Back to resultsAn eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet CBT
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, ASD, Obsessive Compulsive Disorder, Autism Spectrum Disorder, ICBT, eHealth, Internet, CBT, Pediatric, Adolescents, Children, Internet-delivered
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
Sites / Locations
- BUP OCD and Related Disorders
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Internet CBT
Arm Description
Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Obsessive-compulsive inventory - child version
Child-rating of OCD symptoms. The total score range is 0-42, a higher score indicates more OCD-symptoms.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Drop-out rate from treatment
Percentage of patients that drop out from ICBT
Completed treatment modules
Number of completed treatment modules
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473080
Brief Title
An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
Official Title
Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, ASD, Obsessive Compulsive Disorder, Autism Spectrum Disorder, ICBT, eHealth, Internet, CBT, Pediatric, Adolescents, Children, Internet-delivered
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet CBT
Arm Type
Other
Arm Description
Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support.
Intervention Type
Behavioral
Intervention Name(s)
Internet CBT
Other Intervention Name(s)
ICBT, Internet-delivered Cognitive Behavior Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Children's Yale-Brown Obsessive Compulsive Scale
Description
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 Outcome Measure Information:
Title
Obsessive-compulsive inventory - child version
Description
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
Title
Autism spectrum quotient (AQ-10)
Description
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
Title
Education, work and social adjustment scale - child and parent version
Description
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
Title
Family accommodation scale for obsessive-compulsive disorder
Description
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
Title
Mood and Feeling Questionnaire - child and parent version
Description
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
Title
Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)
Description
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
Title
Mini International Neuropsychiatric Interview for Children and Adolescents
Description
Clinician-rated, a semi-structured interview to asses psychiatric problems in children. Results will be presented as co-morbid psychiatric diagnoses.
Time Frame
Baseline
Title
Children's global assessment scale
Description
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
Title
Children's Assessment Scale for Developmental Disabilities
Description
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
Title
Clinical global impression - severity
Description
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
Title
Clinical global impression - improvement
Description
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
Title
internet intervention Patient Adherence Scale
Description
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
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
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
Title
Parent strategies
Description
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
Title
Patient EX/RP Adherence Scale
Description
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)
Title
Drop-out rate from treatment
Description
Percentage of patients that drop out from ICBT
Time Frame
at week 16
Title
Completed treatment modules
Description
Number of completed treatment modules
Time Frame
week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabian Lenhard, PhD
Organizational Affiliation
Karolinska Institutet, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUP OCD and Related Disorders
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden
12. IPD Sharing Statement
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An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
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