Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- effectiveness of cognitive behavioral therapy program
研究概览
简要总结
This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment.
It aims yo compare the 6-month efficacy of a group CBT program versus body-mediated intervention (meditation) children (7-13 years) with ADHD-associated FASD and emotional dysregulation via a measurement of the Aggressive Behaviors subscale score of the Dysregulation Profile subset of the CBCL scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child with fetal alcohol spectrum disorder
- •child with attention deficit disorder with / without hyperactivity
- •child with a score upper than or equal to 180 points on the "Aggressive behavior", "Anxiety / Depression" and "Concentration problems" subscales of the CBCL
- •child followed in La Reunion, Montpellier or Bordeaux University Hospital
- •child whose parents are affiliated with social security
- •child who accepts to participate and whose parents have given their consent
排除标准
- •non-french speaking child or parents / non-creole speaking child or parents
- •child who already participate to CBT or body mediation groups
研究组 & 干预措施
Therapy cognitivo-comportmental
Each child will participate in a structured cognitive behavioral therapy program entitled "better manage your anger and frustration". 15 workshops is planned.
干预措施: cognitivo-comportmental therapy (Other)
Body mediation
Each child will participate in sports, artistic or fun activities involving the body (physical, emotional and communicative dimensions)
干预措施: body mediation (Other)
结局指标
主要结局
effectiveness of cognitive behavioral therapy program
时间窗: 7 months after inclusion
score on Child Behavior Check List (CBCL) scale. Minimum value = 50 (normal) and maximal value = 100 (pathologic). Score between 50 and 65 is mormal and score between 70 and 100 is pathologic and needs patients medical care.
次要结局
未报告次要终点