Expanding Autism Diagnostic Biomarkers to Kenya

NCT06685822 | Completed Results FDA Device

• 1 other identifier: 23559
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Study Arms (1)

Children participate in eye-tracking activity

EXPERIMENTAL

Children enrolled in the HEAL-R Autism at MTRH study will be enrolled into the study. Research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements and pupil diameter are tracked and recorded.

Diagnostic Test: Eyelink Portable Duo

Interventions

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.

Children participate in eye-tracking activity

Eligibility Criteria

• Age: 14 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The sample for the current study is small and has both selection and referral biases. Further, a class imbalance was present; such an imbalance has the potential to overinflate accuracy metrics. For all these reasons our findings should be interpreted with caution.

Results Point of Contact

• Title: Dr. Rebecca McNally Keehn
• Organization: Indiana University School of Medicine

mcnallyr@iu.edu

(317) 274-2121

Study Officials

• Brandon Keehn, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: November 7, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 5, 2026
• Results First Posted: August 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)