Autism, Autism, Early Infantile, Autism, Infantile, Autism Spectrum Disorder, Developmental Delay
Conditions
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
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.
Interventions
BEHAVIORALAssessment by Expert Clinician During Behavioral Intervention (ABA or similar)
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
DEVICEAssessment by the EarliPoint 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.
Sponsors
EarliTec Diagnostics, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Months to 84 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in EarliPoint Index Scores in typically developing children | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship of the EarliPoint index scores to clinical reference assessments | 180 days | 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. |
| Incidence of behavioral events which limit completion of an eye-tracking session. | 180 days | 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. |
| Incidence of adverse device effects associated with use of the study device | 180 days | To estimate the incidence of adverse device effects associated with the use of the study device. |
Countries
United States
Outcome results
None listed