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



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:5 - 45
Updated:3/22/2019
Start Date:August 13, 2018
End Date:August 30, 2019
Contact:Reference Study ID Number: BP40331 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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

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.


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)
We found this trial at
18
sites
San Diego, California 92108
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Austin, Texas 78759
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Dothan, Alabama 36303
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Houston, Texas 17115
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5200 Belfort Road
Jacksonville, Florida 32256
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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720 Southeast Washington Avenue
Minneapolis, Minnesota 55414
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San Antonio, Texas 78258
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Staten Island, New York 10312
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