Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582225
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
ICBT for OCD in Children With Autism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Internet-delivered Cognitive-behaviour Therapy for Obsessive- Compulsive Disorder in Children With Autism A Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate the clinical efficacy the cost-effectiveness and the effect durability of a therapist-guided internet-delivered cognitive-behavior therapy intervention for obsessive-compulsive disorder OCD in children and adolescents with autism A process evaluation of the treatment will also be conducted
Detailed Description:
Primary objective To determine the clinical efficacy of autism-adapted internet-delivered exposure with response prevention I-ERP in reducing OCD symptom severity as measured by the Childrens Yale Brown-Obsessive Compulsive Scale CY-BOCS in children and adolescents with OCD and autism spectrum disorder ASD compared with an active control intervention of high ecological validity internet-delivered stress management I-SM
Secondary objectives
1 To establish the 6-month durability of the treatment effects in a naturalistic follow-up
2 To conduct a health economic evaluation of I-ERP compared with I-SM at the primary endpoint 3-month follow-up from the health organisation payer health care sector and societal perspectives
3 To conduct a process evaluation with a subset of participants allocated to the I-ERP arm focusing on implementation mechanisms of impact and context
Type of trial A multisite parallel-group randomised controlled superiority trial with embedded health economic and process evaluation
Rationale OCD and ASD are two frequently co-occuring disorders associated with significant impairments in daily life Cognitive-behavioural therapy CBT specifically adapted to ASD is a promising treatment for this patient group but further research is needed to fully establish its efficacy Furthermore ASD-adapted CBT for OCD is a highly specialised treatment not accessible for most patients Offering treatment in a digital format could dramatically increase treatment availability for these children
Planned trial sites The study will be coordinated from the Department of Clinical Neuroscience at Karolinska Institutet the Sponsor There will be three collaborating study sites BUP OCD och relaterade tillstånd Region Stockholm BUP Specialmottagning Västra Götalandsregionen and BUP Skåne Region Skåne Each of the three sites will assess and treat participants from their own region and occasionally from adjacent regions
Trial design and methods All potential participants are initially screened via the telephone or at one of the three participating centres If screening is positive an inclusion assessment will follow Individuals who are eligible and have consented to participate in the trial will be randomised to one of two trial arms In one arm participants will receive 12 modules of therapist- and parent-guided I-ERP for OCD adapted for autism In the active comparator arm participants will receive 12 modules of therapist- and parent-guided I-SM Participants in the comparator group will be offered to cross-over to the I-ERP intervention after the primary endpoint
Participants will complete outcome measures at baseline week 0 post-treatment week 12 and 3- and 6-months post-treatment The primary outcome variable is the clinician-reported Childrens Yale Brown-Obsessive Compulsive Scale CY-BOCS and the primary endpoint is the 3-month follow-up after treatment
Secondary outcomes include measures of self-reported OCD symptoms family accommodation functional impairment and depressive symptoms Health-related quality of life and resource use will be collected for the health economic evaluation Follow-up assessments will be conducted at the clinic or via videoconferencing in both cases complemented with online questionnaires
A subset of participants will participate in a process evaluation of the I-ERP intervention
Sample A total of 220 autistic children and adolescents diagnosed with OCD and their primary caregivers
Statistical methodology and analysis Data will be analysed using a pre-specified intention-to-treat statistical analysis plan The primary outcome will be analysed using a linear mixed effects model Secondary outcomes will be analysed using analogous methods A health economic evaluation of the intervention from the health organisation payer health care sector and societal perspectives will also be conducted as well as a process evaluation including both quantitative and qualitative measures
Secondary objectives
1 To establish the 6-month durability of the treatment effects in a naturalistic follow-up
2 To conduct a health economic evaluation of I-ERP compared with I-SM at the primary endpoint 3-month follow-up from the health organisation payer health care sector and societal perspectives
3 To conduct a process evaluation with a subset of participants allocated to the I-ERP arm focusing on implementation mechanisms of impact and context
Type of trial A multisite parallel-group randomised controlled superiority trial with embedded health economic and process evaluation
Rationale OCD and ASD are two frequently co-occuring disorders associated with significant impairments in daily life Cognitive-behavioural therapy CBT specifically adapted to ASD is a promising treatment for this patient group but further research is needed to fully establish its efficacy Furthermore ASD-adapted CBT for OCD is a highly specialised treatment not accessible for most patients Offering treatment in a digital format could dramatically increase treatment availability for these children
Planned trial sites The study will be coordinated from the Department of Clinical Neuroscience at Karolinska Institutet the Sponsor There will be three collaborating study sites BUP OCD och relaterade tillstånd Region Stockholm BUP Specialmottagning Västra Götalandsregionen and BUP Skåne Region Skåne Each of the three sites will assess and treat participants from their own region and occasionally from adjacent regions
Trial design and methods All potential participants are initially screened via the telephone or at one of the three participating centres If screening is positive an inclusion assessment will follow Individuals who are eligible and have consented to participate in the trial will be randomised to one of two trial arms In one arm participants will receive 12 modules of therapist- and parent-guided I-ERP for OCD adapted for autism In the active comparator arm participants will receive 12 modules of therapist- and parent-guided I-SM Participants in the comparator group will be offered to cross-over to the I-ERP intervention after the primary endpoint
Participants will complete outcome measures at baseline week 0 post-treatment week 12 and 3- and 6-months post-treatment The primary outcome variable is the clinician-reported Childrens Yale Brown-Obsessive Compulsive Scale CY-BOCS and the primary endpoint is the 3-month follow-up after treatment
Secondary outcomes include measures of self-reported OCD symptoms family accommodation functional impairment and depressive symptoms Health-related quality of life and resource use will be collected for the health economic evaluation Follow-up assessments will be conducted at the clinic or via videoconferencing in both cases complemented with online questionnaires
A subset of participants will participate in a process evaluation of the I-ERP intervention
Sample A total of 220 autistic children and adolescents diagnosed with OCD and their primary caregivers
Statistical methodology and analysis Data will be analysed using a pre-specified intention-to-treat statistical analysis plan The primary outcome will be analysed using a linear mixed effects model Secondary outcomes will be analysed using analogous methods A health economic evaluation of the intervention from the health organisation payer health care sector and societal perspectives will also be conducted as well as a process evaluation including both quantitative and qualitative measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None