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A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)

NCT03611075

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Autism Spectrum Disorder

Interventions: No Intervention

Countries: United States, Canada, United Kingdom

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 overview

Sex: ALL

Age: 5 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (18)

Dothan, Alabama, United States
Phoenix, Arizona, United States
San Diego, California, United States
Stanford, California, United States
Jacksonville, Florida, United States
Minneapolis, Minnesota, United States
Orangeburg, New York, United States
The Bronx, New York, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Bellevue, Washington, United States
Seattle, Washington, United States
East York, Ontario, Canada
Glasgow, United Kingdom
London, United Kingdom