A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
- •Boys and girls between 2.0 years and 5.11 years at time of enrollment;
- •Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.
排除标准
- •Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- •Lack of availability during program hours.
研究组 & 干预措施
Center Based or In-Home Early Intervention Program
干预措施: Center Based or In Home Early Intervention Program (Behavioral)
结局指标
主要结局
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
时间窗: Baseline, 12 Weeks
Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )
次要结局
- Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.(Baseline, 12 Weeks)
- Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.(Baseline, 12 Weeks)
- Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.(Baseline, 12 Weeks)
- Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.(Baseline, 12 Weeks)
- Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.(Baseline, 12 Weeks)
研究者
Antonio Hardan
Professor
Stanford University