Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT06471504

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 1 - 4

Healthy Volunteers: Not accepted

Interventions

Eyelink Portable Duo

Study Details

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.

Conditions

Autism

Study ID

NCT06471504

Start date

Jan 8, 2025

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 4

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Agreement between eye-tracking biomarker score and diagnosis [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Rebecca McNally Keehn, PhD, HSPP

317-278-3435mcnallyr@iu.edu

Angela R Paxton, BS

317-278-3435arpaxton@iu.edu

Locations

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-04-22.