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

NCT05916430 | Recruiting DMC FDA Device

• 3 other identifiers: IRB001150225R01MH121363-032025P013120
• Study Type: observational
• Target: 2,120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Autism; Infant Development

Keywords

Screening; well-baby visits; Social Development; Communicative Development; Development Disabilities; Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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)

  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

  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.

  18-26 months

Study Arms (1)

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

Interventions

EarliPoint Investigational Device DIAGNOSTIC_TEST

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.

Also known as: Screening test

General Population Screening Cohort

Eligibility Criteria

• Age: 8 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Early Detection of Cancer

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Early Diagnosis; Diagnosis

Study Officials

• Warren R Jones, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FirstFocus Study

CONTACT

404-785-4529; FirstFocus@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: February 2, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Access will follow standard NIMH NDA processes, as detailed on the website: https://nda.nih.gov/nda/faq.html

Locations

US (2)