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: 10668446
• 负责人: Catherine Lord
• 金额: $ 35.1万
• 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/10668446
• 关键词: Adaptive Behaviors; Address; Autism Diagnosis; COVID-19 pandemic; Calibration; California; Child; Clinical; Collaborations; Communication; Communities; Cost-Benefit Analysis; Data; Data Pooling; Development; Developmental Disabilities; Diagnosis; Diagnostic; Documentation; Early Diagnosis; Early Intervention; Early identification; Early treatment; Educational process of instructing; Effectiveness; Effectiveness of Interventions; Ensure; Environment; Ethnic Origin; Evaluation; Evidence based intervention; Family; Family Characteristics; Feedback; Florida; Geography; Goals; Growth; Health Services; Health Services Accessibility; Home; Individual; Inequality; Intervention; Knowledge; Light; Lighting; Link; Los Angeles; Manuals; Measures; Methods; Midwestern United States; Minority; Modeling; Monitor; Outcome; Outcome Measure; Parents; Pattern; Primary Care; Procedures; Race; Randomized; Recording of previous events; Research; Resource-limited setting; Sampling; Screening procedure; Services; Site; Social Interaction; Statistical Data Interpretation; Symptoms; System; Therapeutic; Toddler; Training; Transact; Treatment outcome; United States Preventative Services Task Force; Universities; Video Recording; Waxes; access disparities; autism spectrum disorder; autistic children; community based care; community based service; compare effectiveness; data management; design; disparity reduction; early screening; education resources; effectiveness trial; evidence base; health care disparity; health care service; health disparity; implementation intervention; implementation research; improved; improved outcome; mobile computing; primary outcome; recruit; response; rural area; satisfaction; screening; secondary outcome; service intervention; shared decision making; social communication; socioeconomic diversity; socioeconomics; team-based care; 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