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临床试验/NCT01761396
NCT01761396已完成不适用

Modular CBT for Reducing Anxiety and Improving Educational Outcomes

UConn Health1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2012年7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
216
试验地点
1
主要终点
Clinical Global Impressions Improvement Scale

研究概览

简要总结

This research is being done to compare two types of talk therapy to see which is most effective in helping school children with anxiety disorders. The investigators will compare usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered by the school mental health counselors to see if they help children with anxiety disorders to feel less scared or worried.

详细描述

This four year study involves a blocked randomized controlled trial (RCT) comparing the effectiveness of school-based CBT to usual care (UC) for approximately 375 students ages 7-17 diagnosed with an anxiety disorder. Randomization will occur at the school level and the investigators propose to conduct the study in approximately 46 schools (23 in CBT; 23 UC). Evaluations will be conducted by study staff to measure treatment progress at the end of the 12-week treatment program, at a three month follows up, and at natural termination.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •between the ages of 6-18 inclusively
  • •meet DSM-IV criteria for a primary anxiety disorder

排除标准

  • •presence of a medical or psychiatric condition contraindicating study treatment (e.g., suicidal intent)
  • •need more immediate or alternative treatment
  • •receiving psychosocial treatment for anxiety
  • •victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision

研究组 & 干预措施

CBT

Experimental

Cognitive behavioral therapy

干预措施: CBT (Behavioral)

UC

Active Comparator

Usual care

干预措施: UC (Behavioral)

结局指标

主要结局

Clinical Global Impressions Improvement Scale

时间窗: 12 weeks post-treatment

Improvement in Clinical Anxiety Diagnosis

次要结局

  • School Records(12 weeks post-treatment)
  • Teacher Report Form(12 weeks post-treatment)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Golda S. Ginsburg

Professor

UConn Health

研究点 (1)

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