RecruitingNCT05916430

Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement

Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement

Sponsor

Emory University

Enrollment

2,120 participants

Start Date

Feb 2, 2023

Study Type

OBSERVATIONAL

Conditions

Autism Infant Development

Summary

The goal of this project is to 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 delays.

Eligibility

Min Age: 8 MonthsMax Age: 10 Months

Inclusion Criteria3

Infants between the chronological ages of 8-10 months
Infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision)
Participants' parents/caregivers must be able to understand and voluntarily provide written informed consent.

Exclusion Criteria1

\- Children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).

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Interventions

DIAGNOSTIC_TESTEarliPoint Investigational Device

Infants will complete eye-tracking data collection at the age of 9 months on the EarliPoint Investigational Device. Eye-tracking video cameras will safely measure the movements of the child's eyes while they watch age-appropriate video scenes of other children playing together. Parents/Caregivers will complete screening forms and questionnaires about their baby's health and development. Parents/caregivers will complete surveys about their child's development. The surveys will be emailed, to be completed when the child is approximately 9, 12, 15, 18, 21, and 24 months old. If the child shows signs of developmental delay, the child will be asked to participate in a comprehensive developmental and diagnostic assessment.