PILOT STUDY FOR CONTROLLED TRIAL OF THE P.L.A.Y. PROJECT INTERVENTION FOR AUTISM

描述（由申请人提供）：开发可复制的、具有成本效益的密集干预措施来治疗患有自闭症谱系障碍（ASD）的幼儿，是我国和国际卫生和教育系统的优先事项。最近对自闭症谱系障碍患病率的估计范围从4/1000到6.5/1000。此外，尽管被确诊为自闭症谱系障碍的儿童数量正在增加，但在这些方法方面受过培训的人员在全国范围内仍然短缺。美国国立卫生研究院指出，自闭症的早期干预和多地点随机临床试验都是研究的重中之重，美国国家科学院的报告强调密集（每周25小时，1:1或1:2的师生比例），参与和全面的干预。ASD儿童的高患病率加上对密集干预的需求，意味着需要非常大量的资源来有效地治疗自闭症。鉴于大多数州通常不为密集干预提供广泛支持，未满足的国家需求是巨大的。基于格林斯潘的理论dir框架，我们开发了一种创新的解决方案，为解决这一国家需求做出贡献。这个项目被称为“p.l.a.y项目”（自闭症儿童的游戏和语言），我们有初步的临床证据表明这种父母训练模式是有效的。该模式在社区机构、学校和医院的早期推广也已成功完成，从而与一个主要的国家伙伴————复活节印章————建立了联盟。现在我们准备组织一个严格的临床试验。我们的假设是，可以组织一组随机、对照、基于社区的临床试验，以检验父母训练干预模式是否可以改善年幼自闭症儿童的功能结局。在第一阶段，我们建议在密歇根州立大学的指导下对这些程序进行试点，以便在第二阶段进行全面试验。复活节印章将为第一期和第二期提供社区用地。第二阶段试验的成功将为广泛传播奠定基础。我们这个项目的长期目标是广泛传播这种模式，并制定解决国家需要的战略。成功的试验将为鼓励私营保险公司和政府机构批准大幅增加对自闭症密集干预服务的资金提供支持，从而使这种模式得到广泛传播，使我们的业务得到大幅增长，并带来显著的社会效益。

DESCRIPTION (provided by applicant): The development of replicable, cost-effective intensive interventions for the treatment of young children with autistic spectrum disorders (ASD) is a priority for both the health and education systems in this country and internationally. Recent prevalence estimates for ASD range from 4/1000 to 6.5/1000 children. Additionally, there is a national shortage of personnel trained in these approaches even as the number of children identified with ASDs is increasing. The NIH has indicated that early interventions and multi-site randomized clinical trials in autism are each high priorities for research and National Academy of Sciences report emphasizes intensive (25 hours/week, 1:1 or 1:2 teacher:pupil ratios), engaging and comprehensive interventions The combination of high prevalence of children with ASD coupled with the need for intensive intervention means that very substantial resources are required to effectively address autism. Given that most states do not typically provide broad support for intensive interventions, the unmet national need is enormous. Based on the theoretical DIR-framework of Greenspan, we have developed an innovative solution to contribute to addressing this national need. This program is called "The P.L.A.Y. Project" (Play and Language for Autistic Youngsters) and we have preliminary clinical evidence to show that this parent training model is effective. Early dissemination of the model into community agencies, schools and hospitals has also been successfully accomplished, leading to establishment of an alliance with a major national partner -- Easter Seals. Now we are prepared to organize a rigorous clinical trial. Our hypothesis is that a group randomized, controlled, community-based clinical trial can be organized to test whether a parent-training intervention model can improve functional outcomes for young children with autism. In Phase I we are proposing to pilot the procedures, with guidance from Michigan State University, to be used in the full trial to be conducted in Phase II. Easter Seals will provide the community sites for both Phase I and Phase II. A successful Phase II trial would lay the foundation for broad dissemination. Our long term goal for this project is to disseminate the model widely and to develop strategies for addressing the national need. A successful trial would provide support for efforts to 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 our business and significant social benefit.