Randomized Control Trial on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents - a Comparison With Resource Activation Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24
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 compared to an alternative treatment which aims at the activation of resources 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 (THICS, Woitecki & Döpfner, 2014) compared to an intervention aimed at the activation of resources (STARK, Perri et al., 2014) 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). The activation of resources treatment programme was also developed at this Department and is currently evaluated in different studies. Effects are expected in both interventions, but a larger effect is expected in the THICS 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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Intelligence IQ>80
- •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 from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24
时间窗: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
Change in Quality of Life (Tic-HRQoL-FBB)(parent rating)
时间窗: eight weeks (T1) and twenty-four weeks (T3)
The Tic-HRQoL-FBB is used to assess impairment and quality of life through tic symptoms and other comorbid symptoms rated by parents
次要结局
- Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating(eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3))
- Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating(eight weeks (T1), and 24 weeks (T3))
- Change of comorbid OCD Symptoms (ZWIK-E), parent-rating(eight weeks (T1), and 24 weeks (T3))
- Change in self-esteem (Harter-Scale-SBB)(self rating)(eight weeks (T1), and 24 weeks (T3))
- Change in Tic-Symptoms (observation)(24 weeks (weekly assessment))
- Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating(eight weeks (T1), and 24 weeks (T3))
- Change in Tic-Symptoms (YGTSS-TIC), overall score(eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3))
- Change in Symptom Checklist for Tic-Symptoms, clinical rating(eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3))
研究者
Manfred Doepfner
Leading psychologist at the Department of Childhood and Adolescence Psychiatry
University of Cologne