The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya

ConditionAutism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-72
SponsorIndiana University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

850 Participants
are divided into 1 treatment group
Group A: Children Undergoing Developmental Evaluation for AutismExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator