A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
研究概览
简要总结
Thirty two children age 2-6 years are recruited into the study and the randomization will be stratified for chronological age and symptom severity into 2 main groups, intervention and control. The intervention group will receive an additional target treatment of DIR/Floortime parent training intervention, while the control group will continue on their routine care for 3 months.
Hypothesis: Children in the intervention group show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.
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 (Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical criteria for Autistic Disorders according to DSM IV
- •child is 2 - 6 years of age
排除标准
- •children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures)
- •children who are geographically inaccessible for follow-up visits
- •their parents are not literate or known chronic psychiatric or physical illness in the parents
研究组 & 干预措施
DIR/Floortime intervention
1=DIR/Floortime intervention
干预措施: DIR/Floortime (Behavioral)
routine care
2=routine care
干预措施: Routine care (Behavioral)
结局指标
主要结局
The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
时间窗: at the beginning of the first session and at the 3 months follow up
次要结局
- The Childhood Autism Rating Scale (CARS) Clinical rating of the children (6 point scale related to Greenspan's six Functional Development Level -FDL) Satisfaction of the effectiveness of the intervention of their child (Six-point Likert scale)(at the beginning of the first session and the 3 months follow up)