Autism Spectrum DisorderMEASURE-ASD1NCT05675371
Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
An observational study of Autism Spectrum Disorder and Autism, run by EarliTec Diagnostics, Inc at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Developmental Delay
- What is being tested?
- Assessment by Expert Clinician During Behavioral Intervention (ABA or similar) and Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 325 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Mar 2023to 8 Sep 2025
- 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 15 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Subjects must meet all the following inclusion criteria to participate in Cohort 1a.
- 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.
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- 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.
- Subjects must meet all the following inclusion criteria to participate in this Cohort 1b.
- 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).
- 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.
Who cannot join
- Subjects who meet any of the following exclusion criteria are not eligible to participate in Cohort 1a:
- 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).
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- 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.
- Subjects who meet any of the following exclusion criteria are not eligible to participate in Cohort 1b:
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University/Marcus Autism Center
Atlanta, Georgia, 30329
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cortica - Glendale
Glendale, California, 91203
Munroe-Meyer Institute / University of Nebraska
Omaha, Nebraska, 68106
AJ Drexel Autism Institute, Drexel University
Philadelphia, Pennsylvania, 19104
Southwest Autism Research and Resource Center (SARRC)
Phoenix, Arizona, 85006
Cortica - Marin
San Rafael, California, 94903
Cortica - Torrance
Torrance, California, 90503
Cortica - Weslake Village
Westlake Village, California, 91361
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Autism, Developmental Delay, Autism, Early Infantile, Autism, Infantile
- Being tested
- Assessment by Expert Clinician During Behavioral Intervention (ABA or similar), Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
- Keywords
- ASD, autism, autism spectrum disorder, developmental delay, autism in children, autism spectrum disorder in children, autism spectrum disorder in toddlers, autism in toddlers, EarliPoint System: Evaluation for Autism Spectrum Disorder, EarliPoint, DQSVE
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)Behavioural
Also called Applied Behavior Analysis
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 Assessment For Autism Spectrum DisorderDevice
Also called EarliPoint System: 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.
| Study group | Role | What they receive |
|---|---|---|
| 1a - Typically developing (ages 16-30 months) | Typically developing toddlers ages 16 - 30 months (chronological age). Receives: Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar); Device: Assessment by the EarliPoint 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. Receives: Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar); Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder | |
| 1b - Typically developing (ages 31-84 months) | Typically developing children ages 31-84 months (chronological age). Receives: Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar); Device: Assessment by the EarliPoint 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. Receives: Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar); Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 180 days
Secondary outcomes (3)
Relationship of the EarliPoint index scores to clinical reference assessments
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.
Measured: 180 days
Incidence of behavioral events which limit completion of an eye-tracking session.
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.
Measured: 180 days
Incidence of adverse device effects associated with use of the study device
To estimate the incidence of adverse device effects associated with the use of the study device.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start31 Mar 2023
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarliTec Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Reviere, Study director, Vice President, Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675371
- Sponsor's protocol ID
- CLN-1005 (Module 1)
- Acronym
- MEASURE-ASD1
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2022
- Last updated
- 15 Sep 2025
- 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, 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 37668621Jones 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Longitudinal Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) For Treatment Monitoring In Children With Autism Spectrum Disorder (ASD).
- ClinicalTrials.gov ID
- NCT05675371
- Acronym / sponsor ID
- MEASURE-ASD1 / CLN-1005 (Module 1)
- Conditions
- Autism Spectrum Disorder, Autism, Developmental Delay, Autism, Early Infantile, Autism, Infantile
- Keywords
- ASD, autism, autism spectrum disorder, developmental delay, autism in children, autism spectrum disorder in children, autism spectrum disorder in toddlers, autism in toddlers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- EarliTec Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1a - Typically developing (ages 16-30 months) | – | Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar), Device: Assessment by the EarliPoint Assessment For Autism Spectrum DisorderTypically developing toddlers ages 16 - 30 months (chronological age). |
| 1a - ASD/DD (ages 16-30 months) | – | Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar), Device: Assessment by the EarliPoint Assessment For Autism Spectrum DisorderToddlers 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) | – | Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar), Device: Assessment by the EarliPoint Assessment For Autism Spectrum DisorderTypically developing children ages 31-84 months (chronological age). |
| 1b - ASD/DD (ages 31-84 months) | – | Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar), Device: Assessment by the EarliPoint Assessment For Autism Spectrum DisorderChildren ages 31-84 months with autism spectrum disorder and/or related developmental delay who are undergoing applied behavioral analysis (ABA) or related therapies. |
Who may qualify
- Ages
- 15 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (21 listed)
- Subjects must meet all the following inclusion criteria to participate in Cohort 1a.
- 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.
Key exclusion criteria (18 listed)
- Subjects who meet any of the following exclusion criteria are not eligible to participate in Cohort 1a:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)Also: Applied Behavior AnalysisAssessment (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 | Behavioural | 1a - ASD/DD (ages 16-30 months), 1a - Typically developing (ages 16-30 months), 1b - ASD/DD (ages 31-84 months), 1b - Typically developing (ages 31-84 months) |
| Assessment by the EarliPoint Assessment For Autism Spectrum DisorderAlso: EarliPoint System: Assessment for Autism Spectrum DisorderAssessment 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. | Device | 1a - ASD/DD (ages 16-30 months), 1a - Typically developing (ages 16-30 months), 1b - ASD/DD (ages 31-84 months), 1b - Typically developing (ages 31-84 months) |
Primary outcome
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.
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.
3 secondary outcomes
Relationship of the EarliPoint index scores to clinical reference assessments
Time frame: 180 days
Incidence of behavioral events which limit completion of an eye-tracking session.
Time frame: 180 days
Incidence of adverse device effects associated with use of the study device
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 37668621Jones 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.
- Background: PubMed 37669054Jones 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.
- EarliPoint Evaluation for Autism Spectrum DisorderLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Reviere study director
Vice President, Clinical Affairs
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autism, run by EarliTec Diagnostics, Inc at 9 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 21 inclusion and 18 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Change in EarliPoint Index Scores in typically developing children (time frame: 180 days). The study lists 2 primary outcomes in all. 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 NCT05675371, 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 15 Sep 2025.