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Autism Spectrum DisorderNCT03469986

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

An observational study of Autism Spectrum Disorder, run by EarliTec Diagnostics, Inc at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 30 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Marcus Autism Center Investigational Device
Type of treatment
Medical device
How many people
505 participants
Where
6 sitesUnited States
Study dates
7 Apr 2018to 31 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 months
  • All sexes
  • Child

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.

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to participate in this study:
  • Boys and girls between 16 and 30 months of age
  • Generally healthy with no acute illnesses by physical examination
  • 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
  • Subject and parent can communicate meaningfully in English with the principal investigator and the clinical study site staff
  • Subject's parent or guardian is able to read and understand the informed consent form
  • Parent voluntarily provides written informed consent

Who cannot join

  • Any subject who meets any of the exclusion criteria will be excluded from participation in this study:
  • Known genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, Muscular Dystrophy, Neurofibromatosis, Down Syndrome)
  • 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)
  • Acute illnesses likely to prevent successful or valid data collection, i.e., conjunctivitis, fever, uncontrolled allergy symptoms, etc.
  • Uncontrolled epilepsy or seizure disorder
  • 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
Show all 11Show fewer
  • Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
  • 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
  • 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).
  • Known allergies or sensitivity to the plastic, leather, or metal components used in the materials of the Social Developmental Testing Device seat
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Emory University

    Atlanta, Georgia, 30329

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006

  • University of California San Francisco

    San Francisco, California, 94143

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

About this study

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

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).

Read more

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.

Being tested
Marcus Autism Center Investigational Device
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Marcus Autism Center Investigational DeviceDevice

    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.

Study groups in NCT03469986
Study groupRoleWhat they receive
Autism Spectrum DisorderChildren 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.
Receives: Device: Marcus Autism Center Investigational Device
Non-autism Spectrum DisorderChildren 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.
Receives: Device: Marcus Autism Center Investigational Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of Autism Spectrum Disorder

    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

    Measured: 1 day

Secondary outcomes (3)

  1. Social disability index

    Using the Autism Diagnostic Observation Schedule, 2nd Edition, does the degree of deviation of visual engagement indicate the severity of autism symptomatology

    Measured: 1 day

  2. Verbal Ability Index

    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

    Measured: 1 day

  3. Nonverbal Ability Index

    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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start7 Apr 2018
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03469986
Sponsor's protocol ID
S-DTD-2014-301
Status last verified
Nov 2023
First submitted
12 Mar 2018
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Jones W, Klaiman C, Richardson S, Lambha M, Reid M, Hamner T, Beacham C, Lewis P, Paredes J, Edwards L, Marrus N, Constantino JN, Shultz S, Klin A. Development and Replication of Objective Measurements of Social Visual Engagement to Aid in Early Diagnosis and Assessment of Autism. JAMA Netw Open. 2023 Sep 5;6(9):e2330145. doi: 10.1001/jamanetworkopen.2023.30145.

    PubMed 37669054

  • Jones W, Klaiman C, Richardson S, Aoki C, Smith C, Minjarez M, Bernier R, Pedapati E, Bishop S, Ence W, Wainer A, Moriuchi J, Tay SW, Klin A. Eye-Tracking-Based Measurement of Social Visual Engagement Compared With Expert Clinical Diagnosis of Autism. JAMA. 2023 Sep 5;330(9):854-865. doi: 10.1001/jama.2023.13295.

    PubMed 37668621

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by EarliTec Diagnostics, Inc at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Autism Spectrum Disorder (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03469986, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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