NCT00954083已完成不适用
A Pilot Randomized Controlled Trial of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
适应症
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
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)
研究者
相似试验
Unknown
4 期
Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam for Control of Seizures in ChildrenSeizuresNCT04885075Shaheed Zulfiqar Ali Bhutto Medical University60
已完成
2 期
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) PopulationUpper Respiratory Tract InfectionsNCT00965822Afexa Life Sciences Inc293
撤回
2 期
Xylitol for Otitis MediaOtitis Media With EffusionNCT02950311Duke University
Unknown
不适用
Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and IntensityADHDNCT01795053University of Cologne60
已完成
不适用
Baby Dvd Effects on CortisolInfant DevelopmentNCT01459848Seattle Children's Hospital50