Obsessive-Compulsive DisorderNCT06582225
ICBT for OCD in Children With Autism
A study testing Internet-delivered exposure and response prevention (I-ERP) and Internet-delivered stress management (I-SM) in people with Obsessive-Compulsive Disorder and Autism Spectrum Disorder, run by Karolinska Institutet at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Autism Spectrum Disorder
- What is being tested?
- Internet-delivered exposure and response prevention (I-ERP) and Internet-delivered stress management (I-SM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesSweden
- Study dates
- 25 Nov 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
BUP Specialmottagning
Gothenburg, Västra Götalandsregionen, 411 14
Karin Melin, PhD, +4673-049 43 48, karin.a.melin@vgregion.se
Lisa Norlin, MSc, lisa.norlin@vgregion.se
- Recruiting
Forskningsmottagning barn- och ungdomspsykiatri Lund
Lund, Skåne County, 222 41
Per Andrén, PhD, +4670-435 17 40, per.andren@med.lu.se
Hilma Carlsson, MSc, hilma.carlsson@skane.se
- Recruiting
Child and Adolescent Psychiatry Research Center
Stockholm, 113 30
David Mataix-Cols, Professor, +46 723986889, david.mataix.cols@ki.se
Moa Warnström, MSc, +46 812352591, moa.warnstrom@ki.se
About this study
Official title: Internet-delivered Cognitive-behaviour Therapy for Obsessive- Compulsive Disorder in Children With Autism: A Randomised Controlled 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.
Read the detailed description
Primary objective: To determine the clinical efficacy of autism-adapted internet-delivered exposure with response prevention (I-ERP) in reducing OCD symptom severity (as measured by the Children's Yale Brown-Obsessive Compulsive Scale; CY-BOCS) in children and adolescents with OCD and autism spectrum disorder (ASD), compared with an active control intervention of high ecological validity (internet-delivered stress management; I-SM).
Secondary objectives:
- To establish the 6-month durability of the treatment effects in a naturalistic follow-up.
- To conduct a health economic evaluation of I-ERP, compared with I-SM, at the primary endpoint (3-month follow-up) from the health organisation payer, health care sector, and societal perspectives.
- To conduct a process evaluation with a subset of participants allocated to the I-ERP arm, focusing on implementation, mechanisms of impact, and context.
Type of trial: A multisite parallel-group randomised controlled superiority trial, with embedded health economic and process evaluation.
Rationale: OCD and ASD are two frequently co-occuring disorders, associated with significant impairments in daily life. Cognitive-behavioural therapy (CBT) specifically adapted to ASD is a promising treatment for this patient group, but further research is needed to fully establish its efficacy. Furthermore, ASD-adapted CBT for OCD is a highly specialised treatment, not accessible for most patients. Offering treatment in a digital format could dramatically increase treatment availability for these children.
Planned trial sites: The study will be coordinated from the Department of Clinical Neuroscience at Karolinska Institutet (the Sponsor). There will be three collaborating study sites: BUP OCD och relaterade tillstånd (Region Stockholm), BUP Specialmottagning (Västra Götalandsregionen), and BUP Skåne (Region Skåne). Each of the three sites will assess and treat participants from their own region, and occasionally from adjacent regions.
Trial design and methods: All potential participants are initially screened via the telephone or at one of the three participating centres. If screening is positive, an inclusion assessment will follow. Individuals who are eligible and have consented to participate in the trial will be randomised to one of two trial arms. In one arm, participants will receive 12 modules of therapist- and parent-guided I-ERP for OCD adapted for autism. In the active comparator arm, participants will receive 12 modules of therapist- and parent-guided I-SM. Participants in the comparator group will be offered to cross-over to the I-ERP intervention after the primary endpoint.
Participants will complete outcome measures at baseline (week 0), post-treatment (week 12), and 3- and 6-months post-treatment. The primary outcome variable is the clinician-reported Children's Yale Brown-Obsessive Compulsive Scale (CY-BOCS), and the primary endpoint is the 3-month follow-up after treatment.
Secondary outcomes include measures of self-reported OCD symptoms, family accommodation, functional impairment, and depressive symptoms. Health-related quality of life and resource use will be collected for the health economic evaluation. Follow-up assessments will be conducted at the clinic or via videoconferencing, in both cases complemented with online questionnaires.
A subset of participants will participate in a process evaluation of the I-ERP intervention.
Sample: A total of 220 autistic children and adolescents diagnosed with OCD and their primary caregivers.
Statistical methodology and analysis: Data will be analysed using a pre-specified intention-to-treat statistical analysis plan. The primary outcome will be analysed using a linear mixed effects model. Secondary outcomes will be analysed using analogous methods. A health economic evaluation of the intervention from the health organisation payer, health care sector, and societal perspectives will also be conducted, as well as a process evaluation including both quantitative and qualitative measures.
- Being tested
- Internet-delivered exposure and response prevention (I-ERP), Internet-delivered stress management (I-SM)
- Keywords
- Obsessive-Compulsive Disorder, Autism Spectrum Disorder, Exposure and Response Prevention, Cognitive-Behavioural Treatment, Internet, Guided self-help, Stress Management
- Medical subject headings
- Obsessive-Compulsive Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered exposure and response prevention (I-ERP)Behavioural
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 stress management (I-SM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Internet-delivered stress management (I-SM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Secondary outcomes (19)
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.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Measured: Post treatment (week 12), 3-months follow-up, 6-months follow up.
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).
Measured: Post treatment (week 12), 3-months follow-up, 6-months follow up.
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).
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Obsessive-Compulsive Inventory - Child version - revised (OCI-CV-R)
The OCI-CV-R is an 18-item self-reported measure of OCD symptoms. Each item is scored on a 3-point scale (0=never, 1=sometimes, 2=always). The OCI-CV-R generates a total score ranging from 0-36 points and five sub-scores (doubting/checking, obsessing, washing, ordering, and neutralizing), with higher scores indicating greater OCD symptom severity.
Measured: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Children's Obsessive-Compulsive Inventory-Revised-Parent version (ChOCI-R-P)
The ChOCI-R-P is a parent-rated measure of OCD symptom severity that includes a checklist and a severity rating with 12 items, yielding a total score of 0-48 with higher scores indicating greater OCD symptom severity.
Measured: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Generalized Anxiety Disorder - 7 item scale (GAD-7)
The GAD-7 is a measure of anxiety rated by the child/adolescent. It consists of 7 items and each item is rated from 0=not at all to 3=almost every day, yielding a total score of 0-21. Lower scores mean better outcome.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Child Health Utility 9D (CHU9D)
The CHU9D is a 9-item measure of quality of life rated by the child/adolescent. Each item is scored from 1 to 5, assessing children's functioning "today" across domains of worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine and activities. Scores are converted to utility weights using a scoring algorithm. Weights range between 0 (denoting the health state "dead") and 1 (denoting the health state "perfect health"). Weights are then used to estimate quality adjusted life years (QALY) to be used in the health economic evaluation.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
The TiC-P will be used to assess healthcare and societal resource use for the health economic evaluation. The questionnaire includes items on healthcare resource use (e.g., healthcare visits), supportive resources (e.g., private tutoring), medications, prescription-free drugs, school absenteeism, academic productivity loss, and parental productivity loss and is frequently used in health economic studies. The TiC-P version used in the study has been adapted by the research team for the use among young people and parents and used in previous trials. No scores as such are available for this measure. Parent rated.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS)
The PEAS/PRAS is a self-rated 3-item measure of patient adherence to exposure with response prevention (PEAS) with 3 items rated from 0 to 6, yielding a total score of 0-18, where higher scores indicate greater adherence. For the current trial, the measure will be administered as a self- rated version in the I-ERP group. A corresponding version (PRAS) has been developed by the research team and will be administered to participants in the control group to assess adherence to I-SM intervention.
The PEAS/PRAS is a 3-item measure of patient adherence to exposure and response prevention (PEAS) or relaxation training (PRAS). The PEAS/PRAS is one single measure but it is adapted to each of the two arms. The PEAS/PRAS has 3 items rated from 0 to 6, yielding a total score of 0-18. Higher scores mean better outcome. For the current trial, the PEAS will be administered as a self-rated version in the I-ERP group and the PRAS will be administered as a self-rated version in the I-SM group.
Measured: During treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up.
Treatment preference
Two items will be administered to both the participant and the parent to assess treatment format preference (i.e., if the participant/parent would have preferred to receive internet-delivered treatment or in-person treatment for his/her symptoms or if it does not matter), as well as how important the participant and parent believe it is to be able to choose which treatment format they receive (rated on a 5-point scale). The questionnaire has been developed by the research team.
Measured: Baseline (week 0), post treatment (week 12).
Treatment Credibility and Expectancy Scale (TCES)
The TCES will be administered to both the participant and the parent to assess the treatment credibility and expectancy of treatment outcome. The TCES includes 5 items rated from 0 to 10, yielding a total score of 0-40, where higher scores indicate higher credibility.
Measured: During treatment (week 3).
Working alliance inventory (WAI)
The WAI is a measure of perceived working alliance with the therapist that includes 6 items rated from 1=never to 7=always, yielding a total score of 7-49. It will be administered to both the participant and the parent. Higher scores mean better working alliance.
Measured: During treatment (week 3).
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is an 8-item measure of treatment satisfaction. Each item is rated from 1 to 4, yielding a total score of 9-36. Higher scores mean more satisfaction. It will be administered to both the participant and the parent.
Measured: Post treatment (week 12), 3-months follow-up.
Family Accommodation Scale - self-rated (FAS-SR)
The FAS-SR is a measure of family accommodation that includes 19 items about family accommodation. For the purpose of this trial, the checklist with obsessions and compulsions has been excluded, since it is not included in the total severity score and overlaps with the checklist in the ChOCI-R-P. Each item is rated from 0=none/never to 4=every day, yielding a total score of 0-76. Higher scores are associated with greater levels of family accommodation.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Work and Social Adjustment Scale - youth (WSAS-Y)
The WSAS-Y is a 5-item measure of functional impairment rated by the child/adolescent. Each item is rated from 0=not at all to 8=severely impaired, yielding a total score of 0-40. Lower scores mean better outcome.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Work and Social Adjustment Scale - parent version (WSAS-P)
The WSAS-P is a 5-item measure of functional impairment rated by the parent. Each item is rated from 0=not at all to 8=severely impaired, yielding a total score of 0-40. Lower scores mean better outcome.
Measured: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Short Mood and Feeling Questionnaire - child (SMFQ-C) + additional suicide item
The SMFQ-C is a measure of depressive symptoms rated by the child/adolescent. It consists of 13 items and each item is scored on a 3-point scale (0=not true, 1=sometimes, 2=true). The total score is derived by adding up the values for each 13 items, yielding a total score of 0-26 points. Lower scores mean better outcome. For this trial, an item has been added aimed to assess suicide risk.
Measured: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Short Mood and Feeling Questionnaire - parent version (SMFQ-P)
The SMFQ-P is a measure of depressive symptoms rated by the parent. It consists of 13 items and each item is scored on a 3-point scale (0=not true, 1=sometimes, 2=true). The total score is derived by adding up the values for each 13 items, yielding a total score of 0-26 points. Lower scores mean better outcome.
Measured: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start25 Nov 2024
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multisite parallel-group randomised controlled superiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Vastra Gotaland Region
- Responsible party
- Principal investigator, David Mataix-Cols, Karolinska Institutet
- Investigators
- David Mataix-Cols, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582225
- Sponsor's protocol ID
- 2023-01968-01
- Other IDs
- 2023
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive-behaviour Therapy for Obsessive- Compulsive Disorder in Children With Autism: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06582225
- Acronym / sponsor ID
- 2023-01968-01
- Keywords
- Obsessive-Compulsive Disorder, Autism Spectrum Disorder, Exposure and Response Prevention, Cognitive-Behavioural Treatment, Internet, Guided self-help, Stress Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Vastra Gotaland Region
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objective: To determine the clinical efficacy of autism-adapted internet-delivered exposure with response prevention (I-ERP) in reducing OCD symptom severity (as measured by the Children's Yale Brown-Obsessive Compulsive Scale; CY-BOCS) in children and adolescents with OCD and autism spectrum disorder (ASD), compared with an active control intervention of high ecological validity (internet-delivered stress management; I-SM).
Secondary objectives:
- To establish the 6-month durability of the treatment effects in a naturalistic follow-up.
- To conduct a health economic evaluation of I-ERP, compared with I-SM, at the primary endpoint (3-month follow-up) from the health organisation payer, health care sector, and societal perspectives.
- To conduct a process evaluation with a subset of participants allocated to the I-ERP arm, focusing on implementation, mechanisms of impact, and context.
Type of trial: A multisite parallel-group randomised controlled superiority trial, with embedded health economic and process evaluation.
Rationale: OCD and ASD are two frequently co-occuring disorders, associated with significant impairments in daily life. Cognitive-behavioural therapy (CBT) specifically adapted to ASD is a promising treatment for this patient group, but further research is needed to fully establish its efficacy. Furthermore, ASD-adapted CBT for OCD is a highly specialised treatment, not accessible for most patients. Offering treatment in a digital format could dramatically increase treatment availability for these children.
Planned trial sites: The study will be coordinated from the Department of Clinical Neuroscience at Karolinska Institutet (the Sponsor). There will be three collaborating study sites: BUP OCD och relaterade tillstånd (Region Stockholm), BUP Specialmottagning (Västra Götalandsregionen), and BUP Skåne (Region Skåne). Each of the three sites will assess and treat participants from their own region, and occasionally from adjacent regions.
Trial design and methods: All potential participants are initially screened via the telephone or at one of the three participating centres. If screening is positive, an inclusion assessment will follow. Individuals who are eligible and have consented to participate in the trial will be randomised to one of two trial arms. In one arm, participants will receive 12 modules of therapist- and parent-guided I-ERP for OCD adapted for autism. In the active comparator arm, participants will receive 12 modules of therapist- and parent-guided I-SM. Participants in the comparator group will be offered to cross-over to the I-ERP intervention after the primary endpoint.
Participants will complete outcome measures at baseline (week 0), post-treatment (week 12), and 3- and 6-months post-treatment. The primary outcome variable is the clinician-reported Children's Yale Brown-Obsessive Compulsive Scale (CY-BOCS), and the primary endpoint is the 3-month follow-up after treatment.
Secondary outcomes include measures of self-reported OCD symptoms, family accommodation, functional impairment, and depressive symptoms. Health-related quality of life and resource use will be collected for the health economic evaluation. Follow-up assessments will be conducted at the clinic or via videoconferencing, in both cases complemented with online questionnaires.
A subset of participants will participate in a process evaluation of the I-ERP intervention.
Sample: A total of 220 autistic children and adolescents diagnosed with OCD and their primary caregivers.
Statistical methodology and analysis: Data will be analysed using a pre-specified intention-to-treat statistical analysis plan. The primary outcome will be analysed using a linear mixed effects model. Secondary outcomes will be analysed using analogous methods. A health economic evaluation of the intervention from the health organisation payer, health care sector, and societal perspectives will also be conducted, as well as a process evaluation including both quantitative and qualitative measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multisite parallel-group randomised controlled superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered exposure and response prevention (I-ERP) | Experimental | Behavioral: Internet-delivered exposure and response prevention (I-ERP)A therapist-guided, internet-delivered exposure and response prevention (I-ERP) programme for children and adolescents with OCD and autism. |
| Internet-delivered stress management (I-SM) | Active comparator | Behavioral: Internet-delivered stress management (I-SM)A therapist-guided, internet-delivered stress management (I-SM) programme for children and adolescents with OCD and autism. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- Ability to read and write Swedish. Confirmed by the caregiver at the telephone screening or/and the inclusion assessment.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered exposure and response prevention (I-ERP)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. | Behavioural | Internet-delivered exposure and response prevention (I-ERP) |
| Internet-delivered stress management (I-SM)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. | Behavioural | Internet-delivered stress management (I-SM) |
Primary outcome
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
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.
19 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Clinical Global Impression - Improvement (CGI-I)
Time frame: Post treatment (week 12), 3-months follow-up, 6-months follow up.
Treatment response and remission
Time frame: Post treatment (week 12), 3-months follow-up, 6-months follow up.
Children's Global Assessment Scale (CGAS)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Obsessive-Compulsive Inventory - Child version - revised (OCI-CV-R)
Time frame: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Children's Obsessive-Compulsive Inventory-Revised-Parent version (ChOCI-R-P)
Time frame: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Generalized Anxiety Disorder - 7 item scale (GAD-7)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Child Health Utility 9D (CHU9D)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS)
Time frame: During treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up.
Treatment preference
Time frame: Baseline (week 0), post treatment (week 12).
Treatment Credibility and Expectancy Scale (TCES)
Time frame: During treatment (week 3).
Working alliance inventory (WAI)
Time frame: During treatment (week 3).
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post treatment (week 12), 3-months follow-up.
Family Accommodation Scale - self-rated (FAS-SR)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Work and Social Adjustment Scale - youth (WSAS-Y)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Work and Social Adjustment Scale - parent version (WSAS-P)
Time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.
Short Mood and Feeling Questionnaire - child (SMFQ-C) + additional suicide item
Time frame: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Short Mood and Feeling Questionnaire - parent version (SMFQ-P)
Time frame: Baseline (week 0), during treatment (week 3, week 6, week 9), post treatment (week 12), 3-months follow-up, 6-months follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Mataix-Cols principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered exposure and response prevention (I-ERP) and Internet-delivered stress management (I-SM) in people with Obsessive-Compulsive Disorder and Autism Spectrum Disorder, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Mataix-Cols (+46723986889, david.mataix.cols@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (time frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.