3/3-Effectiveness Trial of the Early Social Interaction (ESI) Model using Mobile Technology for Toddlers with Autism Identified from Early Screening in Primary Care

项目摘要 响应RFA-MH-18-700，此协作R01的目标是展示其治疗价值和 自闭症谱系障碍幼儿早期干预(EI)平台的社区可实施性 (ASD)这完全是虚拟的，从招募到干预。这个平台-早期社交 移动指导(ESI-MC)部署具有指导和反馈的个人远程保健会话，以帮助家庭 在日常活动中嵌入干预措施。具体地说，我们将进行ESI-MC的有效性试验，以解决 重要的问题是，更早开始循证干预是否会带来比 晚些时候开始。我们将通过使用改进的阶梯形楔形设计和混合来解决这个问题 从18个月、24个月或30个月开始进行实施研究，以分析使用ESI-MC获得的数据。我们会 从360名18个月大的儿童中诊断出240名有自闭症早期症状的儿童，每名儿童中有60名 美国四个地区(东北部、东南部、中西部、西海岸)。他们将被招募使用一个新的虚拟 平台-My Baby Navigator-链接新的监控和筛选工具，上传视频记录的应用程序 家庭观察和远程健康干预课程，以及一系列教育资源。240 儿童将被随机分配到三个ESI-MC计时组中的一个。我们将测量儿童的活跃度 参与度和社交沟通作为主要结果变量每6个月改变一次。结果 将检查发育水平、自闭症症状和适应行为的测量，以测量 辨证施治效果。我们将通过研究目标实现这些目标：1.比较 实施6个月的ESI-MC对儿童主动参与的近期结果测量的有效性 儿童社交改变、父母交易支持和父母循证策略使用(1) 在24个月和30个月进行照常治疗(TAU)，以及(1B)在18，24， 或者30个月。2.检查(2A)母公司交易支持和基于证据的策略使用的变化 改变机制和(2B)对治疗反应适中的儿童个人和家庭特征。 3.比较干预措施对儿童发展水平次要结果测量的效果。 自闭症症状和适应行为(3A)与照常治疗(TAU)在24个月和30个月和(3B) 在18个月、24个月或30个月开始进行治疗计时组。4.探索36个月后的结果，个人 18-36个月的变化模式，以及通过估计治疗时间组变化的预测因素 儿童成长轨迹。5.审查影响广泛传播的障碍和促进因素； 跨种族、社会经济和地理界线的执行和可持续性。最大限度地利用 移动技术，ESI-MC提供了一种社区-可行、可扩展和可持续的治疗方法 改善对患有自闭症的幼儿的精神卫生服务，特别是在少数族裔和低资源社区。

PROJECT ABSTRACT In response to RFA-MH-18-700, the goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform—Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, we will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. We will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. We will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 60 in each of four US regions (Northeast, Southeast, Midwest, West Coast). They will be recruited using a new virtual platform—My Baby Navigator—linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. We will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. We will achieve these objectives through research AIMS: 1. Compare the effectiveness of ESI-MC implemented for 6 months on proximal outcome measures of child active engagement, child social communication change, parent transactional supports, and parent evidence-based strategy use (1A) with Treatment-as-Usual (TAU) at 24 and 30 months and (1B) across treatment timing groups initiated at 18, 24, or 30 months. 2. Examine (2A) change in parent transactional supports and evidence-based strategy use as the mechanism for change and (2B) individual child and family characteristics that moderate response to treatment. 3. Compare the effectiveness of intervention on secondary outcome measures of child developmental level, autism symptoms, and adaptive behavior (3A) with Treatment-as-Usual (TAU) at 24 and 30 months and (3B) across treatment timing groups initiated at 18, 24, or 30 months. 4. Explore outcomes at 36 months, individual patterns of change from 18-36 months, and predictors of change across treatment timing groups by estimating child growth trajectories. 5. Examine barriers and promotive factors impacting widespread dissemination, implementation and sustainability across racial, socioeconomic and geographic lines. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.