Expanding Autism Diagnostic Biomarkers to Kenya

Not Applicable

• Conditions: Autism

• Registration Number: NCT06685822
• Lead Sponsor: Indiana University

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. 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 Timeline

• Study Start: 2024-11-07
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Agreement between eye-tracking biomarker score and autism diagnosis	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.

Trial Locations

Locations (1)

Moi Teaching and Referral Hospital; 🇰🇪 Eldoret, Kenya