Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement

Study Overview
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Brief Summary
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The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.

Detailed Description
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The purpose of this study is to see if measuring how infants look at social information can be used as a screening tool to identify developmental delays or vulnerabilities in infants as young as 9 months of age. What the 9-month-old infant looks at will be measured with eye-tracking technology, which uses a video camera to safely measure the child's eye movements while the child watches video scenes of other children at play. Parents/caregivers will be asked if they would like to participate during their child's 9-month well-baby visit at their pediatrician's office. If they agree to participate, the child will have their first study visit at this time. Children will undergo an eye-tracking session to measure social looking. Parents/caregivers will also complete forms and questionnaires about their child's health and development. The forms will be emailed, to be completed when the child is approximately 9, 12, 15, 18, 21, and 24 months old. If a child shows signs of developmental delay (DD) or autism spectrum disorder (ASD), the child will be asked to participate in a comprehensive developmental and diagnostic assessment in-person with expert clinicians when the child is between 18-26 months old, to determine the child's strengths and any vulnerabilities, and to recommend any support or treatment if needed. If the child does not show signs of developmental delay and/or autism, the investigators may still invite the child for an in-person assessment with expert clinicians when the child is between 18-26 months old. Approximately 10% of children who do not show any signs of developmental delay and/or autism will be randomly selected for an in-person assessment. At the end of the assessment, parents/caregivers will be provided feedback on their child's strengths and any vulnerabilities and, if necessary, a report will be written to help them access services for their child.

Official Title
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Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement

Conditions
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Autism, Infant Development

Intervention / Treatment
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* Diagnostic Test: EarliPoint Investigational Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants between the chronological ages of 8-10 months; Infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision); participants' parents/caregivers must be able to understand and voluntarily provide written informed consent. Exclusion Criteria: - Children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 10 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Population Screening Cohort<br>A general population cohort of 9-month-old infants presenting for well-child visits will be screened initially at 9 months of age, and then screened again sequentially at 12, 15, 18, 21, and 24 months, to test screening performance relative to outcome status with autism or developmental disabilities. | Diagnostic Test: EarliPoint Investigational Device<br>* Infants will complete eye-tracking data collection at the age of 9 months on the EarliPoint Investigational Device. Eye-tracking video cameras will safely measure the movements of the child's eyes while they watch age-appropriate video scenes of other children playing together. Parents/Caregivers will complete screening forms and questionnaires about their baby's health and development. Parents/caregivers will complete surveys about their child's development. The surveys will be emailed, to be completed when the child is approximately 9, 12, 15, 18, 21, and 24 months old. If the child shows signs of developmental delay, the child will be asked to participate in a comprehensive developmental and diagnostic assessment.<br>* Other names: Screening test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months | Diagnostic performance as 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. | 18-26 months | 
| Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months. | Diagnostic performance as 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. | 18-26 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of social disability at 18-26 months compared to the Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) | Eye-tracking assays at 9 months will generate a social disability index; investigators will measure the correlation between that index and results on a standardized assessment by the ADOS-2 of autistic social disability conducted by expert clinicians at 18-26 months. | 18-26 months | 
| Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of verbal ability at 18-26 months compared to Mullen Scales of Early Learning (Mullen) | Eye-tracking assays at 9 months will generate verbal ability indices; investigators will measure the correlation between those indices and results from a standardized assessment of expressive and receptive language function (the Mullen Scales of Early Learning [Mullen]). | 18-26 months | 
| Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of nonverbal cognitive ability at 18-26 months. | Eye-tracking assays at 9 months will generate nonverbal ability indices; investigators will measure the correlation between those indices and results from a standardized assessment of nonverbal cognitive function (the Mullen Scales of Early Learning [Mullen], visual reception skills). | 18-26 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, well-baby visits, Social Development, Communicative Development, Development Disabilities, Autism Spectrum Disorders