A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: No Intervention
Intervention description: No interventions are administered in this study
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 5 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a non-drug study seeking to characterize different scales to measure repetitive and
      restrictive behaviors in different ASD sub-populations over time. This study will also
      explore the use of digital biomarkers.
    

Eligibility criteria:

        Inclusion Criteria for All Participants

          -  Males and females

          -  Availability of a parent or other reliable caregiver. The same person must agree to
             accompany the participant to all clinic visits and provide information about the
             participant's behavior and symptoms

        Inclusion Criteria for Participants with Autism Spectrum Disorders (ASD)(Diagnostic
        evaluations will be completed at study site by research staff and supervised by a licensed
        psychologist)

          -  Age: 5-45 years

          -  Diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders
             (DSM-5), and the Autism Diagnostic Observation Schedule (ADOS-2).

          -  Children's Yale-Brown Obsessive Compulsive Scale modified for ASD (CY-BOCS-ASD) total
             score of at least 12

          -  Clinical Global Impression-Severity (CGI-S) scale of at least 4 about participant's
             current autism severity

          -  Intelligence quotient (IQ) score of 50 or above as assessed by the Abbreviated
             Intelligence Quotient (ABIQ) SB5 scale

          -  All medications and treatments are expected to be stable for the duration of the study

        Inclusion Criteria for Typically Developing (TD) Healthy Participants

        -TD participants aged 5-45 years

        Exclusion Criteria for All Participants

          -  Participation in an in investigational drug or device study within 4 weeks or 5 times
             the half-life of the investigational molecule prior to screening, and participant is
             not expected to enroll in any other trial during the study

          -  Co-occurring disease, condition, or treatment that might interfere with the conduct of
             the study or pose an unacceptable risk to the participant

          -  Unstable or uncontrolled clinically significant psychiatric and/or neurological
             disorder that may interfere with study objectives

        Exclusion Criteria for Participants with ASD -Known "syndromic" ASD (e.g. Fragile X
        syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q
        syndrome) History of alcohol misuse and/or illicit drug use during the last 12 months of
        the study

        Exclusion Criteria for TD Healthy Participants

        -TD healthy participants with a first-degree relative with ASD