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Clinical Trials/NCT02660099
NCT02660099
Completed
Not Applicable

Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series

Karolinska Institutet2 sites in 1 country4 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive Compulsive Disorder
Sponsor
Karolinska Institutet
Enrollment
4
Locations
2
Primary Endpoint
Obsessional Compulsive Inventory - Child version, OCI-CV
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). This feasibility study will inform us how to adapt the original intervention to the specific needs of patients with ASD.

Detailed Description

To evaluate the effectiveness of ICBT for OCD in adolescents with ASD, this study will use a single case experimental design with weekly measures during two phases: A-B. The A-phase will consist of baseline measures at least three weeks prior to treatment. The B-phase will consist of the 12 weeks ICBT-program as well as one measure post-treatment. Single case descriptions of each participant will be presented. Weekly measures on the Obsessional Compulsive Inventory - Child version (OCI-CV) will be analyzed through visual inspection of each participants graph and through computation of Percentage of Non-overlapping Data (PND). PND is a frequently used effect measure in SCED and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase. To assess the feasibility and comprehension of the ICBT treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of ICBT and semi-weekly during the rest of the treatment. Detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the ICBT protocol to better suit patients with ASD.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eva Serlachius

Research director

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • a diagnosis of OCD as defined by DSM-5 \[40\]
  • a diagnosis of autism defined by DSM-5
  • a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS \[14\]
  • age between 12 and 17 years
  • ability to read and write Swedish
  • access to the internet
  • a parent that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria

  • psychosis or bipolar disorder, severe eating disorder
  • suicidal ideation
  • subject not able to read or understand the basics of the ICBT material
  • completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
  • ongoing psychological treatment for OCD or another anxiety disorder

Outcomes

Primary Outcomes

Obsessional Compulsive Inventory - Child version, OCI-CV

Time Frame: Change from baseline to 12 weeks

Self-rated OCD symptom levels

Secondary Outcomes

  • Children's Yale Brown Obsessive Compulsive Scale(Change from baseline to 12 weeks)
  • Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID(Baseline)
  • Clinical Global Impression - Severity, CGI-S(Change from baseline to 12 weeks)
  • Clinical Global Impression - Improvement, CGI-I(Post treatment(12 weeks))
  • Children's Global Assessment Scale, CGAS(Change from baseline to 12 weeks)
  • Children´s Depression Inventory - Short version(Change from baseline to 12 weeks)
  • Strength and difficulties, SDQ(Change from baseline to 12 weeks)
  • Family Accommodation Scale, Parent-Report, FAS-PR(Change from baseline to 12 weeks)
  • Patient ICBT Adherence Rating, PIAR(after 6 weeks and at post treatment(12 weeks))
  • Education, Work and Social Adjustment Scale - child and parent version, EWSAS(Change from baseline to 12 weeks)

Study Sites (2)

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