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

使用移动技术对初级保健早期筛查中发现的自闭症幼儿进行早期社交互动 (ESI) 模型的 3/3 有效性试验

• 批准号: 10452750
• 负责人: Catherine Lord
• 金额: $ 25.12万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-16 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10452750
• 关键词: Adaptive Behaviors; Address; Advisory Committees; Autism Diagnosis; COVID-19 pandemic; Calibration; California; Child; Clinical; Collaborations; Communication; Communities; Cost-Benefit Analysis; Data; Data Pooling; Development; Developmental Disabilities; Diagnosis; Diagnostic; Dissemination and Implementation; Documentation; Early Diagnosis; Early Intervention; Early treatment; Effectiveness; Effectiveness of Interventions; Ensure; Environment; Evaluation; Evidence based intervention; Family; Family Characteristics; Feedback; Florida; Geography; Goals; Growth; Health Services; Health Services Accessibility; Home; Individual; Inequality; Intervention; Knowledge; Lead; Light; Lighting; Link; Los Angeles; Measures; Methods; Midwestern United States; Minority; Modeling; Monitor; Outcome; Outcome Measure; Parents; Pattern; Preventive service; Primary Health Care; Procedures; Randomized; Recording of previous events; Research; Resource-limited setting; Sampling; Screening procedure; Services; Site; Social Interaction; Statistical Data Interpretation; Symptoms; System; Therapeutic; Toddler; Training; Treatment outcome; Universities; Waxes; autism spectrum disorder; autistic children; base; community based care; community based service; compare effectiveness; data management; design; disparity reduction; early screening; education resources; effectiveness trial; ethnic diversity; evidence base; health care disparity; health care service; health disparity; implementation intervention; implementation research; improved; improved outcome; mobile computing; primary outcome; racial and ethnic; recruit; response; rural area; satisfaction; screening; secondary outcome; service intervention; shared decision making; social communication; socioeconomic diversity; socioeconomics; telehealth; tool; treatment as usual; treatment effect; treatment response; uptake; virtual; virtual platform

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.

项目摘要 为了响应RFA-MH-18-700，该协作R01的目标是证明治疗价值和 早期干预（EI）平台的社区范围内实施性，用于自闭症谱系障碍的幼儿 （ASD）这是完全虚拟的，从招聘到干预。这个平台 - 社交互动 移动教练（ESI-MC）通过教练和反馈部署单个远程医疗会议，以帮助家庭 嵌入干预日常活动。具体而言，我们将对ESI-MC进行有效性试验以解决 开始基于证据的干预措施是否会带来更好的结果的重要问题 以后开始。我们将使用修改后的楔形设计并混合来解决这个问题 实施研究以分析ESI-MC获得的数据从18、24或30个月开始。我们将 从360个18个月大的孩子中诊断出240名儿童，具有早期的自闭症迹象，每一个中有60个儿童 美国四个地区（东北，东南，中西部，西海岸）。他们将使用新的虚拟招募 平台 - 我的婴儿导航器 - 链接新的监视和筛选工具，这是一个上传视频记录的应用程序 家庭观察和远程医疗干预课程以及一揽子教育资源。 240 儿童将被随机分配到三个ESI-MC定时组之一。我们将衡量活跃的孩子 作为主要结果变量，参与和社会交流每6个月改变一次。结果 将检查发育水平，自闭症症状和自适应行为的度量以衡量 差异治疗效果。我们将通过研究目的实现这些目标：1。比较 ESI-MC在儿童积极参与的近端结果指标中实施了6个月的有效性， 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个月时与治疗时（TAU）以及（1B）的治疗时序组为18、24， 或30个月。 2。检查（2a）父母交易支持和基于证据的策略的变化 变化的机制和（2b）对治疗反应的个人儿童和家庭特征。 3。比较干预对儿童发育水平的次要结果度量的有效性， 自闭症症状和适应性行为（3a）在24和30个月时与治疗态度（tau）和（3b） 在18、24或30个月的时间内启动的治疗时序组。 4。探索在36个月时的结果，个人 从18-36个月开始的变化模式，以及通过估算的治疗时序组变化的预测指标 儿童成长轨迹。 5。检查影响宽度传播的障碍和促进因素， 种族，社会经济和地理线路之间的实施和可持续性。最大化使用 移动技术，ESI-MC提供了可行的社区可行，可扩展和可持续治疗的前景 改善ASD幼儿的EI服务，尤其是在少数族裔和低资源社区中。