NCT05916430

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,120 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 8 Months – 10 Months
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to see if measuring how infants look at social information can be used as a screening tool to identify developmental delays or vulnerabilities in infants as young as 9 months of age. What the 9-month-old infant looks at will be measured with eye-tracking technology, which uses a video camera to safely measure the child's eye movements while the child watches video scenes of other children at play. Parents/caregivers will be asked if they would like to participate during their child's 9-month well-baby visit at their pediatrician's office. If they agree to participate, the child will have their first study visit at this time. Children will undergo an eye-tracking session to measure social looking. Parents/caregivers will also complete forms and questionnaires about their child's health and development. The forms will be emailed, to be completed when the child is approximately 9, 12, 15, 18, 21, and 24 months old. If a child shows signs of developmental delay (DD) or autism spectrum disorder (ASD), the child will be asked to participate in a comprehensive developmental and diagnostic assessment in-person with expert clinicians when the child is between 18-26 months old, to determine the child's strengths and any vulnerabilities, and to recommend any support or treatment if needed. If the child does not show signs of developmental delay and/or autism, the investigators may still invite the child for an in-person assessment with expert clinicians when the child is between 18-26 months old. Approximately 10% of children who do not show any signs of developmental delay and/or autism will be randomly selected for an in-person assessment. At the end of the assessment, parents/caregivers will be provided feedback on their child's strengths and any vulnerabilities and, if necessary, a report will be written to help them access services for their child.

Conditions

• Autism
• Infant Development

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-02
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2023-06-23
• Last updated: 2025-09-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study