Expanding Autism Diagnostic Biomarkers… | Clinical Trial

Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

14 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moi Teaching and Referral Hospital

Eldoret, Kenya

About this study

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. The investigators will recruit children from Moi Teaching and Referral Hospital (MTRH; Eldoret, Kenya) previously enrolled in the Health Equity Advancing through Learning Health Systems Research (HEAL-R) Autism at MTRH study (IREC/664/2023, approval number 0004633)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children enrolled in the HEAL-R Autism at MTRH study
Children ages 14-72 months
Caregivers of children must speak Kiswahili (local language) or English.

Exclusion criteria

Children not enrolled in the HEAL-R Autism at MTRH study
Children younger than 14 months or older than 72 months
Caregivers of children do not speak Kiswahili (local language) or English.

Treatment and study plan

Eyelink Portable Duo

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 the lap of the caregiver and will face a computer monitor. After a sticker is applied to the forehead of the child 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 outcomes

Agreement between eye-tracking biomarker score and autism diagnosis

Time frame: Day 1

Group (autism presence/absence) differences in the composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices, will be tested to determine whether this metric is predictive of autism diagnosis. Clinical diagnosis was obtained based upon a standardized clinical evaluation in the parent study. The evaluation included: 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. Eye-tracking biomarkers will be recorded during a brief one-time research visit.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

Purdue University

Registry information

Acronym: KinleyET

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 13, 2024
Registry last updated: Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed