Study Results
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View full resultsBasic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2019-06-07
2022-09-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Children Undergoing Developmental Evaluation
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.
Eyelink Portable Duo
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.
Integrated PCP Diagnosis and Eye-tracking Biomarker
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.
Interventions
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Eyelink Portable Duo
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.
Integrated PCP Diagnosis and Eye-tracking Biomarker
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
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Inclusion Criteria
Children must have English-speaking caregivers. Children must have a legal guardian that is able to provide consent.
Exclusion Criteria
14 Months
48 Months
ALL
No
Sponsors
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Purdue University
OTHER
National Institute of Mental Health (NIMH)
NIH
Indiana University
OTHER
Responsible Party
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Rebecca McNally Keehn
Assistant Professor of Pediatrics
Principal Investigators
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Rebecca McNally-Keehn, PhD, HSPP
Role: PRINCIPAL_INVESTIGATOR
IU School of Medicine
Brandon Keehn, PhD
Role: PRINCIPAL_INVESTIGATOR
Purdue University
Locations
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Community Health Network
Anderson, Indiana, United States
Margaret Mary Health Pediatrics
Batesville, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Meridian Health Pediatrics
Muncie, Indiana, United States
Deaconess Riley Children's Specialty Center
Newburgh, Indiana, United States
Primary Care Partners of South Bend
South Bend, Indiana, United States
Lutheran Health Physicians Pediatric Healthcare
Warsaw, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1806262614
Identifier Type: -
Identifier Source: org_study_id
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