Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
MEASURE-ASD1
A Prospective, Multi-Center, Longitudinal Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) For Treatment Monitoring In Children With Autism Spectrum Disorder (ASD).
1 other identifier
observational
325
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedStudy Start
First participant enrolled
March 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2025
CompletedSeptember 15, 2025
September 1, 2025
2.4 years
December 21, 2022
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in EarliPoint Index Scores in typically developing children
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
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 Outcomes (3)
Relationship of the EarliPoint index scores to clinical reference assessments
180 days
Incidence of behavioral events which limit completion of an eye-tracking session.
180 days
Incidence of adverse device effects associated with use of the study device
180 days
Study Arms (4)
1a - Typically developing (ages 16-30 months)
Typically developing toddlers ages 16 - 30 months (chronological age).
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.
1b - Typically developing (ages 31-84 months)
Typically developing children ages 31-84 months (chronological age).
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.
Interventions
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
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
- Normal or corrected-to-normal vision with visual acuity and oculomotor function sufficient to watch short videos.
- Hearing adequate to hear information presented in age-appropriate videos of social interactions.
- 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.
- 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.
- 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).
- Subject's parent (or legally authorized representative) can understand information, instructions, and videos presented in the English language.
- Subject's parent (or legally authorized representative) can read and understand the Informed Consent Form (ICF).
- 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.
You may not qualify if:
- 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.
- Subject has an uncontrolled seizure disorder.
- 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).
- 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).
- Subject is receiving or plans to receive any investigational drug or device for the duration of this study.
- In the opinion of the Investigator, subject is not a suitable candidate for participation in a research study (NOTE: reason must be specified).
- Typically developing children who have a 1st degree relative with a diagnosis of autism and/or related developmental delay.
- 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.
- Normal or corrected-to-normal vision with visual acuity and oculomotor function sufficient to watch short videos.
- Hearing adequate to hear information presented in age-appropriate videos of social interactions.
- 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.
- 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.
- 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).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Southwest Autism Research and Resource Center (SARRC)
Phoenix, Arizona, 85006, United States
Cortica - Glendale
Glendale, California, 91203, United States
Cortica - Marin
San Rafael, California, 94903, United States
Cortica - Torrance
Torrance, California, 90503, United States
Cortica - Weslake Village
Westlake Village, California, 91361, United States
Emory University/Marcus Autism Center
Atlanta, Georgia, 30329, United States
Munroe-Meyer Institute / University of Nebraska
Omaha, Nebraska, 68106, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
AJ Drexel Autism Institute, Drexel University
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
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.
PMID: 37668621BACKGROUNDJones 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.
PMID: 37669054BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Reviere
Vice President, Clinical Affairs
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2022
First Posted
January 9, 2023
Study Start
March 31, 2023
Primary Completion
September 8, 2025
Study Completion
September 8, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share