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).

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.

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.

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.