Validation of Indiana's Early Evaluation Hub System
EAER21
2 other identifiers
interventional
154
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2022
CompletedFirst Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedResults Posted
Study results publicly available
October 31, 2024
CompletedOctober 31, 2024
October 1, 2024
3.3 years
September 4, 2024
October 4, 2024
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 1
Study Arms (1)
Children Undergoing Developmental Evaluation
EXPERIMENTALParticipating 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Purdue Universitycollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (7)
Community Health Network
Anderson, Indiana, 46011, United States
Margaret Mary Health Pediatrics
Batesville, Indiana, 47006, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Meridian Health Pediatrics
Muncie, Indiana, 47304, United States
Deaconess Riley Children's Specialty Center
Newburgh, Indiana, 47630, United States
Primary Care Partners of South Bend
South Bend, Indiana, 46617, United States
Lutheran Health Physicians Pediatric Healthcare
Warsaw, Indiana, 46580, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
While the current study included a prospective, consecutively-referred sample of children evaluated for autism, a class imbalance was present; such an imbalance has the potential to overinflate accuracy metrics, and thus our findings should be interpreted with caution. Although 95% of children provided at least one usable eye-tracking measure, the percentage of usable data across each task varied significantly (50-94%).
Results Point of Contact
- Title
- Dr. Rebecca McNally Keehn
- Organization
- Indiana School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca McNally-Keehn, PhD, HSPP
IU School of Medicine
- PRINCIPAL INVESTIGATOR
Brandon Keehn, PhD
Purdue University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
June 7, 2019
Primary Completion
September 23, 2022
Study Completion
September 23, 2022
Last Updated
October 31, 2024
Results First Posted
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Investigators will follow NIMH NDAR policies for submission of data.
- Access Criteria
- Investigators will follow NIMH NDAR policies for submission of data. Other researchers nationwide can file an application with the NIMH to obtain access deidentified study data for research purposes.
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.