Validation of Indiana's Early Evaluation Hub System (EAER21)

Indiana University

Status: Completed

Conditions: Autism

Treatments: Diagnostic Test: Integrated PCP Diagnosis and Eye-tracking Biomarker; Diagnostic Test: Eyelink Portable Duo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06586788

1806262614

R21MH121747 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 14 to 48 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

Children Undergoing Developmental Evaluation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Eyelink Portable Duo

Diagnostic Test: Integrated PCP Diagnosis and Eye-tracking Biomarker