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NCT Number: NCT06471504

Use of Eye Tracking to Aid in Autism Risk Detection

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

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Key information

Conditions

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

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Rebeccca McNally Keehn, PhD, HSPP

CONTACT

About this study

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children ages 12-48 months. We will recruit children from Riley Hospital for Children at Indiana University Health clinics to determine whether these measures may help determine autism risk.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Young children ages 12-48 months scheduled for health care visits at Riley Hospital for Children at Indiana University Health clinics (e.g., Pediatric Care Center clinics).
  • Children must have English- or Spanish-speaking caregivers.
  • Children must have a legal guardian that is able to provide consent.

Exclusion criteria

  • Child is younger than 12 months or older than 48 months.
  • Child's caregiver(s) is not English- or Spanish-speaking.

Treatment and study plan

Eyelink Portable Duo

Diagnostic Test

Eye-tracking data will be collected using a commercially-available remote eye-tracking system (Eyelink Portable Duo). Eye movements and pupil diameter will be collected while participants view a series of developmentally appropriate pictures and movies. The eye-tracker consists of two cameras; one that monitors eye movements and a second scene camera that monitors head movements, which permits eye tracking to take place without any equipment touching the child. Children will be asked to sit in highchair or on their caregiver's lap and will face a computer monitor. After a sticker is applied to the child's forehead and brief eye-movement calibration completed, next visual stimuli (i.e., pictures and videos) will be presented on a laptop computer monitor that is placed at approximately 60-80cm from the child. The eye tracking portion of the visit will last approximately 15 minutes or until the child is no longer able to attend to pictures/videos.

Primary outcomes

  1. Agreement between eye-tracking biomarker score and diagnosis

    Time frame: Day 1

    The composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices that predict autism outcome, will be compared to the categorical autism diagnosis (autism presence/absence). Clinical diagnosis is obtained based upon a standard clinical evaluation conducted by an expert clinical psychologist. The evaluation will include 1) a semi-structured caregiver(s) clinical interview to gather information about developmental history and autism symptoms and 2) a battery of standardized child clinical observational measures. The evaluation will be conducted over a one-time 2-hour clinical autism evaluation. Eye-tracking will be recorded immediately following the clinical evaluation for a period of up to 15 minutes.

Study contacts

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

Angela R Paxton, BS

CONTACT

[email protected]

317-278-3435

Rebecca McNally Keehn, PhD, HSPP

CONTACT

[email protected]

317-278-3435

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: RCFET

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2024
Registry last updated
Apr 22, 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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