Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07764822
NCT07764822Not yet recruitingNot Applicable

Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants

Indiana University1 site in 1 country40 target enrollmentStarted: January 4, 2027Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
Number of participants with usable eye-tracking biomarker data
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.

Study Design

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

Eligibility Criteria

Ages
14 Months to 48 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Children born at <37 weeks' gestational age who are 14-48 months old at time of referral
  • •Ambulatory (i.e., cruising, walking)
  • •Without significant visual impairment
  • •Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R/F screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)

Exclusion Criteria

  • •Non-English-speaking participants and families.

Arms & Interventions

Intervention

Experimental

Eye-tracking device

Intervention: Eye-tracking device (Device)

Outcomes

Primary Outcomes

Number of participants with usable eye-tracking biomarker data

Time Frame: Day 1

The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.

Number of participants with suspected autism

Time Frame: Day 1

The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.

Secondary Outcomes

  • Caregiver attitudes towards use of the eye-tracking device(Day 1)
  • Individual and Family Predictors (IFP)(Day 1)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pyone David

Assistant Professor of Clinical Pediatrics

Indiana University

Study Sites (1)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention ProgramAutismAutism Spectrum Disorder
NCT07623759Emory University100
Completed
Not Applicable
Biomarkers for Epilepsy Development and the Effect of Physical Exercise in Children With AutismEpilepsyAutism Spectrum Disorder
NCT07373431Region Skane50
Not yet recruiting
Phase 1
To identify and detect the early signs of autism in children using eye-movement patterns
CTRI/2021/03/031840Department of Science and Technology
Not yet recruiting
Not Applicable
Biomarkers of ASD/ADHD and Factors Affecting Anxiety and Depression in Children and Young AdultsADHD - Attention Deficit Disorder With HyperactivityAutism Spectrum Disorder (ASD)Developmental Coordination Disorder (DCD)
NCT07570381University of Exeter800
Not yet recruiting
Not Applicable
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With AutismAutism Spectrum Disorder (ASD)Autism
NCT07522190Stanford University140