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，具有成本效益的密集干预措施，用于治疗自闭症谱系障碍（ASD）的幼儿（ASD）是该国和国际上的健康和教育系统的优先事项。 ASD的最新患病率估计范围为4/1000至6.5/1000儿童。此外，即使在ASDS认同的儿童人数增加，在这些方法中，在这些方法中接受培训的人员短缺。 NIH表明，自闭症中的早期干预措施和多站点随机临床试验都是研究和国家科学院报告的高度优先级，强调了强度（25小时/周，1：1或1：2教师：学生：学生比率），参与和全面的干预措施是对自身的高度介入的高度介入，以实质性地依次进行实质性的解决方案。鉴于大多数州通常不会为密集的干预提供广泛的支持，因此未满足的国家需求是巨大的。根据格林斯潘（Greenspan）的理论上框架，我们开发了一种创新的解决方案，以解决这一国家需求。该计划称为“ P.L.A.Y.项目”（自闭症年轻人的游戏和语言），我们有初步的临床证据表明，这种父母培训模型是有效的。该模型的早期传播也已成功地完成了社区机构，学校和医院，从而导致与一个主要的国家合作伙伴Easter Seals建立联盟。现在，我们准备组织一项严格的临床试验。我们的假设是，可以组织一个随机，受控，基于社区的临床试验，以测试父母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，我们提议在密歇根州立大学的指导下试行该程序，该程序将在II阶段进行的完整试验中使用。复活节密封将为第一阶段和第二阶段提供社区地点。成功的II期试验将为广泛传播奠定基础。该项目的长期目标是广泛传播该模型，并制定解决国家需求的策略。一项成功的审判将为鼓励私人保险公司和政府机构批准自闭症强化干预服务的资金大幅增加而提供支持，从而大量传播这种模式，我们的业务巨大增长和巨大的社会利益。