Clinical trial NCT06586788: Validation of Indiana's Early Evaluation Hub System
Official title: Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: primary care
biomarkers
eye-tracking
diagnosis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: National Institute of Mental Health (NIMH)
First posted: 2024-09-19
Enrollment: 154
Sex: ALL
Minimum age (years): 14
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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: 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.

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.

Primary outcomes:
measure: Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
timeFrame: Day 1
measure: Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Anderson
country: United States
facility: Community Health Network
state: Indiana
city: Batesville
country: United States
facility: Margaret Mary Health Pediatrics
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Muncie
country: United States
facility: Meridian Health Pediatrics
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Riley Children's Specialty Center
state: Indiana
city: South Bend
country: United States
facility: Primary Care Partners of South Bend
state: Indiana
city: Warsaw
country: United States
facility: Lutheran Health Physicians Pediatric Healthcare
state: Indiana
Study officials:
affiliation: IU School of Medicine
name: Rebecca McNally-Keehn, PhD, HSPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Brandon Keehn, PhD
role: PRINCIPAL_INVESTIGATOR
References: