AutismNCT05916430
Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement
An observational study of Autism and Infant Development, run by Emory University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism, Infant Development
- What is being tested?
- EarliPoint Investigational Device
- How many people
- 2,120 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants presenting for a 9-month well-child visit between the chronological ages of 8-10 months with no acute illnesses
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
FirstFocus Study, 404-785-4529, FirstFocus@emory.edu
Cheryl Klaiman, PhD, 404-785-9387, cklaima@emory.edu
- Recruiting
Emory University
Atlanta, Georgia, 30329
FirstFocus Study, 404-785-4529, FirstFocus@emory.edu
Cheryl Klaiman, PhD, 404-785-9387, cklaima@emory.edu
About this study
Official title: Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement
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.
Read the 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.
- Conditions
- Autism, Infant Development
- Being tested
- EarliPoint Investigational Device
- Keywords
- Screening, well-baby visits, Social Development, Communicative Development, Development Disabilities, Autism Spectrum Disorders
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarliPoint Investigational DeviceDiagnostic test
Also called Screening test
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.
| Study group | Role | What they receive |
|---|---|---|
| General Population Screening Cohort | 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. Receives: Diagnostic Test: EarliPoint Investigational Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 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 ASD or non-ASD.
Measured: 24 months
Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 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.
Measured: 24 months
Secondary outcomes (3)
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.
Measured: 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 the Mullen Scales of Early Learning
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). Receptive Language and Expressive Language Scales of the Mullen Scales of Early Learning (standardized measures of language function). Each item within these scales is scored either from 0 to 5 points for certain items or as 0 (skill not demonstrated) or 1 (correct response) for others. Raw scores are calculated by summing item-level ratings from the basal to the ceiling item. These raw scores are converted to standardized T-scores for analysis and interpretation (range: approximately 20-80 T-score; mean = 50, SD = 10; higher scores = better performance). The MSEL also yields an Early Learning Composite (mean = 100, SD = 15; higher scores = better overall performance).
Measured: 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 assess the correlation between those indices and results from the Visual Reception Scale of the Mullen Scales of Early Learning (a standardized measure of nonverbal cognitive function). Each item on the Visual Reception Scale is scored either from 0 to 5 points for certain items or as 0 (skill not demonstrated) or 1 (correct response) for others. Raw scores are calculated by summing item-level ratings from the basal to the ceiling item. These raw scores are converted to standardized T-scores for analysis and interpretation (range: approximately 20-80 T-score; mean = 50, SD = 10; higher scores = better performance).
Measured: 18-26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start2 Feb 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Warren R. Jones, Emory University
- Investigators
- Warren R Jones, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916430
- Sponsor's protocol ID
- IRB00115022
- Other IDs
- 5R01MH121363-03, 2025P013120
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data are planned to be publicly reposited in the NIMH Data Archive (https://nda.nih.gov) after publication, with accession number added when available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement
- ClinicalTrials.gov ID
- NCT05916430
- Acronym / sponsor ID
- IRB00115022
- Conditions
- Autism, Infant Development
- Keywords
- Screening, well-baby visits, Social Development, Communicative Development, Development Disabilities, Autism Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,120 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Population Screening Cohort | – | Diagnostic Test: EarliPoint Investigational DeviceA 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. |
Who may qualify
- Ages
- 8 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants presenting for a 9-month well-child visit between the chronological ages of 8-10 months with no acute illnesses
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarliPoint Investigational DeviceAlso: Screening testInfants 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. | Diagnostic test | General Population Screening Cohort |
Primary outcome
Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months
Time frame: 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 ASD or non-ASD.
Accuracy of eye-tracking assays at 9 months relative to Affected (ASD or DD) vs. Unaffected status at 24 months.
Time frame: 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.
3 secondary outcomes
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)
Time frame: 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 the Mullen Scales of Early Learning
Time frame: 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.
Time frame: 18-26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Data are planned to be publicly reposited in the NIMH Data Archive (https://nda.nih.gov) after publication, with accession number added when available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Warren R Jones, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Infant Development, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FirstFocus Study (404-785-4529, FirstFocus@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of eye-tracking assays at 9 months relative to ASD vs. non-ASD diagnosis at 24 months (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.