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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05916430
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Months - 10 Months
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Feb 2, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
2,120 participants (estimated)

Arms

  • Arm: 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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30322
FirstFocus Study
[email protected]
404-785-4529
Cheryl Klaiman, PhD
[email protected]
404-785-9387
Emory UniversityAtlantaGeorgia30329
FirstFocus Study
[email protected]
404-785-4529
Cheryl Klaiman, PhD
[email protected]
404-785-9387

Find similar trials in Atlanta, GA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Children's Healthcare of Atlanta· Atlanta, GAEmory University· Atlanta, GA

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