Disruptive Behaviors in Children With Tourette Syndrome: the Role of Social Cognition and Efficacy of a Parent Behavioral Training Program
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Home Situations Questionnaire (HSQ)
研究概览
简要总结
This is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome.
详细描述
Disruptive behaviors occur in 80% of children with Tourette Syndrome, and can be more disabling than the tics themselves.
The aim of this study is to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome. In addition, social cognition will be examined in all the participants to analyze its relationship with the severity of disruptive behavior and the treatment response.
42 children with Tourette Syndrome and moderate disruptive behaviors will be randomly assigned to a 10-week Parent Training Program or a 10-week Supportive Therapy. Clinical response will be evaluated after the intervention period, and three and six months later.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill DSM-5 diagnostic criteria for Tourette's Disorder
- •Moderate disruptive behaviors (Home Situations Questionnaire score >3)
排除标准
- •Lifetime history of global learning disability, autism spectrum disorder, psychosis, bipolar disorder or organic brain disorder.
- •Previous parent training with qualified therapist within the last 12 months prior to assessment
- •Simultaneous individual treatment for disruptive behaviors.
- •Initiation or adjustment of any psychotropic medication within the last 6 weeks prior to assessment
研究组 & 干预措施
Parent training (PT)
The PT arm receives a 10-week therapist-guided behavioral group treatment. The treatment is based on existing literature for training parents in child behavior management skills (Barkley 1999). Parents attend weekly sessions, which last 90 minutes and are held at the Hospital Clinic of Barcelona. Parents are given homework assignments to complete between sessions.
干预措施: Parent Training (Behavioral)
Supportive Therapy (ST)
The ST arm receives a 10-week supportive group treatment. Parents are invited to discuss relevant problems that have occurred during the previous week. A therapist moderate the discussion but does not provide information about the behavioral techniques included in the PT group. Parents attend weekly sessions, which last 90 minutes and are held at the Hospital Clinic of Barcelona. Parents are given homework assignments to complete between sessions.
干预措施: Supportive Therapy (Other)
结局指标
主要结局
Home Situations Questionnaire (HSQ)
时间窗: Change from baseline to week 10; 3 months follow up; 6 months follow up
Parent-rated scale with 16 items designed to assess behavioral non-compliance in regular home situations. Each item is rated on a 9-point Likert-type scale ranging from 1= "mild" to 9= "severe".
次要结局
- The Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOF)(Change from baseline to week 10; 3 months follow up; 6 months follow up)
- Yale Global Tic Severity Scale (YGTSS)(Change from baseline to week 10; 3 months follow up; 6 months follow up)
- Alabama Parenting Questionnaire(Change from baseline to week 10; 3 months follow up; 6 months follow up)
- Parent Stress Index-Short Form(Change from baseline to week 10; 3 months follow up; 6 months follow up)
研究者
Blanca Garcia-Delgar
M.D.
Hospital Clinic of Barcelona