Use of Eye Tracking to Aid in Autism Risk Detection

NCT ID: NCT06471504

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Autism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Children Undergoing Developmental Evaluation

Children undergoing a standard of care developmental evaluation will be enrolled into the study. After the completion of the developmental evaluation, research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements are tracked and recorded.

Group Type EXPERIMENTAL

Eyelink Portable Duo

Intervention Type 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.

Interventions

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Eyelink 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca McNally Keehn

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca R McNally Keehn, PhD, HSPP

Role: PRINCIPAL_INVESTIGATOR

IU School of Medicine

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca McNally Keehn, PhD, HSPP

Role: CONTACT

Phone: 317-278-3435

Email: [email protected]

Angela R Paxton, BS

Role: CONTACT

Phone: 317-278-3435

Email: [email protected]

Facility Contacts

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Rebeccca McNally Keehn, PhD, HSPP

Role: primary

Other Identifiers

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21697

Identifier Type: -

Identifier Source: org_study_id