UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Autism Symptoms
研究概览
简要总结
Early connections has two broad goals:
- to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.
- to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.
详细描述
Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.
Participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older sibling with ASD (biologically related to participant)
- •Participant 12 months of age or younger
- •Within 1 hour of University of Washington
- •Interested in participating in Intervention
排除标准
- •Out of study area
- •Serious parent substance abuse or psychiatric history
- •Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)
- •Serious motor impairment (infant participant)
- •Significant prematurity (infant participant)
结局指标
主要结局
Autism Symptoms
时间窗: 12 months
AOSI
Mullen Receptive Language Scale
时间窗: 12 months
Mullen Receptive Language Scale SS
Communication and Symbolic Behavior Scale
时间窗: 12 months
CSBS Total Composite Score
次要结局
- Parent Child Interaction(12 months)
- Parent quality of life(12 months)
研究者
Sara Jane Webb
Associate Professor, Psychiatry and Behavioral Sciences
University of Washington