. GCBT, on the other hand, will produce significantly greater specific effects on child social skills and peer-child relationships than on parenting skills and parent-child relationships. The second set of hypotheses will test whether or not it is the changes that are produced on these variables that mediate treatment response. Thus, the second set of hypotheses that will be tested is that parenting skills, parent-child relationships, child social skills and/or peer-child relationships will be significant mediators of treatment response, i.e., anxiety reduction

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
None

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •DSM-IV criteria for Generalized Anxiety Disorder (GAD), Social Phobia (SP), or Separation Anxiety Disorder (SAD)
  • •Mean score >= 4 on the Clinician's Rating Scale of Severity
  • •Discontinuation of all other psychosocial treatment upon consultation with clinic staff and the service provider

排除标准

  • •DSM-IV criteria for a disorder other than GAD, SP, and SAD
  • •Diagnosis of any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, or schizophrenia and other psychotic disorders
  • •At risk for harm to self or others

研究组 & 干预措施

1

Experimental

Family/Parents CBT (FCBT) for 14 to 16 weekly sessions

干预措施: Family/Parents CBT (Behavioral)

2

Active Comparator

Peer/Group CBT (GCBT) for 14 to 16 weekly sessions

干预措施: Peer/Group CBT (Behavioral)

结局指标

主要结局

ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)

时间窗: pre, post, and followup

次要结局

  • Children's Manifest Anxiety Scale - Revised (RCMAS; Reynolds & Richmond, 1978) and Internalizing subscale of the Child Behavior Checklist (CBCL; Achenbach, 1991)(pre, post, followup)

研究者

申办方类型
Other

研究点 (1)

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