An interventional study of Functional Behavior-Based Cognitive Behavioral Therapy in Autism Spectrum Disorder and Obsessive-Compulsive Behavior, sponsored by Tricia Vause. Completed at 1 site in Canada. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by Tricia Vause · Not applicable, Interventional, and Treatment
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's enrollment of 37 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →This is the only study on the registry with Tricia Vause as lead sponsor.
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Exclusion Criteria:
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
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.
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.
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
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)
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.
Time frame: Assessment occurred at baseline and 2 weeks following end of treatment
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).
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)
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).
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.
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.
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)
Ran from Jun 2010 to primary completion in Feb 2014, 44 months.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 44 months is above that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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