NCT02154828已完成不适用
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 21
- 主要终点
- Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12
研究概览
简要总结
The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3 to 6 years with diagnosis F84.0 and F84.1 according to ICD-
- •The diagnosis should be made according to the criteria established by the recommendations on the diagnosis (FFP / HAS 2005).
- •Children supported in care units that meet the criteria defined integrative practices.
- •Children receiving a volume of hours of intervention between two and four half-days per week.
- •Written parental consent collection.
排除标准
- •Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.
结局指标
主要结局
Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12
时间窗: Month 12 (score : success or failure or emergence)
The main objective is to evaluate scare practices in autism for children 3 to 6 years
次要结局
- Global evolution thanks to CARS scale(Month 12 (score between 15 and 60))
- Global evolution of children by ECA-R scale(Month 12 (score 0 to 4))
研究者
研究点 (21)
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