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Eye Tracking for Autism Risk Detection in Young Children

This study is looking at whether a special eye-tracking system called Eyelink Portable Duo can help identify the risk of autism in young children. The Eyelink Portable Duo is a non-invasive (no needles or surgery) device that measures how your child's eyes move and their pupil size while they look at pictures and movies. We are looking for children aged 12 to 48 months who have appointments at Riley Hospital for Children at Indiana University Health clinics. Your child's caregiver must speak English or Spanish and be able to give consent. The main goal is to see how well the eye-tracking measurements match up with an autism diagnosis. The current status of this study is unclear.

Study design
This interventional study plans to enroll 100 participants. It is not specified if it is randomized or blinded.
What's involved
Your child would have a short session, less than 15 minutes, where their eye movements and pupil diameter are measured while they view pictures and movies.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, agreement between eye-tracking score and diagnosis, is measured on Day 1.

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NCT06471504

Use of Eye Tracking to Aid in Autism Risk Detection

Recruiting
NAAges 12–48InterventionalDiagnostic
Indiana University
~100 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Eyelink Portable Duo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Agreement between eye-tracking biomarker score and diagnosis
Measured over Day 1

Conditions

Autism

Explore related trials

Autism

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Rebecca R McNally Keehn, PhD, HSPP · PRINCIPAL_INVESTIGATOR · IU School of Medicine

Who to contact

Rebecca McNally Keehn, PhD, HSPP
[email protected]
317-278-3435
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Agreement between eye-tracking biomarker score and diagnosisDay 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.