Community-viable screening for ASD in 9-month-old infants using quantitative eye-tracking assays of social visual engagement

项目摘要 该项目是为了响应NIMH RFA-MH-19-120要求开发和验证新的筛选方法， 可用于婴儿期（0-12个月）的自闭症谱系障碍（ASD）方法。我们将部署一个 成本效益高，高通量的方法，利用基于性能，客观，和高度定量的眼睛， 社交视觉参与的跟踪分析--婴儿视觉探索、参与并最终 从周围世界中学习并适应--通过独立的移动的眼动跟踪数据收集系统收集 设备，在我们的实验室创建（马库斯自闭症中心研究设备，MAC-ID）。我们会收集眼睛- 跟踪数据来自一个基于人群的样本，N=2,000个9个月大的婴儿连续招募的初级 在他们9个月的健康儿童访问时进行护理。这些婴儿将从9岁开始纵向随访， 直至26个月，以完成一系列序贯筛选和临床确定程序 旨在最大限度地提高灵敏度，并实现ASD与非ASD的临床医生最佳估计诊断分配。 ASD和受影响[包括ASD和非ASD发育迟缓]与未受影响。我们将测量 9个月时基于眼动追踪的筛查相对于临床医生最佳估计诊断的准确性 24个月（主要分析），我们将在9个月时测量眼动追踪试验之间的尺寸一致性 月相对于社会残疾，语言能力和非语言认知能力（次要）的结果水平 分析）。我们的首要目标是开发高质量、客观、基于性能的工具， 作为筛查ASD和其他可行的发育迟缓的有效和社区可行的手段 在婴儿期，最终促进更好地获得早期干预并从中受益。

PROJECT SUMMARY This project is in response to NIMH RFA-MH-19-120 calling for the development and validation of new screening methods for autism spectrum disorder (ASD) that can be used in infancy (0-12 months of age). We will deploy a cost-effective, high-throughput methodology utilizing performance-based, objective, and highly quantitative eye- tracking assays of social visual engagement—the way in which infants visually explore, engage, and ultimately learn from and adapt to their surrounding world—collected on a standalone, mobile eye-tracking data collection device, created in our lab (the Marcus Autism Center Investigational Device, MAC-ID). We will collect eye- tracking data from a population-based sample of N=2,000 9-month-old infants recruited consecutively in primary care practices at the time of their 9-month well-child visits. These infants will be followed longitudinally from 9 until 26 months for completion of a series of sequential screening and clinical ascertainment procedures designed to maximize sensitivity and achieve clinician-best-estimate diagnostic assignments of ASD vs. non- ASD and Affected [including ASD and non-ASD developmental delays] vs. Unaffected. We will measure the accuracy of eye-tracking-based screening at the age of 9 months relative to clinician best estimate diagnosis at 24 months (primary analysis), and we will measure dimensional agreement between eye-tracking assays at 9 months relative to outcome levels of social disability, verbal ability, and nonverbal cognitive ability (secondary analyses). Our overarching goal is to develop high-quality, objective, performance-based tools that can function as an effective and community-viable means of screening for ASD and other actionable developmental delays in infancy, to ultimately facilitate improved access to and benefit from early intervention.