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A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03469986
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
EarliTec Diagnostics, Inc

Study Description
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Brief Summary:

This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the gold-standard (reference standard), current best practice expert clinician diagnosis (ECD) of Autism Spectrum Disorder (ASD) in children 16-30 months of age.

Consecutive pediatric patients from the intended population (i.e. children 16-30 months of age) recruited from pediatric referrals and general advertisements will be the subjects of this trial. All subjects will undergo the MAC-ID diagnostic procedure (test). All subjects will also undergo the current best practice clinical diagnostic procedure, using standardized ASD diagnostic instruments and standardized developmental assessments, to produce the ECD of each child's ASD status (reference/gold standard).

The study consists of a screening phase and diagnostic evaluation phase to assess the validity (sensitivity and specificity), safety, and effectiveness of the MAC-ID when used to diagnose ASD.

Subjects will be enrolled in the trial for a period of 1 day. The trial will be completed in approximately 12 months.

The overall study objective is to assess the safety and effectiveness of the MAC-ID to accurately diagnose ASD (primary analysis), as well as to accurately assess severity of ASD (secondary analysis) in very young pediatric subjects.

The primary endpoints of this study are the diagnostic result from the MAC-ID and the diagnostic results from the ECD evaluation, both of which are either positive or negative for ASD. Each subject will undergo the Social Developmental Testing Device procedure and an examination by a clinical expert in the field of ASD diagnosis; all study center site personnel (including the expert clinicians responsible for the ECD evaluation) will be blinded to MAC-ID results.


Condition or disease Intervention/treatment
Autism Spectrum Disorder Device: Marcus Autism Center Investigational Device

Study Design
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Study Type : Observational
Actual Enrollment : 505 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prospective, Pivotal, Double-Blinded Within-subject Comparison of the Marcus Autism Center Investigational Device and Current Best Practice Clinical Diagnosis For Autism Spectrum Disorder in Pediatric Subjects 16-30 Months of Age
Actual Study Start Date : April 7, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Autism Spectrum Disorder
Children who meet criteria based on expert clinical diagnosis for autism spectrum disorder will be tested with the Marcus Autism Center Investigational Device and expert clinical assessment.
 Device: Marcus Autism Center Investigational Device
This trial will ascertain whether the binary results of autism or not-autism as determined by the Marcus Autism Center Investigational Device match expert clinical diagnostic opinion. The investigational device is designed to measure visual attention to social information in the environment relative to normative, age-specific benchmarks; these measurements assess presence (primary efficacy outcome) and severity (secondary outcomes) of autism spectrum disorder in 16- to 30-month-old children.
Non-autism Spectrum Disorder
Children who do not meet criteria for autism spectrum disorder based on expert clinical diagnosis will be tested with the Marcus Autism Center Investigational Device and expert clinical assessment.
 Device: Marcus Autism Center Investigational Device
This trial will ascertain whether the binary results of autism or not-autism as determined by the Marcus Autism Center Investigational Device match expert clinical diagnostic opinion. The investigational device is designed to measure visual attention to social information in the environment relative to normative, age-specific benchmarks; these measurements assess presence (primary efficacy outcome) and severity (secondary outcomes) of autism spectrum disorder in 16- to 30-month-old children.


Outcome Measures
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Primary Outcome Measures :
  1. Presence of Autism Spectrum Disorder [ Time Frame: 1 day ]
    In a sample of 400, 200 ASD and 200 non-ASD, the investigational device binary determination of ASD versus non-ASD will match the clinician best estimate diagnosis with 70/70 sensitivity and specificity


Secondary Outcome Measures :
  1. Social disability index [ Time Frame: 1 day ]
    Using the Autism Diagnostic Observation Schedule, 2nd Edition, does the degree of deviation of visual engagement indicate the severity of autism symptomatology

  2. Verbal Ability Index [ Time Frame: 1 day ]
    Using the verbal domains of the Mullen Scales of Early Learning, does the degree of does the degree of deviation of visual engagement indicate the level of verbal abilities

  3. Nonverbal Ability Index [ Time Frame: 1 day ]
    Using the nonverbal domain of the Mullen Scales of Early Learning, does the degree of does the degree of deviation of visual engagement indicate the level of nonverbal abilities


Eligibility Criteria
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Ages Eligible for Study:   16 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited on the basis of concern for ASD, including children who a parent, caregiver, or clinician suspects may have ASD as well as children who are not suspected to have an ASD.
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in this study:

  1. Boys and girls between 16 and 30 months of age
  2. Generally healthy with no acute illnesses by physical examination
  3. Normal or corrected-to-normal vision, in terms of visual acuity and oculomotor function, sufficient to watch short videos. Adequate hearing to hear material presented in videos
  4. Subject and parent can communicate meaningfully in English with the principal investigator and the clinical study site staff
  5. Subject's parent or guardian is able to read and understand the informed consent form
  6. Parent voluntarily provides written informed consent

Exclusion Criteria:

Any subject who meets any of the exclusion criteria will be excluded from participation in this study:

  1. Known genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, Muscular Dystrophy, Neurofibromatosis, Down Syndrome)
  2. Severe hearing or visual impairment as determined on physical examination (e.g., congenital nystagmus, congenital cataracts, previous diagnosis of severe hearing deficits by otoacoustic emissions or auditory brainstem response)
  3. Acute illnesses likely to prevent successful or valid data collection, i.e., conjunctivitis, fever, uncontrolled allergy symptoms, etc.
  4. Uncontrolled epilepsy or seizure disorder
  5. History or presence of a clinically significant medical disease, or a mental state that might confound the study or be detrimental to the subject as determined by the investigator
  6. Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
  7. Receiving therapies that may affect vision, i.e., currently receiving or have received the following therapies within 2 weeks of screening: topiramate, chlorpromazine, thioridazine, prednisone, prednisolone (including ophthalmic solutions and ointments), diphenhydramine, or hydroxyzine; or have received ophthalmic antibiotics within 3 days of screening: tobramycin, ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin and ofloxacin solutions and/or bacitracin ointment
  8. Receiving therapies that may affect the ability to focus attention on the videos, i.e., if on central nervous system (CNS) stimulants, CNS depressants, or anticonvulsants, dose must be stable (same dose for at least 2 weeks).
  9. Known allergies or sensitivity to the plastic, leather, or metal components used in the materials of the Social Developmental Testing Device seat
  10. Unable or unwilling to sit in a car seat, e.g., child has tantrums on nearly all occasions when placed in a car seat and tantrums do not subside within 5 minutes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469986


Locations
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United States, Arizona
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
EarliTec Diagnostics, Inc
Investigators
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Principal Investigator: Cheryl Klaiman, PhD Children's Healthcare of Atlanta and Emory University
More Information
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Additional Information:

Publications of Results:

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Responsible Party: EarliTec Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT03469986    
Other Study ID Numbers: S-DTD-2014-301
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders