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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH121747 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Purdue University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children Undergoing Developmental Evaluation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyelink Portable Duo | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca McNally-Keehn, PhD, HSPP | IU School of Medicine | Principal Investigator |
| Brandon Keehn, PhD | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Network | Anderson | Indiana | 46011 | United States | ||
| Margaret Mary Health Pediatrics |
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.
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Investigators will follow NIMH NDAR policies for submission of data.
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Included participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Children Undergoing Developmental Evaluation | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants analyzed does not differ from the number of participants assigned to this arm. | Posted | Count of Participants | Participants | Day 1 |
|
1 Day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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%).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca McNally Keehn | Indiana School of Medicine | (317) 274-2121 | mcnallyr@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2020 | Sep 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2021 | Sep 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Integrated PCP Diagnosis and Eye-tracking Biomarker | Diagnostic Test | 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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| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Composite Eye-tracking Biomarker | Participants with a composite eye-tracking biomarker indicative of autism | Count of Participants | Participants |
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| OG001 | Non-Autism (Reference Standard) | 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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| Primary | 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. | 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. | Posted | Count of Participants | Participants | Day 1 |
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| 0 |
| 154 |
| 0 |
| 154 |
| 0 |
| 154 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |