Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement
This study is looking at a new way to screen for autism spectrum disorder (ASD) and other developmental delays in babies as young as 9 months old. It uses a special device called EarliPoint Investigational Device, which tracks your baby's eye movements while they watch videos of other children playing. The goal is to see if how babies look at social information can help identify developmental differences early. We're looking for 2120 healthy infants between 8 and 10 months old to participate. The study will measure how accurate this eye-tracking method is at 9 months compared to a diagnosis of ASD or developmental delay at 24 months. The current recruitment status is unclear.
- Study design
- This is an observational study, meaning participants will be observed without receiving an experimental treatment. It aims to enroll 2120 infants.
- What's involved
- Your child will have an eye-tracking session at 9 months. You will also complete questionnaires about your child's health and development at 9, 12, 15, 18, 21, and 24 months. If developmental delays are suspected, your child may have an in-person assessment between 18-26 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed until 24 months of age, with potential follow-up assessments between 18-26 months if developmental delays are suspected.
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Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Warren R Jones, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months24 months
Diagnostic performance measured by sensitivity, specificity, area under the receiver operating characteristic curve, positive predictive value, and negative predictive value of the eye-tracking-based assays when compared with clinical reference standard diagnostic outcome of ASD or non-ASD.
- Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months.24 months
Diagnostic performance measured by sensitivity, specificity, area under the receiver operating characteristic curve, positive predictive value, and negative predictive value of the eye-tracking-based assays when compared with clinical reference standard diagnostic outcome of Affected vs. Unaffected.