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临床试验/NCT02190370
NCT02190370Unknown不适用

Within Subject Design on the Efficacy of a Resources Activation Treatment Programme in Children and Adolescents With Tics

University of Cologne1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Change in self-esteem (Harter-Scale-SBB)(self rating)

研究概览

简要总结

The main purpose of this study is to evaluate the efficacy of a resources activation based treatment programme in children and adolescents aged 8 to 18 years with tic disorders.

详细描述

The main purpose of this study is to evaluate the efficacy of an intervention aimed at the activation of resources for children and adolescents with tic disorders. The activation of resources treatment programme was developed at Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and is currently evaluated in different studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •8-18 years
  • •Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
  • •YGTSS total score F95.2>13, F95.1>9
  • •Tics are the main problems
  • •If medication, then has been stable for at least one months in medicated patients
  • •No change in medication treatment is planned
  • •Ability to participate in weekly outpatient treatment
  • •Acceptance of randomization

排除标准

  • •Diagnosis of Autism Spectrum Disorder or Psychosis
  • •Parallel continuous psychotherapy of tics or comorbid

研究组 & 干预措施

Resources activation

Experimental

At first patients get informed about Tics in general. Through different exercises existing resources and skills are activated and strengthened. Feeling of self-esteem and self-respect are strengthened. Also the emotional awareness is strengthened. Relaxation methods are also introduced.

干预措施: Resources activation (Behavioral)

结局指标

主要结局

Change in self-esteem (Harter-Scale-SBB)(self rating)

时间窗: T0, after 8 weeks (T1), 24weeks (T3)

The Harter-Scale is used to assess self-esteem

Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating

时间窗: Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)

The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents

次要结局

  • Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating(T0, after 8 weeks (T1), 24 weeks (T3))
  • Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating(Baseline (T0), after 8 weeks (T1), 16 weeks (T2), 24weeks (T3))
  • Change in Symptom Checklist for Tic-Symptoms, clinical rating(Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3))
  • Change in Tic-Symptoms (observation)(Between T1 and T3 up to 16 weeks, during each session/week)
  • Change of comorbid OCD Symptoms (ZWIK-E), parent-rating(T0, after 8 weeks (T1), 24weeks (T3))
  • Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating(T0, after 8 weeks (T1), 24weeks (T3))
  • Change in Tic-Symptoms (YGTSS-TIC), overall score(Baseline (T0), after 8 weeks (T1),16weeks (T2), 24weeks (T3))

研究者

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

Manfred Doepfner

Leading psychologist at the Department of Childhood and Adolescence Psychiatry

University of Cologne

研究点 (1)

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