Internet therapy for OCD in children with autism

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

This study is testing an online therapy program to see if it can help children with autism and OCD feel better by reducing their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 7 Years to 17 Years
• Sex: All
• Sponsor: Karolinska Institutet (Academic / other)
• Locations: 3 sites (Lund, Skåne County and 2 other locations)
• Trial ID: NCT06582225 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and cost-effectiveness of a therapist-guided, internet-delivered cognitive-behavior therapy intervention specifically designed for children and adolescents with obsessive-compulsive disorder (OCD) and autism spectrum disorder (ASD). The primary goal is to reduce OCD symptoms using an adapted exposure and response prevention (I-ERP) approach, compared to an active control intervention focused on stress management. The study also aims to assess the durability of treatment effects over six months and conduct a health economic evaluation. A process evaluation will further explore the implementation and impact mechanisms of the I-ERP intervention.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 7 to 17 with a diagnosis of both autism and OCD.

Not a fit: Patients without a confirmed diagnosis of OCD or autism, or those outside the age range, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide accessible and effective treatment options for children with OCD and autism, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using internet-delivered cognitive-behavioral therapies for various conditions, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. A DSM-5 diagnosis of OCD. Confirmed by the assessor at the inclusion assessment, based on a structured diagnostic interview.
3. A total score of ≥16 on the CY-BOCS. Confirmed by the assessor at the inclusion assessment.
4. Age between 7 and 17 years. Confirmed by the caregiver and subsequently by the medical record system.
5. Ability to read and write Swedish. Confirmed by the caregiver at the telephone screening or/and the inclusion assessment.
6. Regular access to a computer or a smartphone/tablet connected to the internet, and a mobile phone to receive text messages. Confirmed by the caregiver at the telephone screening or/and inclusion assessment.
7. A parent/caregiver able to participate in the treatment alongside their child. Confirmed by the caregiver at the telephone screening or/and the inclusion assessment.

Exclusion Criteria:

1. 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).
2. Comorbid psychotic disorder, bipolar disorder, severe eating disorder, severe depression, alcohol/substance dependence or hoarding disorder. Confirmed by the caregiver at the telephone screening and subsequently by the assessor at the inclusion assessment based on the structured diagnostic interview and, if required, the medical record.
3. Current suicidal intent or a previous suicide attempt within the last 12 months. Confirmed by the assessor at the inclusion assessment and, if required, the medical record.
4. Main symptom presentation consists of hoarding symptoms. Confirmed by the assessor at the inclusion assessment.
5. Completed CBT for OCD within the last 12 months prior to the inclusion assessment (defined as at least 5 sessions of CBT including ERP). Confirmed by the caregiver at the telephone screening or/and inclusion assessment and, if required, the medical record.
6. Simultaneous psychological treatment for OCD or anxiety. Confirmed by the caregiver at the telephone screening and/or inclusion assessment.
7. Initiation, dosage change or cessation of medication for OCD (primarily selective serotonin reuptake inhibitors, SSRIs) or behavioural symptoms of ASD (atypical antipsychotics) within the 6 weeks prior to the baseline assessment. Confirmed by the caregiver at the telephone screening and the inclusion assessment and, if required, the medical record.
8. Having a close relationship to an already included participant (e.g., sibling, cousin), to avoid being randomised into two different arms, with the risk of information "leaking" between the groups. Confirmed by the caregiver or assessor at the telephone screening and/or at the inclusion assessment.

Where this trial is running

Lund, Skåne County and 2 other locations

• Forskningsmottagning barn- och ungdomspsykiatri Lund — Lund, Skåne County, Sweden (Recruiting)
• Child and Adolescent Psychiatry Research Center — Stockholm, Stockholm County, Sweden (Recruiting)
• BUP Specialmottagning — Gothenburg, Västra Götalandsregionen, Sweden (Recruiting)

Study contacts

• Principal investigator: David Mataix-Cols — Karolinska Institutet
• Study coordinator: David Mataix-Cols

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