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）：针对自闭症谱系障碍儿童（ASD）的[基于证据]的开发，具有成本效益和[易于传播]的强化干预形式是该国的健康和教育系统的主要优先事项。 CDC的最新患病率估计是150名儿童中有1个。根据国家研究委员会的说法，这些孩子需要进行密集的干预措施（25小时，1：1或1：2老师与学生比率），大多数州无法提供，因为a）a）训练有素的人员短缺，b）专业人士提供的干预措施是非常昂贵的（25-60k），并且是循证的（25-60k）和C），并且是基于循证的，尚未发行的，尚未发行，并且尚未发行，并且尚未发行过既富裕的模型又尚未发行。未满足的国家需求是巨大的。 P.L.A.Y.项目（自闭症年轻人的游戏和语言）家庭咨询模型（PLAY）是一种创新的火车培训解决方案，可以解决这一国家需求。使用Greenspan的DIR/Developmental Framework，以及一种结构性的教育方法，包括视频反馈，家庭顾问培训父母如何成为孩子的最佳游戏合作伙伴的成本（4,000美元），这是专业人士提供密集服务的成本（$ 4K）。试点研究的初步临床证据表明该模型是有希望的。父母了解了这些方法的发挥，干预组中的孩子表现出临床和统计改善。此外，在刚刚完成的I期SBIR对照研究中，有2个干预和2个控制地点每个招募了20名ASD儿童。与复活节密封和密歇根州立大学密切合作，该赠款成功地试行了执行II期审判所需的程序。对照研究确定了进行更大的II期试验和对照研究结果的可行性，尽管数量少，而且简短的干预仍令人鼓舞。该模型的早期传播也已成功完成了社区机构，学校和医院的现实环境。第二阶段试验的假设是，Play的父母训练干预模型可以显着改善自闭症幼儿的发育效果。一项成功的审判将鼓励私人保险公司和政府机构批准自闭症密集干预服务的资金大幅增加，从而广泛传播了这种模式，Play的业务实质上增长以及巨大的社会利益。公共卫生相关性：P.L.A.Y.项目训练父母为自闭症患者提供密集干预。我们建议进行一项随机对照临床试验，以证明这种干预模型在社区环境中的有效性。一项成功的研究可能会影响国家照顾自闭症儿童的国家战略。