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 作为对RFA-MH-18-700的回应，该合作R 01的目标是证明治疗价值， 自闭症谱系障碍幼儿早期干预（EI）平台在社区范围内的可实施性 (ASD)这是完全虚拟的，从招募到干预。本平台-早期社交互动 移动的指导（ESI-MC）部署个人远程医疗会话，并提供指导和反馈，以帮助家庭 将干预纳入日常活动。具体而言，我们会进行一项ESI-MC的成效试验， 更早开始循证干预是否会导致更好的结果， 稍后开始。我们将通过使用改进的阶梯式楔形设计和混合式楔形设计来解决这个问题。 在18个月、24个月或30个月时开始对ESI-MC获得数据进行分析的实施研究。我们将 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， 美国四个地区（东北部、东南部、中西部、西海岸）。他们将使用新的虚拟 平台-我的宝贝导航-链接一个新的监视和筛选工具，一个应用程序上传视频记录 家庭观察和远程保健干预会议，以及一揽子教育资源。的240 儿童将被随机分配到三个ESI-MC计时组之一。我们将测量儿童活动 参与度和社会沟通作为主要结果变量每6个月发生变化。结果 发展水平，自闭症症状和适应行为的措施将被检查，以衡量 差别待遇效应。我们将通过研究实现这些目标AIMS：1.比较 ESI-MC实施6个月对儿童主动参与的近端结果测量的有效性， 儿童社会沟通变化，父母交易支持和父母基于证据的策略使用（1A） 在24和30个月时进行按剂量治疗（TAU），以及（1B）在18，24， 或者30个月2.检查（2A）母公司交易支持和循证策略使用的变化， 改变机制和（2B）对治疗反应适度的个别儿童和家庭特征。 3.比较两组儿童发育水平的次级指标干预效果， 24个月和30个月时的自闭症症状和适应行为（3A）与常规治疗（TAU）以及（3B） 在18、24或30个月开始的治疗时间组中。4.探索36个月时的结局，个体 18-36个月的变化模式，以及通过估计治疗时间组的变化预测因素 儿童成长轨迹5.审查影响广泛传播的障碍和促进因素， 在种族、社会经济和地理界限上的执行和可持续性。最大限度地利用 移动的技术，ESI-MC提供了一个社区可行的，可扩展的和可持续的治疗前景， 改善对自闭症幼儿的教育服务，特别是在少数民族和低资源社区。

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.