About this trial
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children enrolled in the Tabiri study (R01HD104552)
CHEU or CHUU
Children ages 24-72 months
Caregivers of children must speak Kiswahili (local language) or English.
Disqualifiers
There will be no specific exclusion criteria. We anticipate that a small number of CHEU and CHUU will develop HIV prior to enrollment in the current study; these children will be included and will follow all general study procedures.
Trial design
Single group
Treatments tested in this trial
Eyelink Portable Duo
Diagnostic testEye-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.
Treatment groups
Trial outcomes
Primary outcomes
Agreement between eye-tracking biomarker score and autism diagnosis
The composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices that predict autism outcome, will be compared to the categorical autism diagnosis (autism presence/absence). Clinical diagnosis is obtained based upon a standard clinical evaluation. The evaluation will include 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. The evaluation will be conducted over a one-time 2- to 3-hour clinical autism evaluation. Eye-tracking will be recorded immediately following the clinical evaluation.
Sponsors and contacts
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Indiana University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator