Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586788
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Validation of Indianas Early Evaluation Hub System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Indianas Early Neurodevelopmental Evaluation Hub Program
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAER21
Brief 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
Detailed Description:
Aim 1 Evaluate the diagnostic accuracy of the Early Evaluation EE Hub model of autism diagnosis in the community primary care setting The EE Hubs will refer a consecutive sample of children ages 16-48 months for comprehensive expert autism evaluation Diagnostic accuracy will be measured by comparing agreement between the EE Hub primary care providers PCP and expert autism-specialist on categorical diagnosis to estimate indices of diagnostic accuracy
Aim 2 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 eg 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
Aim 3 Determine whether a combination of clinical ie 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
Aim 2 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 eg 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
Aim 3 Determine whether a combination of clinical ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None