Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).

Detailed Description
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The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.

Official Title
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Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Internet-delivered Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary DSM-5 diagnosis of OCD Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Age between 7-11 years Ability to understand Swedish Daily access to the Internet A parent that can co-participate in the treatment Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability Suicidal ideation Not able to understand the basics of the ICBT self-help material Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention) On-going psychological treatment for OCD or another anxiety disorder

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered Cognitive-Behavioral Therapy<br> | Behavioral: Internet-delivered Cognitive Behavioral Therapy<br>* The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children´s Yale Brown Compulsive Scale (CY-BOCS) | Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended | week 0, week 12, at 3 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Global Assessment Scale (C-GAS) |  | week 0, week 12, at 3 months follow up | 
| Clinical Global Impression - Severity (CGI-S) |  | week 0, week 12, at 3 months follow up | 
| Clinical Global Impression - Improvement (CGI-I) |  | week 12, at 3 months follow up | 
| Obsessive-Compulsive Inventory - Child Version (OCI-CV) |  | week 0, week 12, at 3 months follow up and weekly during treatment | 
| Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P) |  | week 0, week 12, at 3 months follow up and weekly during treatment | 
| Family Accommodation Scale - Self Rated (FAS-SR) |  | week 0, week 12, at 3 months follow up | 
| Euroqol - Youth (EQ-5D-Y) |  | week 0, week 12, at 3 months follow up | 
| Autism Spectrum Quotient (AQ-10) |  | week 0 | 
| Education, Work and Social Adjustment Scale - child and parent version (EWSAS) |  | week 0, week 12, at 3 months follow up | 
| Child Depression Inventory - Short version (CDI-S) |  | week 0, week 12, at 3 months follow up | 
| Mood and Feeling Questionnaire - parent version (MFQ) |  | week 0, week 12, at 3 months follow up | 
| Qualitative data on treatment credibility |  | week 3 | 
| Qualitative data on treatment satisfaction |  | week 12 | 
| Safety Monitoring Uniform Report Form (SMURF) |  | week 6, week 12 | 
| Internet Intervention Patient Adherence Scale (iiPAS) |  | week 6, week 12 | 
| Patient Exposure/Response prevention Adherence Scale (PEAS) |  | week 6, week 12 |