An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Internet CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 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 |
| --- | --- |
| Other: Internet CBT<br>Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support. | Behavioral: Internet CBT<br>* The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.<br>* Other names: Internet-delivered Cognitive Behavior Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Yale-Brown Obsessive Compulsive Scale | 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. | Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and Feeling Questionnaire - child and parent version | Self-rated and parent-rated. Measures depressive symptoms in the child. Total score ranges from 0 to 26, a higher score indicates more depressive symptoms. | Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment | 
| Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P) | Parent-rated. Consists of 4 Subscales. Obsessive symptoms, Compulsive symtoms, Obsessive impairment and Compulsive impairment. The symptom subscales range from 10 to 30 points, a higher score indicating more symptomology. These subscales are added to get a total score for OCD-symptoms. The score of each impairment subscales ranges from 0 to 24, a higher score indicating more impairment. The score of the impairment subscales are added to get a total score of impairment. The symptom subscales will only be administered at baseline. The impairment subscales will be administered at all assessment points. | Baseline, weekly during treatment, 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 | Clinician-rated, a semi-structured interview to asses psychiatric problems in children. Results will be presented as co-morbid psychiatric diagnoses. | Baseline | 
| Children's global assessment scale | Clinician-rated, measures the childs global psychiatric functioning. Total score ranges from 0-100, a lower score indicates lower functioning. | 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 | Clinician-rated. measures the childs global functioning with respect to developmental disabilities. Total score ranges from 0 to 100, a lower score indicates lower functioning. | Baseline | 
| Clinical global impression - severity | Clinician-rated level of psychiatric severity, the score ranges from 1 to 7, a lower score indicates less severity. In this study the measure will only refer to level of OCD. | Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment | 
| Clinical global impression - improvement | Clinician-rated level of psychiatric improvement, the score ranges from 1 to 7, a lower score indicates more improvement. In this study the measure will only refer to level of OCD. | 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment | 
| internet intervention Patient Adherence Scale | Clinician-rated, measures the patients adherence to treatment. The scale consist of 5 items measuring 1. If the patient is in phase with treatment, 2, level of engagement in treatment 3, level of communication with the clinician, 4 motivation to change 5, frequency of log-ins to the internet-treatment. Total score ranges from 0 to 20, a higher score indicates more adherence to the treatment. | 8 weeks, 16 weeks | 
| Client Satisfaction Questionnaire (CSQ-8) | Self-rated and parent-rated. Measures level of satisfaction with the treatment. Total score ranges from 8 to 32, higher level indicates higher satisfaction. | 16 weeks | 
| Parent strategies | A parent-rated questionnaire consisting of 4 items measuring the parents 1, participation in treatment, 2, cooperation with the child during treatment, 3, autonomus support in treatment and 4, directiveness in treatment. The questions are qualitative and results will be presented on an item level | Post-treatment | 
| Patient EX/RP Adherence Scale | Self-rated questionnaire. Consist of 3 items: 1, percentage of attempted exposure exercises, 2, how well exposures were performed and 3, percentatge of respons-prevention during the last week. The answers will be presented on an item level. | Weekly for 16 weeks (during treatment) | 
| Drop-out rate from treatment | Percentage of patients that drop out from ICBT | at week 16 | 
| Completed treatment modules | Number of completed treatment modules | week 16 | 
| Obsessive-compulsive inventory - child version | Child-rating of OCD symptoms. The total score range is 0-42, a higher score indicates more OCD-symptoms. | Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment | 
| Autism spectrum quotient (AQ-10) | Parent-rated, brief screeing for symtoms relating to autism spectrum disorder. Total score ranges from 0-10, a higher score indicating more symtoms. | Baseline | 
| Education, work and social adjustment scale - child and parent version | Self-rated and parent-rated. Ranges from 0 to 40 points, a higher score indicating more problems. Measures how much the psychiatric problems affect daily life in different areas. | 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 | Parent-rated scale, total score ranges from 0 to 76, a higher score indicates more family accommodation to the child's OCD. | Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, ASD, Obsessive Compulsive Disorder, Autism Spectrum Disorder, ICBT, eHealth, Internet, CBT, Pediatric, Adolescents, Children, Internet-delivered