Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
研究概览
简要总结
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
详细描述
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Disease Characteristics--
- •Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
- •Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
- •-Patient Characteristics--
- •Must reside within 60 km (37.5 miles) of a treatment site
排除标准
- •Severe medically induced limitations defined as:
- •Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
- •Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
- •Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
- •Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
结局指标
主要结局
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
时间窗: yearly for up to 4 years
IQ
Bayley Scales of Infant Development
时间窗: yearly for up to 4 years
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
次要结局
- Merrill-Palmer Scale of Mental Tests(yearly for up to 4 years)
- Vineland Adaptive Behavior Scales - Survey Edition(yearly for up to 4 years)
- Reynell Developmental Language Scales(yearly for up to 4 years)
研究者
Tristram Smith, Ph.D.
Professor of Pediatrics
University of Rochester