Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children (MEASURE-ASD1)

February 2, 2024 updated by: EarliTec Diagnostics, Inc

A Prospective, Multi-Center, Longitudinal Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) For Treatment Monitoring In Children With Autism Spectrum Disorder (ASD).

The goal of this clinical study is to learn about the utility and performance of the EarliPoint(™) System: Evaluation for Autism Spectrum Disorder to monitor changes in a child's verbal ability, non-verbal learning, and social disability over time in children ages 15-84 months with autism spectrum disorder or related developmental delays (DD) and in those who are typically developing.

The main questions it aims to answer are:

  • To estimate the change in each of the EarliPoint index scores in typically developing children ages 15-84 months from baseline through 180 days as a function of the child's age.
  • To estimate the change in the EarliPoint verbal and non-verbal index scores in ASD/DD children ages 15-84 months from baseline through 180 days as a function of the child's age in: a) those who showed clinical improvement, and b) those who did not show clinical improvement.
  • To estimate the relationship of the EarliPoint verbal and non-verbal index scores to clinical reference assessments in ASD/DD children as a function of their age from baseline through 180 days.
  • To estimate the degree of change, if change occurs, month-to-month in the EarliPoint Social Disability Index score from baseline through 180 days.
  • To estimate the incidence of behavioral events (e.g., tantrums, etc.) which limit the subject from completing an eye-tracking session.
  • To estimate the incidence of adverse device effects associated with the use of the study device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study seeks to evaluate the utility and performance of the EarliPoint(™) System: Evaluation for Autism Spectrum Disorder in monitoring changes in a child's verbal ability, non-verbal learning, and social disability over time in children ages 15-84 months with autism spectrum disorder and in those who are typically developing.

The main questions it aims to answer are:

  • To estimate the change in each of the EarliPoint index scores in typically developing children ages 15-84 months from baseline through 180 days as a function of the child's age.
  • To estimate the change in the EarliPoint verbal and non-verbal index scores in ASD/DD children ages 15-84 months from baseline through 180 days as a function of the child's age in: a) those who showed clinical improvement, and b) those who did not show clinical improvement.
  • To estimate the relationship of the EarliPoint verbal and non-verbal index scores to clinical reference assessments in ASD/DD children as a function of their age from baseline through 180 days.
  • To estimate the degree of change, if change occurs, month-to-month in the EarliPoint Social Disability Index score from baseline through 180 days.
  • To estimate the incidence of behavioral events (e.g., tantrums, etc.) which limit the subject from completing an eye-tracking session.
  • To estimate the incidence of adverse device effects associated with the use of the study device.

Study Type

Observational

Enrollment (Estimated)

332

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Southwest Autism Research and Resource Center (SARRC)
        • Principal Investigator:
          • Christopher Smith, PhD
        • Contact:
    • California
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory University/Marcus Autism Center
        • Principal Investigator:
          • Stormi Pulver-White, PsyD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • Recruiting
        • Munroe-Meyer Institute / University of Nebraska
        • Principal Investigator:
          • Alice Shillingsburg, PhD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Rebecca Shaffer, PysD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • AJ Drexel Autism Institute, Drexel University
        • Contact:
        • Principal Investigator:
          • Giacomo Vivanti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children ages 15-84 months (at time of enrollment) who have a diagnosis of autism spectrum disorder/related developmental delay and are actively undergoing applied behavioral analysis or related therapy or those who are typically-developing.

Description

Inclusion Criteria (cohort 1a):

Subjects must meet all the following inclusion criteria to participate in Cohort 1a.

  1. Male or female individuals between the ages of 15-30 months (chronological age) at the time of consent who have autism spectrum disorder and/or related developmental delays or those who are typically developing.
  2. Normal or corrected-to-normal vision with visual acuity and oculomotor function sufficient to watch short videos.
  3. Hearing adequate to hear information presented in age-appropriate videos of social interactions.
  4. For individuals who have autism spectrum disorder and/or related developmental delays, the subject must be established in treatment (e.g., a treatment plan has been developed and child is undergoing treatment or will immediately begin treatment) and intends to remain in treatment continuously throughout the duration of the study. Additionally, individuals must provide a diagnostic report documenting a positive diagnosis of ASD/DD available for review. If a report is not available, subjects must undergo diagnostic evaluation prior to enrolling into the study.
  5. For individuals who are typically developing, the parent, referring clinician and/or daycare center have indicated that the child is not suspected of, nor has he/she exhibited signs of, developmental delays. NOTE: If, at screening, the investigator suspects the typically developing (TD) subject of having a developmental delay (based on feedback from referring clinician and/or daycare center along with expert clinician opinion), the subject shall be screen failed. He/she should be referred for diagnosis and then may be re-screened for the study.
  6. Subject and parent (or legally authorized representative) are able and agree to attend each required study visit and complete the full battery of psychometric assessments and questionnaires (electronically or in-person where required).
  7. Subject's parent (or legally authorized representative) can understand information, instructions, and videos presented in the English language.
  8. Subject's parent (or legally authorized representative) can read and understand the Informed Consent Form (ICF).
  9. Subject's parent (or legally authorized representative) provides written informed consent allowing the child subject to participate in the study. NOTE: where able, the child subject should also provide assent.

Exclusion criteria (cohort 1a):

Subjects who meet any of the following exclusion criteria are not eligible to participate in Cohort 1a:

  1. Severe hearing or visual impairment (e.g., congenital nystagmus, congenital cataracts, previous diagnosis of severe hearing deficits by otoacoustic emissions or auditory brainstem response), which in the opinion of the investigator, would limit the child from completing the EarliPoint eye-tracking procedure or clinical reference assessments.

    Note: Corrective lenses are allowable up to a prescription of +/- 5.0.

  2. Subject has an uncontrolled seizure disorder.
  3. Subject is unable or unwilling to undergo DQSVE testing for up to 15 minutes per assessment (e.g., child has frequent tantrums and tantrums do not subside within 5 minutes).
  4. In the opinion of the investigator, the subject and/or parent (or legally authorized representative) are unable, unwilling, or unlikely to comply with all study required procedures and follow-up assessments or to complete the full battery of psychometric assessments (electronically or in-person where required).
  5. Subject is receiving or plans to receive any investigational drug or device for the duration of this study.
  6. In the opinion of the Investigator, subject is not a suitable candidate for participation in a research study (NOTE: reason must be specified).
  7. Typically developing children who have a 1st degree relative with a diagnosis of autism and/or related developmental delay.

Inclusion criteria (module 1b):

Subjects must meet all the following inclusion criteria to participate in this Cohort 1b.

  1. Male or female individuals between the ages of 31-78 months (chronological age) at the time of consent who have autism spectrum disorder and/or related developmental delays or those who are typically developing.

    Note: The EarliPoint system is currently configured to monitor children between the ages of 31-84 months. Therefore, at the time of enrollment, participants must be 78 months to facilitate monitoring through 6 months of follow-up.

  2. Normal or corrected-to-normal vision with visual acuity and oculomotor function sufficient to watch short videos.
  3. Hearing adequate to hear information presented in age-appropriate videos of social interactions.
  4. For individuals who have autism spectrum disorder and/or related developmental delays, the subject must be established in treatment (e.g., a treatment plan has been developed and child is undergoing treatment or will immediately begin treatment) and intends to remain in treatment continuously throughout the duration of the study. Additionally, individuals must provide a diagnostic report documenting a positive diagnosis of ASD/DD available for review. If a report is not available, subjects must undergo diagnostic evaluation prior to enrolling into the study.
  5. For individuals who are typically developing, the parent, referring clinician and/or daycare center have indicated that the child is not suspected of, nor has he/she exhibited signs of, developmental delays. NOTE: If, at screening, the investigator suspects the TD subject of having a developmental delay (based on feedback from referring clinician and/or daycare center along with expert clinician opinion), the subject shall be screen failed. He/she should be referred for diagnosis and then may be re-screened for the study.
  6. Subject and parent (or legally authorized representative) are able and agree to attend each required study visit and complete the full battery of psychometric assessments and questionnaires (electronically or in-person where required).
  7. Subject's parent (or legally authorized representative) can understand information, instructions, and videos presented in the English language.
  8. Subject's parent (or legally authorized representative) can read and understand the Informed Consent Form (ICF).
  9. Subject's parent (or legally authorized representative) provides written informed consent allowing the child subject to participate in the study. NOTE: where able, the child subject should also provide assent.

Exclusion criteria (module 1b):

Subjects who meet any of the following exclusion criteria are not eligible to participate in Cohort 1b:

  1. Severe hearing or visual impairment (e.g., congenital nystagmus, congenital cataracts, previous diagnosis of severe hearing deficits by otoacoustic emissions or auditory brainstem response), which in the opinion of the investigator, would limit the child from completing the EarliPoint eye-tracking procedure or clinical reference assessments.

    Note: Corrective lenses are allowable up to a prescription of +/- 5.0.

  2. Subject has an uncontrolled seizure disorder.
  3. Subject is unable or unwilling to undergo DQSVE testing for up to 15 minutes per assessment (e.g., child has frequent tantrums and tantrums do not subside within 5 minutes).
  4. In the opinion of the investigator, the subject and/or parent (or legally authorized representative) are unable, unwilling, or unlikely to comply with all study required procedures and follow-up assessments or to complete the full battery of psychometric assessments (electronically or in-person where required).
  5. Subject is receiving or plans to receive any investigational drug or device for the duration of this study.
  6. In the opinion of the Investigator, subject is not a suitable candidate for participation in a research study (NOTE: reason must be specified).
  7. Typically developing children who have a 1st degree relative with a diagnosis of autism and/or related developmental delay.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1a - Typically developing (ages 16-30 months)
Typically developing toddlers ages 16 - 30 months (chronological age).
Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)
Assessment (e.g., responder vs. non-responder status) utilizing gold-standard clinical reference assessments performed by expert clinicians as the subject undergoes Applied Behavioral Analysis (ABA) or similar intervention for autism spectrum disorder and related developmental delays
Other Names:
  • Applied Behavior Analysis
Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
Assessment by The EarliPoint™ Evaluation for Autism Spectrum Disorder (ASD), a medical device which employs Dynamic Quantification of Social-Visual Engagement (DQSVE) to aid clinicians in the diagnosis, assessment, and treatment monitoring of ASD related developmental delays, is a diagnostic tool which measures an individual's visual preferential attention to social information in the environment relative to normative age-specific benchmarks.
Other Names:
  • EarliPoint System: Assessment for Autism Spectrum Disorder
1a - ASD/DD (ages 16-30 months)
Toddlers ages 16-30 months with autism spectrum disorder and/or related developmental delay who are undergoing applied behavioral analysis (ABA) or related therapies.
Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)
Assessment (e.g., responder vs. non-responder status) utilizing gold-standard clinical reference assessments performed by expert clinicians as the subject undergoes Applied Behavioral Analysis (ABA) or similar intervention for autism spectrum disorder and related developmental delays
Other Names:
  • Applied Behavior Analysis
Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
Assessment by The EarliPoint™ Evaluation for Autism Spectrum Disorder (ASD), a medical device which employs Dynamic Quantification of Social-Visual Engagement (DQSVE) to aid clinicians in the diagnosis, assessment, and treatment monitoring of ASD related developmental delays, is a diagnostic tool which measures an individual's visual preferential attention to social information in the environment relative to normative age-specific benchmarks.
Other Names:
  • EarliPoint System: Assessment for Autism Spectrum Disorder
1b - Typically developing (ages 31-84 months)
Typically developing children ages 31-84 months (chronological age).
Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)
Assessment (e.g., responder vs. non-responder status) utilizing gold-standard clinical reference assessments performed by expert clinicians as the subject undergoes Applied Behavioral Analysis (ABA) or similar intervention for autism spectrum disorder and related developmental delays
Other Names:
  • Applied Behavior Analysis
Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
Assessment by The EarliPoint™ Evaluation for Autism Spectrum Disorder (ASD), a medical device which employs Dynamic Quantification of Social-Visual Engagement (DQSVE) to aid clinicians in the diagnosis, assessment, and treatment monitoring of ASD related developmental delays, is a diagnostic tool which measures an individual's visual preferential attention to social information in the environment relative to normative age-specific benchmarks.
Other Names:
  • EarliPoint System: Assessment for Autism Spectrum Disorder
1b - ASD/DD (ages 31-84 months)
Children ages 31-84 months with autism spectrum disorder and/or related developmental delay who are undergoing applied behavioral analysis (ABA) or related therapies.
Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)
Assessment (e.g., responder vs. non-responder status) utilizing gold-standard clinical reference assessments performed by expert clinicians as the subject undergoes Applied Behavioral Analysis (ABA) or similar intervention for autism spectrum disorder and related developmental delays
Other Names:
  • Applied Behavior Analysis
Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
Assessment by The EarliPoint™ Evaluation for Autism Spectrum Disorder (ASD), a medical device which employs Dynamic Quantification of Social-Visual Engagement (DQSVE) to aid clinicians in the diagnosis, assessment, and treatment monitoring of ASD related developmental delays, is a diagnostic tool which measures an individual's visual preferential attention to social information in the environment relative to normative age-specific benchmarks.
Other Names:
  • EarliPoint System: Assessment for Autism Spectrum Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EarliPoint Index Scores in typically developing children
Time Frame: 180 days
To estimate the change in each of the EarliPoint index scores in typically developing children ages 16-30 months form baseline through 180 days as a function of the child's age.
180 days
Change in EarliPoint Index Scores in ASD/DD children
Time Frame: 180 days
To estimate the change in the EarliPoint verbal and nonverbal index scores in ASD/DD children ages 16-30 months from baseline through 180 days as a function of the child's age in a) those who showed clinical improvement, and b) those who did not show clinical improvement.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of behavioral events which limit completion of an eye-tracking session.
Time Frame: 180 days
To estimate the incidence of behavioral events (e.g., tantrums, inability to calibrate device to child, etc.) which limit the subject from completing an eye-tracking session.
180 days
Incidence of adverse device effects associated with use of the study device
Time Frame: 180 days
To estimate the incidence of adverse device effects associated with the use of the study device.
180 days
Relationship of the EarliPoint index scores to clinical reference assessments
Time Frame: 180 days
To estimate the relationship of the EarliPoint verbal and nonverbal index scores to the Mullen Scales of Early Learning scores in ASD/DD children as a function of their age from baseline though 180-days.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EarliTec Diagnostics, Inc

Collaborators

Marcus Autism Center

Investigators

  • Study Director: John Reviere, Vice President, Clinical Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-1005 (Module 1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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