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临床试验/NCT01350986
NCT01350986Unknown不适用

Efficacy of Cognitive-Behavioral Based Guided Self-Help for Parents of Children With Externalizing Problem Behavior

German Research Foundation2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
146
试验地点
2
主要终点
Change Oppositional Defiant Disorder subscale score of the Symptom Checklist Disruptive Behavior Disorder (SCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)

研究概览

简要总结

The efficacy of cognitive-behavioral based guided self-help for parents of children with externalizing problem behavior is tested in a randomized clinical trial. Parents work through cognitive-behavioral self-help booklets and additionally receive counseling telephone calls every two weeks. In the control condition parents are provided non-directive self-help booklets and additionally receive counseling telephone calls. It is hypothesized that the cognitive-behavioral treatment is superior.

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 (Participant)

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child diagnosis of ODD and/or ADHD based on DCL-ODD and DCL-ADHD respectively

排除标准

  • Child IQ is below 80
  • Child has diagnosis of pervasive developmental disorder (PDD)
  • Indication for inpatient/intensive treatment for child
  • Parent training while intervention period
  • Planed start, change or discontinuation of psychopharmacological treatment for child while intervention period
  • No parental adherence or willingness for randomisation process
  • Language or reading difficulties of participating parent

结局指标

主要结局

Change Oppositional Defiant Disorder subscale score of the Symptom Checklist Disruptive Behavior Disorder (SCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)

时间窗: pre, intermediate, post, 6-month FU, 12-month FU

Questionnaire considers the diagnostic criteria of DSM-IV and ICD-10 for ODD. Informant is participating parent.

Change total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)

时间窗: pre, intermediate, post, 6-month FU, 12-month FU

Questionnaire considers the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.

Change Oppositional Defiant Disorder subscale score of the Diagnostic Checklist Disruptive Behavior Disorder (DCL-ODD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)

时间窗: pre, intermediate, post, 6-month FU, 12-month FU

Diagnostic interview considers the criteria of DSM-IV and ICD-10 for ODD. Informant is mental health worker.

Change total score of the Diagnostic Checklist Attention-Deficit/Hyperactivity Disorder (DCL-ADHD; Döpfner, Görtz-Dorten, & Lehmkuhl, 2008)

时间窗: pre, intermediate, post, 6-month FU, 12-month FU

Diagnostic interview considers the criteria of DSM-IV and ICD-10 for ADHD. Informant is mental health worker.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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