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CompletedNCT03123146Updated Apr 21, 2017

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
7 Years to 13 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Autism Spectrum Disorder
  • Obsessive-Compulsive Behavior

Keywords

  • Cognitive Behavioral Therapy
03

Who can participate

Ages eligible
7 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • participation in treatment for anxiety
  • participation in treatment for repetitive behaviour
  • participation in treatment for intensive behavioural intervention
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralFunctional 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.

05

What researchers measure

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

06

Study locations

1 site
  • Brock University
    St Catharines, Ontario L2S3A1, Canada
07

References and documents

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 ↗
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Registry details

Key details

Study ID
NCT03123146
Lead sponsor
Tricia Vause
Collaborators
Ontario Mental Health Foundation, Ontario Ministry of Health and Long Term Care
Responsible party
Tricia Vause (Associate Professor, Brock University) — Sponsor-investigator
First posted
Apr 21, 2017
Start date
Jun 1, 2010
Primary completion
Feb 1, 2014
Completion
Feb 1, 2014
Last update
Apr 21, 2017

Study contacts

Tricia Vause, PhD
principal investigator · Brock University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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