Purpose

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.

Condition

Eligibility

Eligible Ages
Between 5 Years and 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Healthy Volunteers

-Children ages 5-12 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 Healthy Volunteers

-Healthy children with a brother or sister with ASD (first-degree sibling)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low-Functioning Autism Spectrum Disorder (ASD) Children
Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
  • Other: No Intervention
    No interventions are administered in this study
Experimental
High-Functioning ASD Children
Participants will be 5-12 years old, with IQ scores of 70 or above
  • Other: No Intervention
    No interventions are administered in this study
Experimental
Low-Functioning ASD Adolescents
Participants will be 13-17 years old, with IQ scores between 50-70
  • Other: No Intervention
    No interventions are administered in this study
Experimental
High-Functioning ASD Adolescents
Participants will be 13-17 years old, with IQ scores of 70 or above
  • Other: No Intervention
    No interventions are administered in this study
Experimental
Low-Functioning ASD Adults
Participants will be 18-45 years old, with IQ scores between 50-70
  • Other: No Intervention
    No interventions are administered in this study
Experimental
High-Functioning ASD Adults
Participants will be 18-45 years old, with IQ scores of 70 or above
  • Other: No Intervention
    No interventions are administered in this study
Active Comparator
Healthy Participants
Participants will be 5-12 years old
  • Other: No Intervention
    No interventions are administered in this study

Recruiting Locations

Albert Einstein College of Medicine
Bronx, New York 10467

More Details

NCT ID
NCT03611075
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BP40331 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.