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

This study is looking at a new way to screen for autism spectrum disorder (ASD) and other developmental delays in babies as young as 9 months old. It uses a special device called EarliPoint Investigational Device, which tracks your baby's eye movements while they watch videos of other children playing. The goal is to see if how babies look at social information can help identify developmental differences early. We're looking for 2120 healthy infants between 8 and 10 months old to participate. The study will measure how accurate this eye-tracking method is at 9 months compared to a diagnosis of ASD or developmental delay at 24 months. The current recruitment status is unclear.

Study design
This is an observational study, meaning participants will be observed without receiving an experimental treatment. It aims to enroll 2120 infants.
What's involved
Your child will have an eye-tracking session at 9 months. You will also complete questionnaires about your child's health and development at 9, 12, 15, 18, 21, and 24 months. If developmental delays are suspected, your child may have an in-person assessment between 18-26 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until 24 months of age, with potential follow-up assessments between 18-26 months if developmental delays are suspected.

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NCT05916430

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

Recruiting
Not specifiedAges 8–10Observational
Emory University
~2,120 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:EarliPoint Investigational Device

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months
Measured over 24 months
+1 more outcome measured
Autism
Infant Development
2 sites across 1 states
Georgia2
  • Warren R Jones, PhD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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.
  • Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months24 months

    Diagnostic performance measured by sensitivity, specificity, area under the receiver operating characteristic curve, positive predictive value, and negative predictive value of the eye-tracking-based assays when compared with clinical reference standard diagnostic outcome of ASD or non-ASD.

  • Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months.24 months

    Diagnostic performance measured by sensitivity, specificity, area under the receiver operating characteristic curve, positive predictive value, and negative predictive value of the eye-tracking-based assays when compared with clinical reference standard diagnostic outcome of Affected vs. Unaffected.