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Clinical Trials/NCT06471504
NCT06471504RecruitingNot Applicable

Use of Eye Tracking to Aid in Autism Risk Detection

Indiana University2 sites in 1 country100 target enrollmentStarted: January 8, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
Agreement between eye-tracking biomarker score and diagnosis

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
12 Months to 48 Months (Child)
Sex
All
Accepts 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.

Arms & Interventions

Children Undergoing Developmental Evaluation

Experimental

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.

Intervention: Eyelink Portable Duo (Diagnostic Test)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebecca McNally Keehn

Assistant Professor of Pediatrics

Indiana University

Study Sites (2)

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