Expanding Autism Diagnostic Biomarkers to Kenya

Indiana University27 enrolled

Overview

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Autism

Interventions

Eyelink Portable DuoDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 14 MonthsMax age: 72 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

Outcomes

Primary Outcomes

Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis

Group (autism presence/absence) differences in the eye-tracking biomarker 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 biomarker will be recorded during a brief one-time research visit. Biomarker (% looking time in non-social region) on a scale for 0 to 100, with greater values reflecting increased attention to non-social information. Cutoff of 40% is used to determine autism likelihood.

Time frame: Day 1

Data from ClinicalTrials.gov

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