ICBT for OCD in Children With Autism

NCT06582225 | Recruiting DMC

• 1 other identifier: 2023-01968-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Obsessive-Compulsive Disorder; Autism Spectrum Disorder

Keywords

Obsessive-Compulsive Disorder; Autism Spectrum Disorder; Exposure and Response Prevention; Cognitive-Behavioural Treatment; Internet; Guided self-help; Stress Management

Outcome Measures

Primary Outcomes (1)

• Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)

  The CY-BOCS is a semi-structured clinician-administered scale used to assess the severity of OCD symptoms in children and adolescents. The scale consists of a checklist of obsessions and compulsions, 10 items assessing the severity of the OCD symptoms, and a series of ancillary items (e.g., level of insight, avoidance). Range: 0-40, lower scores mean better outcome.

  Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.

Secondary Outcomes (19)

• Clinical Global Impression - Severity (CGI-S)

  Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.

• Clinical Global Impression - Improvement (CGI-I)

  Post treatment (week 12), 3-months follow-up, 6-months follow up.

• Treatment response and remission

  Post treatment (week 12), 3-months follow-up, 6-months follow up.

• Children's Global Assessment Scale (CGAS)

  Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.

• Obsessive-Compulsive Inventory - Child version - revised (OCI-CV-R)

  Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.

Other Outcomes (11)

• Demographic data - clinician-entered

  Baseline (week 0).

• Demographic data - parent-reported

  Baseline (week 0).

• Comorbid psychiatric disorders

  Baseline (week 0).

Study Arms (2)

Internet-delivered exposure and response prevention (I-ERP)

EXPERIMENTAL

A therapist-guided, internet-delivered exposure and response prevention (I-ERP) programme for children and adolescents with OCD and autism.

Behavioral: Internet-delivered exposure and response prevention (I-ERP)

Internet-delivered stress management (I-SM)

ACTIVE COMPARATOR

A therapist-guided, internet-delivered stress management (I-SM) programme for children and adolescents with OCD and autism.

Behavioral: Internet-delivered stress management (I-SM)

Interventions

Internet-delivered exposure and response prevention (I-ERP) BEHAVIORAL

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.

Internet-delivered exposure and response prevention (I-ERP)

Internet-delivered stress management (I-SM) BEHAVIORAL

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.

Internet-delivered stress management (I-SM)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A diagnosis of autism, based on the diagnostic criteria of the 4th or 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the 10th edition of the International Classification of Diseases (ICD-10). Informed by the parent/caregiver and subsequently confirmed by review of the medical record or the neurodevelopmental assessment report. A diagnosis of autism will be considered present if it was established with validated instruments, such as the Autism Diagnostic Interview-Revised (ADI-R), the Autism Diagnostic Observation Schedule (ADOS) edition 1 or 2 or the Diagnostic Interview for Social and Communication Disorders (DISCO; autism or ASD cut-offs).
• Age between 7 and 17 years. Confirmed by the caregiver and subsequently by the medical record system.

You may not qualify if:

• Global intellectual disability. Informed by the parent/caregiver and subsequently confirmed by review of the medical record or the neurodevelopmental assessment report, and additionally estimated with the two subtests matrix reasoning and similarities from the Wechsler Intelligence Scale for Children - fifth edition (WISC-V) or Wechsler Adult Intelligence Scale - fourth edition (WAIS-IV).

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Region Skane: collaborator
• Vastra Gotaland Region: collaborator

Study Sites (3)

Forskningsmottagning barn- och ungdomspsykiatri Lund

Lund, Skåne County, 222 41, Sweden

RECRUITING

Child and Adolescent Psychiatry Research Center

Stockholm, Stockholm County, 113 30, Sweden

RECRUITING

BUP Specialmottagning

Gothenburg, Västra Götalandsregionen, 411 14, Sweden

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• David Mataix-Cols

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mataix-Cols

CONTACT

+46723986889; david.mataix.cols@ki.se

Moa Warnström

CONTACT

+46768419808; moa.warnstrom@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study personnel who can be blind to study aims/hypotheses and group allocation, will be blind. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blind to study aims/hypotheses and treatment allocation for the full duration of the trial (up to the 6-month follow-up). The assessors will not receive any information about the study design, objectives or treatment conditions in order to maximise the blinding integrity. At each follow-up assessment, participants will be reminded by their assessor to not reveal details about their treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multisite parallel-group randomised controlled superiority trial.

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 3, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)