N/A
N=154
Validation of Indiana's Early Evaluation Hub System
Autism
Bottom Line
View on ClinicalTrials.gov: NCT06586788 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist — 79; 10; 23; 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eyelink Portable Duo (Diagnostic_test); Integrated PCP Diagnosis and Eye-tracking Biomarker (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist |
79; 10; 23; 34 | — |
| PRIMARY Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist |
88; 4; 9; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
Data sourced from ClinicalTrials.gov (NCT06586788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.