ICBT for OCD in Children With Autism (NCT06582225) | Clinical Trial Compass
RecruitingNot Applicable
ICBT for OCD in Children With Autism
Sweden220 participantsStarted 2024-11-25
Plain-language 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.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Ability to read and write Swedish. Confirmed by the caregiver at the telephone screening or/and the inclusion assessment.
. 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.
. 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
. 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.
. 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.
. Simultaneous psychological treatment for OCD or anxiety. Confirmed by the caregiver at the telephone screening and/or inclusion assessment.
. 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.
. 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.