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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Internet-delivered exposure and response prevention (I-ERP)
BehavioralThe 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 stress management (I-SM)
BehavioralThe 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Internet-delivered exposure and response prevention (I-ERP)Experimental treatment 1 intervention
Group B: Internet-delivered stress management (I-SM)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.Secondary outcomes
1
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of the OCD severity. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Time frame
Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.2
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Time frame
Post treatment (week 12), 3-months follow-up, 6-months follow up.3
Treatment response and remission
Treatment response will be defined as at least 35% reduction on the CY-BOCS and a CGI-I score of 1 (very much improved) or 2 (much improved). Remission will be defined as a score of less than or equal to 12 on the CY-BOCS and a CGI-S rating of 1 (normal, not at all ill) or 2 (borderline mentally ill).
Time frame
Post treatment (week 12), 3-months follow-up, 6-months follow up.4
Children's Global Assessment Scale (CGAS)
The CGAS is a single item 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher scores mean better outcome. It will be used in this trial to provide an assessor-rated opinion of global improvement (not restricted to OCD symptoms).
Time frame
Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.Other outcomes
1
Demographic data - clinician-entered
Following the inclusion assessment, the assessor enters baseline information into the trial database. This includes information on e.g., age, primary responsible caregiver assisting during the treatment, general cognitive ability, comorbid diagnoses, distance to the clinic in kilometres, age of OCD onset, history of suicide attempt, family history of OCD and ASD, family history of other psychiatric disorders, current medication for ASD, OCD or other psychiatric disorder, and previous psychological treatment for OCD or other psychiatric disorders.
Time frame
Baseline (week 0).2
Demographic data - parent-reported
At baseline, the parent/caregiver will answer a questionnaire designed by the research team asking about e.g., the caregiver's relation to the child, who the child lives with, the child's sex and gender, number of siblings, the caregivers' educational level, the caregivers' occupation, the country in which the child and caregivers were born, how the caregiver learned about the trial, and if the child has been in previous contact with health care services due to her/his OCD or other psychiatric symptoms.
Time frame
Baseline (week 0).3
Comorbid psychiatric disorders
Psychiatric diagnoses at baseline, including OCD, will be based on DSM-5 diagnostic criteria and assessed with the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders-Child and Adolescent Version (DIAMOND-KID).
Time frame
Baseline (week 0).4
Social Communication Questionnaire (SCQ)
The SCQ is a parent-rated measure of autistic symptoms that includes 40 items, yielding a total score of 0-40.
Time frame
Baseline (week 0).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Region Skane
Collaborator
Vastra Gotaland Region
Collaborator
Source ClinicalTrials.gov