NCT03123146

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

April 13, 2017

Last Update Submit

April 19, 2017

Conditions

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Assessment occurred at baseline and 2 weeks following end of treatment

Secondary Outcomes (3)

  • Change in Repetitive Behavior Scale 100 (RBS_100)

    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)

    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.

    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)

Study Arms (2)

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.

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.

Interventions

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.

Fb-Cognitive Behavioral Therapy

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderCompulsive Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersImpulsive BehaviorBehavior

Study Officials

  • Tricia Vause, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 21, 2017

Study Start

June 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations