Trial Outcomes & Findings for Validation of Indiana's Early Evaluation Hub System (NCT NCT06586788)
NCT ID: NCT06586788
Last Updated: 2024-10-31
Results Overview
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.
COMPLETED
NA
154 participants
Day 1
2024-10-31
Participant Flow
Seven EE Hubs set within primary care practices referred children, ages 14-48 months evaluated for autism in the community primary care setting, to the study between June 2019 and August 2022. To be included, children were age 14-48 months at time of EE Hub evaluation and had an English-speaking primary caregiver/guardian. Participating EE Hubs referred a prospective, consecutive sample of children who received an EE Hub evaluation.
Participant milestones
| Measure |
Children Undergoing Developmental Evaluation
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. 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 diagnostic outcome based on PCP diagnosis, diagnostic certainty, and biomarker measures.
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Children Undergoing Developmental Evaluation
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. 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 diagnostic outcome based on PCP diagnosis, diagnostic certainty, and biomarker measures.
|
|---|---|
|
Overall Study
Eye-tracking calibration / validation could not be completed with eight children
|
8
|
Baseline Characteristics
Validation of Indiana's Early Evaluation Hub System
Baseline characteristics by cohort
| Measure |
Children Undergoing Developmental Evaluation
n=146 Participants
Participating EE Hubs referred a prospective, consecutive sample of children who received an 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.
Eyelink Portable Duo: Eye movements and pupil diameter will be collected while participants view a series of developmentally appropriate pictures and movies. Children will be asked to sit in highchair or on a caregiver's lap and will face a computer monitor. 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.
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|---|---|
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Age, Continuous
|
2.55 years
STANDARD_DEVIATION 0.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / ethnicity · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / ethnicity · Black
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / ethnicity · Latine, any race
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / ethnicity · Non-Latine White
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / ethnicity · More than one race
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / ethnicity · Unspecified or not reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
146 participants
n=5 Participants
|
|
Composite Eye-tracking Biomarker
|
89 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The number of participants analyzed does not differ from the number of participants assigned to this arm.
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.
Outcome measures
| Measure |
Autism (Reference Standard)
n=102 Participants
Reference standard autism diagnosis 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
|
Non-Autism (Reference Standard)
n=44 Participants
Reference standard non-autism diagnosis 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
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|---|---|---|
|
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
Autism (index test)
|
79 Participants
|
10 Participants
|
|
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
Non-autism (index test)
|
23 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Because the goal of tiered diagnostic models, such as the EAE Hub system, is that PCPs can rule in/out autism in a subset of children and refer more complicated cases to a specialist, terminal nodes for the CART analysis were identified as autism, non-autism, or refer. As such, the number of participants analyzed differs from the number of participants assigned to the arm. A total of 19 children were classified as refer, and thus the total number of participants was 127.
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.
Outcome measures
| Measure |
Autism (Reference Standard)
n=97 Participants
Reference standard autism diagnosis 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
|
Non-Autism (Reference Standard)
n=30 Participants
Reference standard non-autism diagnosis 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
|
|---|---|---|
|
Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
Autism (index text)
|
88 Participants
|
4 Participants
|
|
Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
Non-Autism (index text)
|
9 Participants
|
26 Participants
|
Adverse Events
Children Undergoing Developmental Evaluation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place