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

P.L.A.Y. 的随机对照试验

• 批准号: 7924678
• 负责人: RICHARD SOLOMON
• 金额: $ 70.86万
• 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 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7924678
• 关键词: Adaptive Behaviors; Address; Autistic Disorder; Businesses; Centers for Disease Control and Prevention (U.S.); Child; Child Care; Child Development; Child Language; Clinical; Clinical Trials; Cognitive; Communities; Consultations; Controlled Study; Country; Coupled; Data Analyses; Development; Diagnostic; Disease; Educational Intervention; Effectiveness; Effectiveness of Interventions; Emotional; Enrollment; Feasibility Studies; Feedback; Funding; Government; Government Agencies; Grant; Growth; Health education; High Prevalence; Home environment; Home visitation; Hospitals; Hour; House Call; Human Resources; Insurance Carriers; Intervention; Language; Learning; Measures; Methods; Michigan; Modeling; National Research Council; Occupational Therapist; Outcome; Outcome Study; Parents; Pathologist; Pattern; Phase; Phase II Clinical Trials; Pilot Projects; Play; Prevalence; Procedures; Pupil; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Reciprocal Social Interaction; Reporting; Research; Research Design; Research Priority; Research Project Grants; Resources; Sampling; Schools; Services; Severities; Site; Small Business Innovation Research Grant; Social Development; Social Workers; Solutions; Speech; Stress; Structure; System; Testing; Time; Trainers Training; Training; United States National Institutes of Health; Universities; base; brief intervention; care systems; cognitive function; community setting; cost; design; dissemination trial; early childhood; evidence base; group intervention; improved; innovation; interest; pressure; programs; public health relevance; research study; satisfaction; seal; service intervention; social; teacher; training project

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.

描述（由申请人提供）：为自闭症谱系障碍（ASD）儿童开发一种[循证]，具有成本效益和[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。CDC对ASD的最新患病率估计是150名儿童中有1名。据国家研究理事会称，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），而大多数州没有提供这种干预，因为a）全国缺乏训练有素的人员，B）由专业人员提供的这种干预非常昂贵（25 - 60 K美元），c）尚未开发和测试一种基于证据的、易于传播的、具有成本效益的模式，以供全国推广。未满足的国家需求是巨大的。人民解放军项目（自闭症青少年的游戏和语言）家庭咨询模式是一个创新的培训师解决方案，以潜在地解决这一国家的需要。使用格林斯潘的学习/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学习伙伴，费用是专业人员提供密集服务的十分之一（4000美元）。初步临床研究的证据表明，该模型是有前途的。家长们学习了这些方法，干预组的孩子们表现出临床和统计学上的改善。此外，在刚刚完成的I期SBIR对照研究中，2个干预和2个对照研究中心各招募了20名ASD儿童。在与复活节海豹和密歇根州立大学的密切合作下，该赠款成功地试行了执行第二阶段试验所需的程序。对照研究确立了进行更大规模的II期试验的可行性，对照研究的结果尽管数量少，干预时间短，但令人鼓舞。该模型在社区机构、学校和医院等真实的世界环境中的早期传播也已成功完成。第二阶段试验的假设是，ESTA的父母培训干预模式可以显着改善自闭症幼儿的发展结果。一个成功的试验将鼓励私人保险公司和政府机构批准大幅增加自闭症强化干预服务的资金，从而广泛传播这种模式，使自闭症患者的业务大幅增长，并产生重大的社会效益。公共卫生相关性：人民解放军项目培训家长为患有自闭症的幼儿提供强化干预。我们建议进行随机对照临床试验，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照顾自闭症儿童的国家战略。