Tel Aviv Sourasky Medical Center
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 主要终点
- Yale Global Tic Severity Scale
研究概览
简要总结
Tourette Syndrome (TS) is a disorder characterized by motor and vocal tics. The most studied and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral Comprehensive Intervention for Tics (CBIT). Group intervention for children with TS has not been evaluated. The aim of this study is to assess the efficacy of CBIT group intervention compared with Psycho-Educational-Supportive group in terms of tic severity.
详细描述
Tourette Syndrome (TS) is a neuro-developmental disorder characterized by motor and vocal tics, frequently associated with behavioral and functional problems, impacting significantly on children's quality of life . Current evidence supports the contribution of individual behavioral treatment for TS both for reducing tics and improving children's quality of life. The most studied and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral Comprehensive Intervention for Tics (CBIT). One of the developments of behavioral treatments is group interventions, supported in various types of psychological difficulties, adding benefit of providing peer support. However, group intervention for children with TS has not been empirically evaluated.
The aim of this study is to assess the efficacy of CBIT group intervention. We hypothesize that CBIT group intervention will be more effective than Psycho-Educational-Supportive (PES) group in terms of tic severity, and that both groups will be effective in quality of life measures.
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
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Tourettes syndrome or chronic tic disorder
- •age 9-15 years
- •native Hebrew speakers
排除标准
- •intellectual disability (FSIQ < 80)
- •current diagnosis of substance abuse/dependence
- •life time diagnosis of pervasive developmental disorder, mania or psychosis.
- •previous treatment with 4 or more individual sessions of CBIT
- •Children receiving medications for tics: eligible if the dose is stable for 6 weeks prior to study with no planned changes during study participation.
结局指标
主要结局
Yale Global Tic Severity Scale
时间窗: 3 months
semi-structured clinical interview carried out with parent and child. Questions relate to tic severity over the previous week. Separate ratings are recorded for motor and phonic tics in terms of their number, frequency, intensity, complexity, and interference on a 6-point Likert scale. Three composite scores are generated which are total motor tic severity (rated from 0 to 25), total phonic tic severity (rated from 0 to 25) and total tic severity overall (rated from 0 to 50).
次要结局
未报告次要终点