Randomized Controlled Trial of the P.L.A.Y. Project Intervention for Autism

描述(由申请人提供)：为患有自闭症谱系障碍(ASD)的儿童开发一种[基于证据]、成本效益高和[易于传播]的强化干预形式是该国卫生和教育系统的主要优先事项。疾控中心最新的自闭症患病率估计为每150名儿童中有1人患有自闭症。根据国家研究理事会的说法，这些儿童需要密集干预(每周25小时，师生比例为1：1或1：2)，大多数州没有提供这种干预，原因是a)全国缺乏训练有素的人员，b)由专业人员提供的此类干预非常昂贵(25-6万美元)，c)尚未开发出以证据为基础、易于传播、成本效益高的模式，并对其进行全国分发测试。未得到满足的国家需求是巨大的。P.L.A.Y.项目(自闭症青少年的游戏和语言)家庭咨询模式(PLAY)是一种创新的培训培训者的解决方案，潜在地满足了这一全国性需求。利用格林斯潘的指导/发展框架，以及包括视频反馈在内的高度结构化的教育方法，家庭顾问培训父母如何成为孩子最好的游戏伙伴，而费用只有专业人士提供密集服务的十分之一(4K美元)。来自试点研究的初步临床证据表明，该模型很有前途。父母学会了玩耍的方法，干预组的孩子在临床和统计上都有改善。此外，在刚刚完成的第一阶段SBIR对照研究中，2个干预点和2个对照点各招募了20名患有ASD的儿童。在与复活节海豹突击队和密歇根州立大学的密切合作下，赠款成功地试行了执行第二阶段试验所需的程序。对照研究确定了进行更大规模第二阶段试验的可行性，对照研究结果令人鼓舞，尽管数量很少，干预也很短暂。该模型也已成功地传播到社区机构、学校和医院的现实世界环境中。第二阶段试验的假设是，Play的父母培训干预模式可以显著改善患有自闭症的幼儿的发展结果。如果试验成功，将鼓励私营保险公司和政府机构批准大幅增加自闭症密集干预服务的资金，从而使这一模式得到广泛传播，Play的业务大幅增长，并带来显著的社会效益。公共卫生相关性：P.L.A.Y.项目培训父母为患有自闭症的幼儿提供强化干预。我们建议进行一项随机对照临床试验，以证明这种干预模式在社区环境中的有效性。一项成功的研究可能会影响到照顾自闭症儿童的国家战略。

DESCRIPTION (provided by applicant): The development of an [evidence-based], cost-effective and [easily disseminated] form of intensive intervention for children with autistic spectrum disorders (ASD) is a major priority for both the health and education systems in this country. The most recent prevalence estimate for ASD from the CDC is 1 in 150 children. According to the National Research Council, these children need intensive intervention (25 hours/week, 1:1 or 1:2 teacher to pupil ratio), which most states do not provide because a) there is a national shortage of trained personnel, b) such interventions when provided by professionals are very expensive ($25-60K) and c) an evidence-based, readily disseminated, cost-effective model has not yet been developed and tested for national distribution. The unmet national need is enormous. The P.L.A.Y. Project (Play and Language for Autistic Youngsters) Home Consultation model (PLAY) is an innovative train-the-trainer solution to potentially address this national need. Using Greenspan's DIR/developmental framework, and a highly-structured educational approach including video feedback, home consultants train parents how to be their child's best PLAY partner for one-tenth the cost ($4K) of having professionals providing intensive services. Preliminary clinical evidence from a pilot study indicates that the model is promising. Parents learned the methods PLAY and children in the intervention group showed clinical as well as statistical improvements. Furthermore, in the Phase I SBIR controlled study just completed, 2 intervention and 2 control sites each enrolled 20 children with ASD. In close partnership with Easter Seals and Michigan State University, the grant successfully piloted the procedures needed for execution of the Phase II trial. The controlled study established the feasibility of doing a larger Phase II trial and control study results, despite small numbers and brief intervention, were encouraging. Early dissemination of the model into the real world settings of community agencies, schools, and hospitals has also been successfully accomplished. The hypothesis for the Phase II trial is that PLAY's parent-training intervention model can significantly improve developmental outcomes for young children with autism. A successful trial would encourage private insurers and government agencies to approve major increases in funding for autism intensive intervention services, resulting in wide dissemination of this model, substantial growth in PLAY's business, and significant social benefit. PUBLIC HEALTH RELEVANCE: The P.L.A.Y. Project trains parents to provide intensive intervention for their young children with autism. We are proposing to carry out a randomized controlled clinical trial to demonstrate effectiveness of this intervention model in community settings. A successful study could impact the national strategies for caring for children with autism.