Cognitive Behavioural Therapy for Children With Autism Spectrum Disorder and Obsessive Compulsive Behaviour

April 19, 2017 updated by: Tricia Vause

Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial

Individuals with high functioning autism spectrum disorder (ASD) frequently experience obsessions and/or compulsions that are similar to those specified in Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive disorder (OCD). However, little research exists on effective interventions for OCD symptoms (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response prevention) as well as function-based behavioral assessment will be evaluated. Participants will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary outcome measures will be used to evaluate the efficacy of the treatment, and will be administered at pre and post-intervention as well as six month follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • St Catharines, Ontario, Canada, L2S3A1
        • Brock University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous diagnosis of ASD
  • Presence of OCBs as defined by Sameness, Ritualistic and Compulsive subscales on the RBS-R
  • a Full Scale IQ (WISC-IV; Wechsler, 2004) ≥ 70
  • parent indicated no planned change in child medication during the study (unless the physician deemed the change medically necessary)

Exclusion Criteria:

  • participation in treatment for anxiety
  • participation in treatment for repetitive behaviour
  • participation in treatment for intensive behavioural intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fb-Cognitive Behavioral Therapy
Functional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
Behavioral: Functional Behavior-Based Cognitive Behavioral Therapy
Fb-CBT involved nine 2-hour weekly sessions with three to four children in each group and two therapists. Therapy consisted of group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
No Intervention: Treatment as Usual (TAU)
Children assigned to this condition received "usual care," meaning that they could continue with any services. This group acted as a control group whereby access to intervention was patient-directed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Repetitive Behavior Scale (RBS_SCR)
Time Frame: Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)
The RBS is a 43-item parent rating measure of repetitive behavior. It is comprised of a four-point Likert scale ranging from (0) behavior does not occur, to (3) behavior occurs and is a severe problem . The RBS_SCR scale specifically focusses on the assessment of sameness, compulsive, and ritualistic behaviors
Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time Frame: Assessment occurred at baseline and 2 weeks following end of treatment
A 10-item, semi-structured interview used to assess symptom severity for children ages 6 through 17 years. Each item is rated on a 5-point ordinal scale from 0 (none) to 4 (extreme)' For the purpose of this study, only the 5-item Compulsion score was used pre and post-treatment.
Assessment occurred at baseline and 2 weeks following end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Repetitive Behavior Scale 100 (RBS_100)
Time Frame: Assessment occurred at baseline and 2 weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment)
The final item on the RBS-R asks caregivers to rate on a scale from 1 to 100 how much OCBs affect the child and the people around them (1 is not a problem to 100 is as bad as can be imagined; Bodfish et al., 1999).
Assessment occurred at baseline and 2 weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment)
Change in The child Obsessive-Compulsive Impact Scale-Revised (COIS-R)
Time Frame: Assessment occurred at baseline and 2-weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment)
A 33-item, parent-report questionnaire that assesses OCD-related impairment in various areas of the child's life, including school, social, and home/family activities. For each item, the parent rates the child's level of impairment on a 4-point Likert scale from 0 (not at all) to 3 (very much).
Assessment occurred at baseline and 2-weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment)
Parent OCB Rating Scale.
Time Frame: Scale was completed by parents at baseline, each day throughout the 9-week treatment period, and at follow-up (6 months following the cessation of treatment)
A Likert-type scale ranging from 1 (desired post-treatment levels of OCBs) to 3 (partial improvement from pre-treatment levels) to 5 (pre-treatment levels of OCBs) was used by parents to rate OCBs.
Scale was completed by parents at baseline, each day throughout the 9-week treatment period, and at follow-up (6 months following the cessation of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tricia Vause

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ontario Ministry of Health and Long Term Care
Ontario Mental Health Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tricia Vause, PhD, Brock University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-066-VAUSE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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