ICBT for OCD in Children With Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
Qualifiers
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).
A DSM-5 diagnosis of OCD. Confirmed by the assessor at the inclusion assessment, based on a structured diagnostic interview.
A total score of ≥16 on the CY-BOCS. Confirmed by the assessor at the inclusion assessment.
Age between 7 and 17 years. Confirmed by the caregiver and subsequently by the medical record system.
Disqualifiers
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).
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.
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.
Main symptom presentation consists of hoarding symptoms. Confirmed by the assessor at the inclusion assessment.
Trial design
Treatments tested in this trial
- Internet-delivered exposure and response prevention (I-ERP)
- Internet-delivered stress management (I-SM)
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Region Skane
Collaborator
Vastra Gotaland Region
Collaborator
Source ClinicalTrials.gov