Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Receptive language skills
研究概览
简要总结
This study will determine the impact of early intervention on the communication and social development of toddlers with autism.
详细描述
Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.
Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 33 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism spectrum disorder
- •Parent or guardian willing to give informed consent for child's participation
- •Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
- •English is primary language for child and family
排除标准
- •Evidence of vision or hearing impairment
- •Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
- •History of severe birth trauma or traumatic brain injury
- •Siblings with autism spectrum disorder
结局指标
主要结局
Receptive language skills
时间窗: Pre-tx, Post-tx, and 6 month follow up
Expressive language skills
时间窗: Pre-tx, Post-tx, and 6 month follow up
次要结局
- Social cognitive skills(Pre-tx, Post-tx, and 6 month follow up)
- Social emotional functioning(Pre-tx, Post-tx, and 6 month follow up)
- Play skills(Pre-tx, Post-tx, and 6 month follow up)
研究者
Rebecca Landa
Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.