Internet Delivered CBT for OCD in Adolescents With ASD - A Clinical Case Series

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660099
• Other study ID #: BiP-ASD/OCD
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: September 5, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive
• Compulsive Behavior
• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Internet-delivered Cognitive Behavior Therapy
The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet platform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. Both parents and adolescents are involved in treatment. Parents will also receive three lectures on 1, Autism spectrum disorder, 2, CBT and functional analysis and 3, Parental strategies

Locations

Country	Name	City	State
Sweden	Karolinska insititute	Stockholm
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obsessional Compulsive Inventory - Child version, OCI-CV	Self-rated OCD symptom levels	Change from baseline to 12 weeks	No
Secondary	Children's Yale Brown Obsessive Compulsive Scale	Clinician-rated OCD symptom levels	Change from baseline to 12 weeks	No
Secondary	Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID	psychiatric screening of comorbidity	Baseline	No
Secondary	Clinical Global Impression - Severity, CGI-S	Global symptom levels	Change from baseline to 12 weeks	No
Secondary	Clinical Global Impression - Improvement, CGI-I	Global symptom improvement	Post treatment(12 weeks)	No
Secondary	Children's Global Assessment Scale, CGAS	Global level of functioning	Change from baseline to 12 weeks	No
Secondary	Children´s Depression Inventory - Short version	Symptom level of depressive mood	Change from baseline to 12 weeks	No
Secondary	Strength and difficulties, SDQ	General psychopathology	Change from baseline to 12 weeks	No
Secondary	Family Accommodation Scale, Parent-Report, FAS-PR	Parental accommodation to OCD symptoms	Change from baseline to 12 weeks	No
Secondary	Patient ICBT Adherence Rating, PIAR	Patient Adherence to internet delivered CBT	after 6 weeks and at post treatment(12 weeks)	No
Secondary	Education, Work and Social Adjustment Scale - child and parent version, EWSAS	Global functioning	Change from baseline to 12 weeks	No