AutismEAER21NCT06586788
Validation of Indiana's Early Evaluation Hub System
A study testing Eyelink Portable Duo and Integrated PCP Diagnosis and Eye-tracking Biomarker in people with Autism, run by Indiana University at 7 sites in United States.
Trial summary
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting. Read more about this study
- Who is it for?
- Ages 14 to 48 months
- Conditions the study is for
- Autism
- What is being tested?
- Eyelink Portable Duo and Integrated PCP Diagnosis and Eye-tracking Biomarker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Jun 2019to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Young children ages 14-48 months seen at an EE hub and referred for a comprehensive autism evaluation.
- Children must have English-speaking caregivers. Children must have a legal guardian that is able to provide consent.
Who cannot join
- Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Community Health Network
Anderson, Indiana, 46011
Margaret Mary Health Pediatrics
Batesville, Indiana, 47006
Riley Hospital for Children
Indianapolis, Indiana, 46202
Meridian Health Pediatrics
Muncie, Indiana, 47304
Deaconess Riley Children's Specialty Center
Newburgh, Indiana, 47630
Primary Care Partners of South Bend
South Bend, Indiana, 46617
Lutheran Health Physicians Pediatric Healthcare
Warsaw, Indiana, 46580
About this study
Official title: Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.
Read the detailed description
Determine whether eye-tracking biomarkers can reliably differentiate young children with and without autism in a community referred sample. The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. Differences in metrics between children with and without autism will be compared to validate potential eye-tracking biomarkers.
Determine whether a combination of clinical (i.e., EE Hub PCP measures) and eye-tracking biomarkers can be used to accurately predict autism diagnostic outcome in a sample of young children evaluated for autism in the primary care setting.
- Conditions
- Autism
- Being tested
- Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker
- Keywords
- primary care, biomarkers, eye-tracking, diagnosis
- Medical subject headings
- Autistic Disorder, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyelink Portable DuoDiagnostic test
Eye-tracking data will be collected using a commercially-available remote eye-tracking system (Eyelink Portable Duo). Eye movements and pupil diameter will be collected while participants view a series of developmentally appropriate pictures and movies. The eye-tracker consists of two cameras; one that monitors eye movements and a second scene camera that monitors head movements, which permits eye tracking to take place without any equipment touching the child. Children will be asked to sit in highchair or on a caregiver's lap and will face a computer monitor. After a sticker is applied to the child's forehead and brief eye-movement calibration completed, next visual stimuli (i.e., pictures and videos) will be presented on a laptop computer monitor that is placed at approximately 60-80cm from the child. The eye tracking portion of the visit will last approximately 15 minutes or until the child is no longer able to attend to pictures/videos.
Integrated PCP Diagnosis and Eye-tracking BiomarkerDiagnostic test
A Classification and Regression Tree (CART) Analysis, based on recursive partitioning, was used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency [sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child]) best predicted reference standard autism diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Children Undergoing Developmental Evaluation | Experimental | Participating EE Hubs referred a prospective, consecutive sample of children who received an EE Hub evaluation. Next, the study team traveled to the EE Hub to conduct a follow-up gold-standard autism diagnostic assessment (reference standard diagnosis) and eye-tracking biomarker battery (index test; Aim 2) within 16 weeks of EE Hub evaluation. Reference standard diagnosis was made by a licensed clinical psychologist with expertise in autism diagnosis based upon a research evaluation including the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Vineland Adaptive Behaviors Scale, Third Edition (VABS-3), Mullen Scales of Early Learning (MSEL), and a caregiver interview to assess for DSM-5 autism criteria. Children also completed a short (< 15min) eye-tracking activity where the children view a series of different images/videos while the children's eye movements and pupil diameter was measured. Receives: Diagnostic Test: Eyelink Portable Duo; Diagnostic Test: Integrated PCP Diagnosis and Eye-tracking Biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
Sensitivity and specificity of a composite eye-tracking (i.e., index) test, which was a consolidated measure based on significant eye-tracking indices, compared to reference standard expert clinical autism diagnosis.
Measured: Day 1
Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
Classification and Regression Tree (CART) analysis, based on recursive partitioning, is used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency [sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child]) best predicted reference standard autism diagnosis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Jun 2019
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca McNally Keehn, Indiana University
- Investigators
- Rebecca McNally-Keehn, PhD, HSPP, Principal investigator, IU School of MedicineBrandon Keehn, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586788
- Sponsor's protocol ID
- 1806262614
- Other IDs
- R21MH121747
- Acronym
- EAER21
- Status last verified
- Oct 2024
- First submitted
- 4 Sep 2024
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data from this study is submitted to the National Institute of Mental Health Data Archive (NDA). NDA is a data repository run by the National Institute of Mental Health (NIMH) that allows researchers studying autism and other conditions to collect and share deidentified information with each other. A data repository is a large database where information from many studies is stored and managed. During and after the study, the researchers will send deidentified information to NDA. Other researchers nationwide can then file an application with the NIMH to obtain access deidentified study data for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program
- ClinicalTrials.gov ID
- NCT06586788
- Acronym / sponsor ID
- EAER21 / 1806262614
- Conditions
- Autism
- Keywords
- primary care, biomarkers, eye-tracking, diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institute of Mental Health (NIMH)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.
Detailed description
Determine whether eye-tracking biomarkers can reliably differentiate young children with and without autism in a community referred sample. The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. Differences in metrics between children with and without autism will be compared to validate potential eye-tracking biomarkers.
Determine whether a combination of clinical (i.e., EE Hub PCP measures) and eye-tracking biomarkers can be used to accurately predict autism diagnostic outcome in a sample of young children evaluated for autism in the primary care setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Undergoing Developmental Evaluation | Experimental | Diagnostic Test: Eyelink Portable Duo, Diagnostic Test: Integrated PCP Diagnosis and Eye-tracking BiomarkerParticipating EE Hubs referred a prospective, consecutive sample of children who received an EE Hub evaluation. Next, the study team traveled to the EE Hub to conduct a follow-up gold-standard autism diagnostic assessment (reference standard diagnosis) and eye-tracking biomarker battery (index test; Aim 2) within 16 weeks of EE Hub evaluation. Reference standard diagnosis was made by a licensed clinical psychologist with expertise in autism diagnosis based upon a research evaluation including the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Vineland Adaptive Behaviors Scale, Third Edition (VABS-3), Mullen Scales of Early Learning (MSEL), and a caregiver interview to assess for DSM-5 autism criteria. Children also completed a short (< 15min) eye-tracking activity where the children view a series of different images/videos while the children's eye movements and pupil diameter was measured. |
Who may qualify
- Ages
- 14 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Young children ages 14-48 months seen at an EE hub and referred for a comprehensive autism evaluation.
- Children must have English-speaking caregivers. Children must have a legal guardian that is able to provide consent.
Key exclusion criteria (1 listed)
- Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
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 |
|---|---|---|
| Eyelink Portable DuoEye-tracking data will be collected using a commercially-available remote eye-tracking system (Eyelink Portable Duo). Eye movements and pupil diameter will be collected while participants view a series of developmentally appropriate pictures and movies. The eye-tracker consists of two cameras; one that monitors eye movements and a second scene camera that monitors head movements, which permits eye tracking to take place without any equipment touching the child. Children will be asked to sit in highchair or on a caregiver's lap and will face a computer monitor. After a sticker is applied to the child's forehead and brief eye-movement calibration completed, next visual stimuli (i.e., pictures and videos) will be presented on a laptop computer monitor that is placed at approximately 60-80cm from the child. The eye tracking portion of the visit will last approximately 15 minutes or until the child is no longer able to attend to pictures/videos. | Diagnostic test | Children Undergoing Developmental Evaluation |
| Integrated PCP Diagnosis and Eye-tracking BiomarkerA Classification and Regression Tree (CART) Analysis, based on recursive partitioning, was used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency [sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child]) best predicted reference standard autism diagnosis. | Diagnostic test | Children Undergoing Developmental Evaluation |
Primary outcome
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
Time frame: Day 1
Sensitivity and specificity of a composite eye-tracking (i.e., index) test, which was a consolidated measure based on significant eye-tracking indices, compared to reference standard expert clinical autism diagnosis.
Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
Time frame: Day 1
Classification and Regression Tree (CART) analysis, based on recursive partitioning, is used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency [sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child]) best predicted reference standard autism diagnosis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data from this study is submitted to the National Institute of Mental Health Data Archive (NDA). NDA is a data repository run by the National Institute of Mental Health (NIMH) that allows researchers studying autism and other conditions to collect and share deidentified information with each other. A data repository is a large database where information from many studies is stored and managed. During and after the study, the researchers will send deidentified information to NDA. Other researchers nationwide can then file an application with the NIMH to obtain access deidentified study data for research purposes.
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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. This study is not recruiting at the moment.
Rebecca McNally-Keehn, PhD, HSPP principal investigator
IU School of Medicine
Brandon Keehn, PhD principal investigator
Purdue University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyelink Portable Duo and Integrated PCP Diagnosis and Eye-tracking Biomarker in people with Autism, run by Indiana University at 7 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 2 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist (time frame: Day 1). 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 31 Oct 2024.