Clinical trial NCT05675371: Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
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).
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
EarliPoint System: Evaluation for Autism Spectrum Disorder
EarliPoint
DQSVE
Lead sponsor: EarliTec Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 332
Sex: ALL
Minimum age (years): 15
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 criteria: 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.

Primary outcomes:
measure: Change in EarliPoint Index Scores in typically developing children
timeFrame: 180 days
measure: Change in EarliPoint Index Scores in ASD/DD children
timeFrame: 180 days
Secondary outcomes:
measure: Relationship of the EarliPoint index scores to clinical reference assessments
timeFrame: 180 days
measure: Incidence of behavioral events which limit completion of an eye-tracking session.
timeFrame: 180 days
measure: Incidence of adverse device effects associated with use of the study device
timeFrame: 180 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center (SARRC)
state: Arizona
city: Glendale
country: United States
facility: Cortica - Glendale
state: California
city: San Rafael
country: United States
facility: Cortica - Marin
state: California
city: Torrance
country: United States
facility: Cortica - Torrance
state: California
city: Westlake Village
country: United States
facility: Cortica - Weslake Village
state: California
city: Atlanta
country: United States
facility: Emory University/Marcus Autism Center
state: Georgia
city: Omaha
country: United States
facility: Munroe-Meyer Institute / University of Nebraska
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: AJ Drexel Autism Institute, Drexel University
state: Pennsylvania
Study officials:
affiliation: Vice President, Clinical Affairs
name: John Reviere
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.