NCT06582225

ICBT for OCD in Children With Autism

Internet-delivered Cognitive-behaviour Therapy for Obsessive- Compulsive Disorder in Children With Autism: A Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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 Children's 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 Children's 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.

Conditions

• Obsessive-Compulsive Disorder
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Internet-delivered exposure and response prevention (I-ERP)	The intervention is internet-delivered and therapist-guided, involving the child and at least one caregiver. It consists of two separate sets of modules, one for the child and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks. The treatment includes psychoeducation about ASD, OCD, emotions, healthy habits, the difference between repetitive behaviours in autism and OCD, how compulsions maintain the obsessions, and the rationale for ERP. The main focus of the treatment is ERP tasks based on the young person's individual goals. The modules also contain homework tasks that are meant to be completed between modules, mainly consisting of ERP. The final module includes a summary of the treatment and a relapse prevention plan. The version for parents consists of the same content as the child treatment, but with elaborated psychoeducation, and additional focus on strategies on how to assist their child in the different exposure tasks.
BEHAVIORAL	Internet-delivered stress management (I-SM)	The intervention is internet-delivered and therapist-guided, involving the child and at least one caregiver. It consists of two separate sets of modules, one for the child and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks. The treatment includes psychoeducation about ASD, OCD, healthy habits, and how stress is a contributor to OCD symptoms. The rationale is that targeting and reducing stress will have a beneficial impact on anxiety, obsessions, and compulsions. The main goal of the treatment is to learn how to reduce stress, mainly by using relaxation techniques such as deep breathing, progressive muscle relaxation, and imagery (cognitive) relaxation. The modules also contain homework tasks that are meant to be completed between modules, mainly consisting of relaxation tasks. The version for parents contains psychoeducation, as well as strategies on how to assist their child in the different relaxation tasks.

Timeline

• Start date: 2024-11-25
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-09-03
• Last updated: 2025-06-11

Locations

3 sites across 1 country: Sweden