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

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ClinicalTrials.gov Identifier: NCT03611075
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: No Intervention Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  2. Montefiore Einstein Rigidity Scale (MERS-R) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  3. Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  4. Restricted Behavior Questionnaire for Children (RBQ-2) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  5. Restricted Behavior Questionnaire for Adults (RBQ-2A) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  6. Childhood Routines Inventory-Revised (CRI-R) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  7. Adult Routines Inventory (ARI) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]

Secondary Outcome Measures :
  1. Clinical Global Impression Scales (CGI) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  2. Child's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  3. Pittsburg Sleep Quality Index (PSQI) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  4. Reading the Mind in the Eyes Test (RMET) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  5. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  6. Parent Rated Anxiety Scale for ASD (PRAS-ASD) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  7. Beck Anxiety Index (BAI) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  8. Digital Biomarkers [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
    Participants will use a dedicated smartphone and wearable device to perform at-home exploratory measures such as surveys and performance outcome measures related to autism-associated symptoms, as well as continuous passive monitoring of participant behavior.

  9. Behaviour Rating Inventory of Executive Function for Children (BRIEF) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  10. Behaviour Rating Inventory of Executive Function for Adults (BRIEF-A) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  11. Short Sensory Profile (SSP) [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
    The SSP is a caregiver-reported questionnaire regarding the effect of sensory processing anomalies on daily function.

  12. Vineland(TM)-II Survey [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  13. Pediatric Quality of Life Inventory (PedsQL) Family Impact Scale [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  14. PedsQL Core Functioning Scale [ Time Frame: Baseline until study completion (approximately 12 weeks) ]
  15. PedsQL Cognitive Functioning Scale [ Time Frame: Baseline until study completion (approximately 12 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611075


Contacts
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

Locations
United States, Arizona
Southwest Autism Research & Resource Center Recruiting
Phoenix, Arizona, United States, 85006
United States, California
David Geffen School of Medicine at UCLA Not yet recruiting
Los Angeles, California, United States, 90095-6984
PCSD Feighner Research Recruiting
San Diego, California, United States, 92108
Stanford University School of Medicine Not yet recruiting
Stanford, California, United States, 94305
United States, Georgia
Emory Autism Center; The Justin Tyler Truax Building Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Minnesota
University of Minnesota; Clin. Neuro Research Unit Recruiting
Minneapolis, Minnesota, United States, 55414
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Nathan S. Kline Institute for Psychiatric Research Recruiting
Orangeburg, New York, United States, 10962
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Northwest Clinical Research Center - ClinEdge - PPDS Not yet recruiting
Bellevue, Washington, United States, 98007
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre Not yet recruiting
East York, Ontario, Canada, M4G 1R8
United Kingdom
Gartnavel Royal Hospital; Mental Health & Wellbeing Not yet recruiting
Glasgow, United Kingdom, G12 0XH
Kings College London Not yet recruiting
London, United Kingdom, WC2R 2LS
The Newcastle upon Tyne Hospitals NHS Foundation Trust Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03611075     History of Changes
Other Study ID Numbers: BP40331
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders