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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism; Infant Development
• Intervention / Treatment: Diagnostic test: EarliPoint Investigational Device

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.

• Study Type: Observational
• Enrollment (Estimated): 2120

Contacts and Locations

• Study Contact: Name: FirstFocus Study; Phone Number: 404-785-4529; Email: FirstFocus@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory University
      • Contact: FirstFocus Study; Phone Number: 404-785-4529; Email: FirstFocus@emory.edu
      • Contact: Cheryl Klaiman, PhD; Phone Number: 404-785-9387; Email: cklaima@emory.edu
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Children's Healthcare of Atlanta
      • Contact: FirstFocus Study; Phone Number: 404-785-4529; Email: FirstFocus@emory.edu
      • Contact: Cheryl Klaiman, PhD; Phone Number: 404-785-9387; Email: cklaima@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Infants presenting for a 9-month well-child visit between the chronological ages of 8-10 months with no acute illnesses

Description

Inclusion Criteria:

• 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 Criteria:

- 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

General Population Screening Cohort; A general population cohort of 9-month-old infants presenting for well-child visits will be screened initially at 9 months of age, and then screened again sequentially at 12, 15, 18, 21, and 24 months, to test screening performance relative to outcome status with autism or developmental disabilities.

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.; Other Names: Screening test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 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 ASD or non-ASD.	24 months
Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of social disability at 18-26 months compared to the Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2)	Eye-tracking assays at 9 months will generate a social disability index; investigators will measure the correlation between that index and results on a standardized assessment by the ADOS-2 of autistic social disability conducted by expert clinicians at 18-26 months.	18-26 months
Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of verbal ability at 18-26 months compared to the Mullen Scales of Early Learning	Eye-tracking assays at 9 months will generate verbal ability indices; investigators will measure the correlation between those indices and results from a standardized assessment of expressive and receptive language function (the Mullen Scales of Early Learning). Receptive Language and Expressive Language Scales of the Mullen Scales of Early Learning (standardized measures of language function). Each item within these scales is scored either from 0 to 5 points for certain items or as 0 (skill not demonstrated) or 1 (correct response) for others. Raw scores are calculated by summing item-level ratings from the basal to the ceiling item. These raw scores are converted to standardized T-scores for analysis and interpretation (range: approximately 20-80 T-score; mean = 50, SD = 10; higher scores = better performance). The MSEL also yields an Early Learning Composite (mean = 100, SD = 15; higher scores = better overall performance).	18-26 months
Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of nonverbal cognitive ability at 18-26 months.	Eye-tracking assays at 9 months will generate nonverbal ability indices. Investigators will assess the correlation between those indices and results from the Visual Reception Scale of the Mullen Scales of Early Learning (a standardized measure of nonverbal cognitive function). Each item on the Visual Reception Scale is scored either from 0 to 5 points for certain items or as 0 (skill not demonstrated) or 1 (correct response) for others. Raw scores are calculated by summing item-level ratings from the basal to the ceiling item. These raw scores are converted to standardized T-scores for analysis and interpretation (range: approximately 20-80 T-score; mean = 50, SD = 10; higher scores = better performance).	18-26 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Warren R Jones, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Screening; Autism Spectrum Disorders; well-baby visits; Social Development; Communicative Development; Development Disabilities
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Diagnosis; Early Diagnosis; Early Detection of Cancer
• Other Study ID Numbers: IRB00115022; 5R01MH121363-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are planned to be publicly reposited in the NIMH Data Archive (https://nda.nih.gov) after publication, with accession number added when available.
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Access will follow standard NIMH NDA processes, as detailed on the website: https://nda.nih.gov/nda/faq.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No