Trial Outcomes & Findings for Expanding Autism Diagnostic Biomarkers to Kenya (NCT NCT06685822)
NCT ID: NCT06685822
Last Updated: 2026-08-05
Results Overview
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.
COMPLETED
NA
27 participants
Day 1
2026-08-05
Participant Flow
We will recruit children enrolled in HEAL-R study to the study between November 2024 and April 2025. Aligned with previous inclusion criteria, we will recruit and test young children, ages 14-72 months, with increased likelihood for autism and children without autism.
Participant milestones
| Measure |
Children Participate in Eye-tracking Activity
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.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Expanding Autism Diagnostic Biomarkers to Kenya
Baseline characteristics by cohort
| Measure |
Children Participate in Eye-tracking Activity
n=27 Participants
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.
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|---|---|
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Age, Continuous
|
4.57 years
STANDARD_DEVIATION 0.81 • n=20 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
Kenya
|
27 participants
n=20 Participants
|
|
Eye-tracking Biomarker
|
42.84 % looking time
STANDARD_DEVIATION 19.79 • n=20 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Participants that provided usable eye-tracking data (n=3 did not provide usable data; Autism: n=2; Non-Autism: n=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.
Outcome measures
| Measure |
Autism
n=16 Participants
Child evaluated an diagnosed with autism (based on parent study)
|
Non-Autism
n=8 Participants
Child evaluated and diagnosed with a non-autism condition (e.g., developmental delay; based on parent study)
|
|---|---|---|
|
Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis
Autism (index test)
|
13 Participants
|
1 Participants
|
|
Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis
Non-Autism (index test)
|
3 Participants
|
7 Participants
|
Adverse Events
Children Participate in Eye-tracking Activity
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca McNally Keehn
Indiana University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place