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RECRUITING
NCT05916430

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

Sponsor: Emory University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Months - 10 Months

Study Type

OBSERVATIONAL

Enrollment

2120

Start Date

2023-02-02

Completion Date

2027-12

Last Updated

2025-09-22

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

EarliPoint 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.

Locations (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States