Within Subject Design on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents With Tics
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of a habit reversal 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 a habit reversal based treatment programme for children and adolescents with tic disorders. This habit reversal treatment programme was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in a pilot-study (Woitecki & Döpfner, 2011, 2012).
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
结局指标
主要结局
Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
时间窗: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 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 in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating(Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3))
- Change in Symptom Checklist for Tic-Symptoms, clinical rating(Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24 weeks (T3))
- Change of comorbid OCD Symptoms (ZWIK-E), parent-rating(T0, after 8 weeks (T1), 24 weeks (T3))
- Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating(T0, after 8weeks (T1), 24weeks (T3))
- Change in Tic-Symptoms (YGTSS-TIC), overall score(Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3))
- Change in self-esteem (Harter-Scale-SBB)(self rating)(T0, after 8 weeks (T1), 24weeks (T3))
- Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating(T0, after 8 weeks (T1), 24weeks (T3))
- Change in Tic-Symptoms (observation)(Between T1 and T3 up to 16 weeks, during each session/week)
研究者
Manfred Doepfner
Leading psychologist at the Department of Childhood and Adolescence Psychiatry
University of Cologne