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

Emory University

Status: Enrolling

Conditions: Infant Development; Autism

Treatments: Diagnostic Test: EarliPoint Investigational Device

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05916430

5R01MH121363-03 (U.S. NIH Grant/Contract)

IRB00115022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,120 estimated patients

Sex: All

Ages: 8 to 10 months old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

2,120 participants in 1 patient group

General Population Screening Cohort

Description:

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.

Treatment:

Diagnostic Test: EarliPoint Investigational Device