Clinical trial NCT03611075: A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
Official title: Study to Evaluate and Explore Scales for Repetitive and Restricted Behaviors and Digital Biomarkers in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 144
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) - Total Score
timeFrame: Baseline, Weeks 2 and 12
measure: Montefiore Einstein Rigidity Scale (MERS-R)
timeFrame: Baseline, Weeks 2 and 12
measure: Repetitive Behavior Scale-Revised (RBS-R)
timeFrame: Baseline, Weeks 2 and 12
measure: Repetitive Behavior Questionnaire for Children (RBQ-2)
timeFrame: Baseline, Weeks 2 and 12
measure: Restricted Behavior Questionnaire for Adults (RBQ-2A)
timeFrame: Baseline, Weeks 2 and 12
measure: Childhood Routines Inventory-Revised (CRI-R)
timeFrame: Baseline, Weeks 2 and 12
measure: Adult Routines Inventory (ARI)
timeFrame: Baseline, Weeks 2 and 12
Secondary outcomes:
measure: Clinical Global Impression Scales (CGI)
timeFrame: Baseline, Weeks 2 and 12
measure: Child's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, Weeks 2 and 12
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline, Weeks 2 and 12
measure: Reading the Mind in the Eyes Test -R (RMET-R)
timeFrame: Baseline, Week 12
measure: Reading the Mind in the Eyes Test Child -C (RMET-C)
timeFrame: Baseline, Week 12
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline, Weeks 2 and 12
measure: Parent Rated Anxiety Scale for ASD (PRAS-ASD)
timeFrame: Baseline, Weeks 2 and 12
measure: Beck Anxiety Index (BAI)
timeFrame: Baseline, Weeks 2 and 12
measure: Digital Biomarkers
timeFrame: Baseline until study completion (approximately 12 weeks)
measure: Behaviour Rating Inventory of Executive Function for Children (BRIEF)
timeFrame: Baseline, Weeks 2 and 12
measure: Behaviour Rating Inventory of Executive Function for Adults (BRIEF-A)
timeFrame: Baseline, Weeks 2 and 12
measure: Short Sensory Profile (SSP)
timeFrame: Baseline, Weeks 2 and 12
measure: Vineland(TM)-II Survey
timeFrame: Baseline, Week 12
measure: Pediatric Quality of Life Inventory (PedsQL) Family Impact Scale
timeFrame: Baseline, Weeks 2 and 12
measure: PedsQL Core Functioning Scale
timeFrame: Baseline, Weeks 2 and 12
measure: PedsQL Cognitive Functioning Scale
timeFrame: Baseline, Week 2 and 12
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: San Diego
country: United States
facility: PCSD Feighner Research
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc; Jacksonville Clinic
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota; Clin. Neuro Research Unit
state: Minnesota
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Orangeburg
country: United States
facility: Nathan S. Kline Institute for Psychiatric Research
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Austin
country: United States
facility: BioBehavioral Research of Austin, PC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research Ltd
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center - ClinEdge - PPDS
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital - PIN; Investigational Drug Services
state: Washington
city: East York
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre
state: Ontario
city: Glasgow
country: United Kingdom
facility: Gartnavel Royal Hospital; Mental Health & Wellbeing
city: London
country: United Kingdom
facility: Kings College London
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: