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Use of Eye Tracking to Aid in Autism Risk Detection

Use of Eye Tracking to Aid in Autism Risk Detection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06471504
Acronym
RCFET
Enrollment
100
Registered
2024-06-24
Start date
2025-01-08
Completion date
2027-04-30
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTEyelink Portable Duo

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.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Agreement between eye-tracking biomarker score and diagnosisDay 1The 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.

Countries

United States

Contacts

CONTACTRebecca McNally Keehn, PhD, HSPP
mcnallyr@iu.edu317-278-3435
CONTACTAngela R Paxton, BS
arpaxton@iu.edu317-278-3435
PRINCIPAL_INVESTIGATORRebecca R McNally Keehn, PhD, HSPP

IU School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026