Clinical trial NCT05916430: Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement
Official title: Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism
Infant Development
Keywords: Screening
well-baby visits
Social Development
Communicative Development
Development Disabilities
Autism Spectrum Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-06-23
Enrollment: 2120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants presenting for a 9-month well-child visit between the chronological ages of 8-10 months with no acute illnesses

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months
timeFrame: 18-26 months
measure: Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months.
timeFrame: 18-26 months
Secondary outcomes:
measure: 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)
timeFrame: 18-26 months
measure: 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)
timeFrame: 18-26 months
measure: Measure the ability of eye-tracking assays at 9 months to predict dimensional levels of nonverbal cognitive ability at 18-26 months.
timeFrame: 18-26 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Altanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Univeristy
state: Georgia
Study officials:
affiliation: Emory University
name: Warren R Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: