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Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children | Clinical Trials | Clareo Health

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Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children

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

NCT05675371•EarliTec Diagnostics, Inc

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

1 - 7 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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.
+9 more criteria

Exclusion Criteria

•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.
•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.
+6 more criteria

Locations (9)

Southwest Autism Research and Resource Center (SARRC)

Phoenix, Arizona, United States

Cortica - Glendale

Glendale, California, United States

Cortica - Marin

San Rafael, California, United States

Cortica - Torrance

Torrance, California, United States

Cortica - Weslake Village

Westlake Village, California, United States

Emory University/Marcus Autism Center

Atlanta, Georgia, United States

Munroe-Meyer Institute / University of Nebraska

Omaha, Nebraska, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

AJ Drexel Autism Institute, Drexel University

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 31, 2023

Primary Completion Date

September 8, 2025

Completion Date

September 8, 2025

Last Updated

September 15, 2025

Enrollment

325

ACTUAL participants

Conditions

Autism Spectrum DisorderAutismDevelopmental DelayAutism, Early InfantileAutism, Infantile

Interventions

Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)

BEHAVIORAL

Assessment by the EarliPoint Assessment For Autism Spectrum Disorder

DEVICE

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258

Autism Spectrum DisorderGastrointestinal Diseases+1 more

View study

RECRUITING

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

NCT00271622

Neurologic DisordersAutism+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children

Inclusion Criteria

Exclusion Criteria

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs

Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

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Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients