- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473080
An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
July 2, 2021 updated by: Fabian Lenhard, Karolinska Institutet
Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, 11330
- BUP OCD and Related Disorders
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: Internet CBT
Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Obsessive-compulsive inventory - child version
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
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Child-rating of OCD symptoms.
The total score range is 0-42, a higher score indicates more OCD-symptoms.
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Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Autism spectrum quotient (AQ-10)
Time Frame: Baseline
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Parent-rated, brief screeing for symtoms relating to autism spectrum disorder.
Total score ranges from 0-10, a higher score indicating more symtoms.
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Baseline
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Education, work and social adjustment scale - child and parent version
Time Frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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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.
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Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Family accommodation scale for obsessive-compulsive disorder
Time Frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Parent-rated scale, total score ranges from 0 to 76, a higher score indicates more family accommodation to the child's OCD.
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Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Mood and Feeling Questionnaire - child and parent version
Time Frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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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.
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Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)
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
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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.
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Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Mini International Neuropsychiatric Interview for Children and Adolescents
Time Frame: Baseline
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Clinician-rated, a semi-structured interview to asses psychiatric problems in children.
Results will be presented as co-morbid psychiatric diagnoses.
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Baseline
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Children's global assessment scale
Time Frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Clinician-rated, measures the childs global psychiatric functioning.
Total score ranges from 0-100, a lower score indicates lower functioning.
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Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Children's Assessment Scale for Developmental Disabilities
Time Frame: Baseline
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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.
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Baseline
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Clinical global impression - severity
Time Frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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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.
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Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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Clinical global impression - improvement
Time Frame: 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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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.
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16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
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internet intervention Patient Adherence Scale
Time Frame: 8 weeks, 16 weeks
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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.
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8 weeks, 16 weeks
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Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 16 weeks
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Self-rated and parent-rated.
Measures level of satisfaction with the treatment.
Total score ranges from 8 to 32, higher level indicates higher satisfaction.
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16 weeks
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Parent strategies
Time Frame: Post-treatment
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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
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Post-treatment
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Patient EX/RP Adherence Scale
Time Frame: Weekly for 16 weeks (during treatment)
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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.
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Weekly for 16 weeks (during treatment)
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Drop-out rate from treatment
Time Frame: at week 16
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Percentage of patients that drop out from ICBT
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at week 16
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Completed treatment modules
Time Frame: week 16
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Number of completed treatment modules
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week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabian Lenhard, PhD, Karolinska Institutet, Stockholm, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 9, 2018
Primary Completion (ACTUAL)
February 15, 2021
Study Completion (ACTUAL)
February 15, 2021
Study Registration Dates
First Submitted
February 16, 2018
First Submitted That Met QC Criteria
March 14, 2018
First Posted (ACTUAL)
March 22, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 6, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIP ASD/OCD pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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