Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
- Conditions
- Autism Spectrum DisorderAutismDevelopmental DelayAutism, Early InfantileAutism, Infantile
- Interventions
- Behavioral: Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)Device: Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
- Registration Number
- NCT05675371
- Lead Sponsor
- EarliTec Diagnostics, Inc
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 332
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1a - Typically developing (ages 16-30 months) Assessment by the EarliPoint Assessment For Autism Spectrum Disorder Typically developing toddlers ages 16 - 30 months (chronological age). 1a - ASD/DD (ages 16-30 months) Assessment by the EarliPoint Assessment For Autism Spectrum Disorder 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) Assessment by Expert Clinician During Behavioral Intervention (ABA or similar) Typically developing children ages 31-84 months (chronological age). 1a - Typically developing (ages 16-30 months) Assessment by Expert Clinician During Behavioral Intervention (ABA or similar) Typically developing toddlers ages 16 - 30 months (chronological age). 1a - ASD/DD (ages 16-30 months) Assessment by Expert Clinician During Behavioral Intervention (ABA or similar) 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) Assessment by the EarliPoint Assessment For Autism Spectrum Disorder Typically developing children ages 31-84 months (chronological age). 1b - ASD/DD (ages 31-84 months) Assessment by Expert Clinician During Behavioral Intervention (ABA or similar) Children ages 31-84 months with autism spectrum disorder and/or related developmental delay who are undergoing applied behavioral analysis (ABA) or related therapies. 1b - ASD/DD (ages 31-84 months) Assessment by the EarliPoint Assessment For Autism Spectrum Disorder Children ages 31-84 months with autism spectrum disorder and/or related developmental delay who are undergoing applied behavioral analysis (ABA) or related therapies.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.
Trial Locations
- Locations (9)
Southwest Autism Research and Resource Center (SARRC)
🇺🇸Phoenix, Arizona, United States
Cortica - Glendale
🇺🇸Glendale, California, United States
Cortica - Marin
🇺🇸San Rafael, California, United States
Cortica - Torrance
🇺🇸Torrance, California, United States
Cortica - Weslake Village
🇺🇸Westlake Village, California, United States
Emory University/Marcus Autism Center
🇺🇸Atlanta, Georgia, United States
Munroe-Meyer Institute / University of Nebraska
🇺🇸Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
AJ Drexel Autism Institute, Drexel University
🇺🇸Philadelphia, Pennsylvania, United States