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

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

  • Autism Spectrum Disorder

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 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

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
No Intervention
Typically Developing (TD) Healthy Participant Children 		Participants will be 5-12 years old
No Intervention
TD Healthy Participant Adolescents 		Participants will be 13-17 years old
No Intervention
TD Healthy Participant Adults 		Participants will be 18-45 years old

More Details

Status
Completed
Sponsor
Hoffmann-La Roche

Study Contact