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

P.L.A.Y. 对照试验的试点研究

• 批准号: 7155629
• 负责人: RICHARD SOLOMON
• 金额: $ 27.46万
• 依托单位: RICHARD SOLOMON MD, PLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-22 至 2008-09-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7155629
• 关键词: autism; behavioral /social science research tag; child psychology; clinical research; clinical trials; community mental health services; health care model; health care personnel education; health care service evaluation; health services research tag; human subject; information dissemination; medical outreach /case finding; middle childhood (6-11); parent offspring interaction; patient oriented research; play; preschool child (1-5); psychotherapy; student health services; therapy design /development

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.

描述（由申请人提供）：开发可复制的、具有成本效益的强化干预措施来治疗患有自闭症谱系障碍（ASD）的幼儿，是该国和国际卫生和教育系统的优先事项。最近估计 ASD 患病率范围为 4/1000 至 6.5/1000 名儿童。此外，尽管确诊患有自闭症谱系障碍的儿童数量不断增加，但全国范围内接受过这些方法培训的人员仍然短缺。美国国立卫生研究院 (NIH) 表示，自闭症的早期干预和多中心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强化（每周 25 小时，师生比为 1:1 或 1:2），吸引学生参与综合干预措施 自闭症儿童患病率高，加上需要加强干预，这意味着需要大量资源来有效解决自闭症问题。鉴于大多数州通常不会为强化干预措施提供广泛支持，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解决方案，以帮助满足这一国家需求。这个项目被称为“The P.L.A.Y. Project”（自闭症青少年的游戏和语言），我们有初步的临床证据表明这种家长培训模式是有效的。该模型已成功地早期传播到社区机构、学校和医院，并与主要的全国合作伙伴复活节海豹队建立了联盟。现在我们准备组织一项严格的临床试验。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来测试家长培训干预模型是否可以改善自闭症幼儿的功能结果。在第一阶段，我们建议在密歇根州立大学的指导下试点该程序，以用于第二阶段进行的全面试验。 Easter Seals 将为一期和二期提供社区用地。第二阶段试验的成功将为广泛传播奠定基础。我们该项目的长期目标是广泛传播该模型并制定满足国家需求的战略。一次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自闭症强化干预服务资金的努力提供支持，从而导致该模式的广泛传播，我们的业务大幅增长和显着的社会效益。