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临床试验/NCT00533806
NCT00533806已完成3 期

Family Based Treatment for Early Childhood OCD

Rhode Island Hospital6 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
127
试验地点
6
主要终点
Children's Yale-Brown Obsessive Compulsive Scale

研究概览

简要总结

This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder.

详细描述

Obsessive-compulsive disorder (OCD) is a type of anxiety disorder that affects approximately 1 in 200 children. Although feelings of anxiety, fear, and uncertainty are a normal part of life and growing up, for some children these feelings and emotions become chronic, relentless, and progressively worse if left untreated. OCD is characterized by obsessions, or repeated unsettling thoughts, causing a person to perform repeated actions called compulsions. Children are typically not diagnosed with OCD until they are between the ages of 8 and 12, leaving many young children undiagnosed. Additionally, no psychotherapy treatments have been designed for young children who are under the age of 8 and have OCD. The purpose of this study is to develop and evaluate a family-based treatment program for children, ages 5 to 8, who have been diagnosed with OCD.

Participants in this open-label study will be randomly assigned to receive either cognitive behavior therapy (CBT) or relaxation therapy for 12 sessions over a period of 14 weeks. All children will undergo a 3-hour screening that will include a psychiatric evaluation and the completion of questionnaires. Parents of participating children will attend the first two treatment sessions without their children during which they will be introduced to the treatment program and will learn various skills to be used throughout treatment. The other 10 1-hour sessions will be attended by both the parent and child. Participants assigned to receive CBT will learn skills to help control OCD. Education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management will be included in the CBT sessions. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. Treatment will also include education about OCD; affective education, during which participants will learn how to recognize feelings; muscle relaxation techniques; and guided imagery. Participants in both treatment groups will receive weekly homework assignments after each session to practice skills learned. Parents will also be asked to monitor their child's behavior and practice the learned skills with their child as often as possible. If treatment has not been successful after the 14-week period, the child will be offered an alternative treatment. All participants will be assessed before treatment; at 5, 9, and 14 weeks of treatment; and at 3, 6, and 12 months after treatment.

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
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Meets DSM-IV criteria for OCD
  • Parent willing to sign informed consent

排除标准

  • History or current diagnosis of pervasive developmental disorder(s), thought disorder, or mental retardation
  • Psychotic symptoms

结局指标

主要结局

Children's Yale-Brown Obsessive Compulsive Scale

时间窗: Measured immediately post-treatment and at Months 3, 6, and 12

次要结局

  • Clinical Global Improvement(Measured immediately post-treatment and at Months 3, 6, and 12)

研究者

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

Jennifer B. Freeman

Director, Outpatient Child Psychiatry; Staff Psychologist

Rhode Island Hospital

研究点 (6)

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