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NCT Number: NCT05916430

Screening for Autism in 9-Month-Olds by Measuring 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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Infant Development Mental Disorders Neurodevelopmental Disorders

Age range

8 month–10 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Screening test

Primary outcomes

  1. Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months

    Time frame: 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.

  2. Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months.

    Time frame: 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.

Secondary outcomes

  1. 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)

    Time frame: 18-26 months

    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.

  2. 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

    Time frame: 18-26 months

    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).

  3. Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of nonverbal cognitive ability at 18-26 months.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

FirstFocus Study

CONTACT

[email protected]

404-785-4529

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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