AutismKinleyETNCT06685822

Expanding Autism Diagnostic Biomarkers to Kenya

A study testing Eyelink Portable Duo in people with Autism, run by Indiana University at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 14 to 72 monthsHealthy volunteers can take part
Conditions the study is for: Autism
What is being tested?: Eyelink Portable Duo
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteKenya
Study dates: 7 Nov 2024to 1 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 72 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Moi Teaching and Referral Hospital
Eldoret

Other trials in Kenya

About this study

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

Read the 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)

Conditions: Autism
Being tested: Eyelink Portable Duo
Medical subject headings: Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06685822
Study group	Role	What they receive
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. Receives: Diagnostic Test: Eyelink Portable Duo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 20241 Jun 2025

First posted13 Nov 2024
Study start7 Nov 2024
Primary completion1 Jun 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AutismStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06685822
Sponsor's protocol ID: 23559
Acronym: KinleyET
Status last verified: Oct 2025
First submitted: 11 Nov 2024
Last updated: 5 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanding Autism Diagnostic Biomarkers to Kenya
ClinicalTrials.gov ID: NCT06685822
Acronym / sponsor ID: KinleyET / 23559
Conditions: Autism
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Purdue University
Study start: 7 Nov 2024 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 13 Nov 2024 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Children participate in eye-tracking activity	Experimental	Diagnostic Test: Eyelink Portable DuoChildren 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.

Who may qualify

Ages: 14 to 72 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eyelink Portable DuoEye-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.	Diagnostic test	Children participate in eye-tracking activity

Primary outcome

Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis
Time frame: Day 1
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.

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Children Participate in Eye-tracking Activity	27	27

Primary outcome: Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Autism n = 16	Non-Autism n = 8
Autism (index test)	13	1
Non-Autism (index test)	3	7

Population analysed: Participants that provided usable eye-tracking data (n=3 did not provide usable data; Autism: n=2; Non-Autism: n=1).

Adverse events

Time frame: 1 Day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Children Participate in Eye-tracking Activity	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brandon Keehn, PhD principal investigator

Purdue University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Eyelink Portable Duo in people with Autism, run by Indiana University at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06685822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.