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Clinical Trials/NCT06685822
NCT06685822
Completed
Not Applicable

Expanding Autism Diagnostic Biomarkers to Kenya

Indiana University1 site in 1 country27 target enrollmentNovember 7, 2024
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Indiana University
Enrollment
27
Locations
1
Primary Endpoint
Agreement between eye-tracking biomarker score and autism diagnosis
Status
Completed
Last Updated
6 months ago

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. 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)

Registry
clinicaltrials.gov
Start Date
November 7, 2024
End Date
August 1, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca McNally Keehn

Assistant Professor of Pediatrics

Indiana University

Eligibility Criteria

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.

Outcomes

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.

Study Sites (1)

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