Evaluating Parent Delivered Interventions for Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in CGI-S (Clinical Global Impression - Severity)
研究概览
简要总结
The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for autism participants:
- •Children between the ages of 1.6 and 17.11 years of age
- •Males and females
- •Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed
- •Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder
- •Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject
- •Inclusion Criteria for developmentally delayed participants:
- •Will have an age range between 1.6 and 17.11 years of age
- •Males or females
- •Diagnosis of a developmental delay or disorder based on DSM-IV-TR, ICD-10, and an expert clinical evaluation
- •Have historical evidence of significant abnormal developmental milestones as determined by neurological history
- •Receiving or will receive a parent delivered intervention
- •Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject
排除标准
- •for autism participants:
- •Is medically unstable (e.g., more than one seizure a month)
- •Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
- •Exclusion Criteria for developmentally delayed subjects:
- •Is medically unstable (e.g., more than one seizure a month)
- •Has a diagnosis of ASD
研究组 & 干预措施
Developmentally Based Intervention
干预措施: PACE Therapy (Behavioral)
Developmentally Based Intervention
干预措施: PACE and PRT Hybrid (Behavioral)
Behaviorally Based Intervention
干预措施: Pivotal Response Training (PRT) (Behavioral)
Behaviorally Based Intervention
干预措施: PACE and PRT Hybrid (Behavioral)
结局指标
主要结局
Change in CGI-S (Clinical Global Impression - Severity)
时间窗: Difference from Baseline to Week 12
Change in SRS (Social Responsiveness Scale)
时间窗: Difference from Baseline to Week 12
Change in CDI (Communicative Development Survey) Score
时间窗: Difference from Baseline to Week 12
Change in social and communication behaviors as assessed by standardized laboratory observations
时间窗: Difference from Baseline to Week 12
次要结局
- Change in VABS (Vineland Adaptive Behavior Scale) Score(Difference from Baseline to Week 12)
- Change in social and communication behaviors as assessed from home videos(Difference from Baseline to Week 12)
- Change in PSI (Parenting Stress Index) Score(Difference from Baseline to Week 12)
- Change in frequency and duration of investigation therapy(Difference from Baseline to Week 12)
- Change in demographics data(Difference from Baseline to Week 12)
- Change in FES (Family Empowerment Scale) Score(Difference from Baseline to Week 12)
研究者
Antonio Hardan
Associate Professor
Stanford University