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.
In this project, we will measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable developmental delays. We will recruit a large cohort of infants from primary care pediatric practices and follow them longitudinally for clinical ascertainment at outcome. Our goal is to develop a community-viable methodology for early ASD screening, thus affording at-risk and affected children with the opportunity to access, and benefit from, early intervention services during periods of maximal neuroplasticity.
