Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder

Karolinska Institutet1 site in 1 country22 target enrollmentMarch 9, 2018

ConditionsObsessive-Compulsive Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obsessive-Compulsive Disorder
Sponsor: Karolinska Institutet
Enrollment: 22
Locations: 1
Primary Endpoint: Children's Yale-Brown Obsessive Compulsive Scale
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.

Detailed Description

The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.

Registry

clinicaltrials.gov

Start Date

March 9, 2018

End Date

February 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Fabian Lenhard

PhD, Principal Investigator

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

•a diagnosis of OCD according to DSM-5
•a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
•a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
•age between 7 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

•a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
•comorbid hoarding disorder or OCD with hoarding as a principal symptom.
•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 any anxiety disorder
•OCD treatment is not an immediate priority

Outcomes

Primary Outcomes

Children's Yale-Brown Obsessive Compulsive Scale

Time Frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment

Changein obsessions and compulsions will be measured as the total score on the scale.. Total score ranges from 0 to 40 points, a higher score indicates more severe OCD. The scale is rated by a clinician.

Secondary Outcomes

Obsessive-compulsive inventory - child version(Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Education, work and social adjustment scale - child and parent version(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Family accommodation scale for obsessive-compulsive disorder(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Mood and Feeling Questionnaire - child and parent version(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Mini International Neuropsychiatric Interview for Children and Adolescents(Baseline)
Children's global assessment scale(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Clinical global impression - severity(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Children's Assessment Scale for Developmental Disabilities(Baseline)
Autism spectrum quotient (AQ-10)(Baseline)
Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)(Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Completed treatment modules(week 16)
Clinical global impression - improvement(16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
Client Satisfaction Questionnaire (CSQ-8)(16 weeks)
Parent strategies(Post-treatment)
Drop-out rate from treatment(at week 16)
internet intervention Patient Adherence Scale(8 weeks, 16 weeks)
Patient EX/RP Adherence Scale(Weekly for 16 weeks (during treatment))