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

Karolinska Institutet22 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

Internet CBTBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

BUP OCD and Related Disorders

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Obsessive-compulsive inventory - child version

Child-rating of OCD symptoms. The total score range is 0-42, a higher score indicates more OCD-symptoms.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: Weekly for 16 weeks (during treatment)

Drop-out rate from treatment

Percentage of patients that drop out from ICBT

Time frame: at week 16

Completed treatment modules

Number of completed treatment modules

Time frame: week 16