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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916430
• Other study ID #: IRB00115022
• Secondary ID: 5R01MH121363-03
• Status: Recruiting
• Start date: February 2, 2023
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Emory University
• Contact: FirstFocus Study
• Phone: 404-785-4529
• Email: FirstFocus[@]emory.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2120
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Months to 10 Months

Eligibility

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).

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Infant Development

Intervention

Diagnostic Test:
• EarliPoint Investigational Device
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Altanta	Atlanta	Georgia
United States	Emory Univeristy	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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