Autism Spectrum DisorderNCT03123146
Cognitive Behavioural Therapy for Children With Autism Spectrum Disorder and Obsessive Compulsive Behaviour
A study testing Functional Behavior-Based Cognitive Behavioral Therapy in people with Autism Spectrum Disorder and Obsessive-Compulsive Behavior, run by Tricia Vause at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder, Obsessive-Compulsive Behavior
- What is being tested?
- Functional Behavior-Based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2010to 1 Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- participation in treatment for anxiety
- participation in treatment for repetitive behaviour
- participation in treatment for intensive behavioural intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Functional Behavior-Based Cognitive Behavioral Therapy
- Keywords
- Cognitive Behavioral Therapy
- Medical subject headings
- Autism Spectrum Disorder, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Behavior-Based Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fb-Cognitive Behavioral Therapy | Experimental | Functional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises. Receives: Behavioral: Functional Behavior-Based Cognitive Behavioral Therapy |
| Treatment as Usual (TAU) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Repetitive Behavior Scale (RBS_SCR)
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
Measured: 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)
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.
Measured: Assessment occurred at baseline and 2 weeks following end of treatment
Secondary outcomes (3)
Change in Repetitive Behavior Scale 100 (RBS_100)
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).
Measured: 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)
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).
Measured: 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.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jun 2010
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tricia Vause
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation, Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor-investigator, Tricia Vause, Brock University
- Investigators
- Tricia Vause, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123146
- Sponsor's protocol ID
- 09-066-VAUSE
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vause T, Jaksic H, Neil N, Frijters JC, Jackiewicz G, Feldman M. Functional Behavior-Based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children with Autism Spectrum Disorder: A Randomized Controlled Trial. J Autism Dev Disord. 2020 Jul;50(7):2375-2388. doi: 10.1007/s10803-018-3772-x.
PubMed 30293128
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03123146
- Acronym / sponsor ID
- 09-066-VAUSE
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tricia VauseUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation, Ontario Ministry of Health and Long Term Care
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fb-Cognitive Behavioral Therapy | Experimental | Behavioral: Functional Behavior-Based Cognitive Behavioral TherapyFunctional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises. |
| Treatment as Usual (TAU) | No intervention | –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. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- participation in treatment for anxiety
- participation in treatment for repetitive behaviour
- participation in treatment for intensive behavioural intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Behavior-Based Cognitive Behavioral TherapyFb-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. | Behavioural | Fb-Cognitive Behavioral Therapy |
Primary outcome
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
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 30293128Vause T, Jaksic H, Neil N, Frijters JC, Jackiewicz G, Feldman M. Functional Behavior-Based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children with Autism Spectrum Disorder: A Randomized Controlled Trial. J Autism Dev Disord. 2020 Jul;50(7):2375-2388. doi: 10.1007/s10803-018-3772-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tricia Vause, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Behavior-Based Cognitive Behavioral Therapy in people with Autism Spectrum Disorder and Obsessive-Compulsive Behavior, run by Tricia Vause at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.