Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT05916430

Conditions

Autism

Infant Development

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

EarliPoint Investigational Device

Study Details

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

Study ID

NCT05916430

Start date

Feb 2, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

2120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months [ Time Frame: 24 months ]
  • Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

FirstFocus Study

404-785-4529FirstFocus@emory.edu

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

FirstFocus Study

404-785-4529FirstFocus@emory.edu

Cheryl Klaiman, PhD

404-785-9387cklaima@emory.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

FirstFocus Study

404-785-4529FirstFocus@emory.edu

Cheryl Klaiman, PhD

404-785-9387cklaima@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-04.