Obsessive Compulsive BehaviorDOT-YNCT07864675
Digital OC Training in Children and Adolescents
A study testing Digital behavioral training in people with Obsessive Compulsive Behavior, run by Aarhus University Hospital.
Trial summary
The project is an interventional trial that compares digital training programs with varying levels of therapeutic contact. All participating children and adolescents will receive a digital training program following a thorough online evaluation. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obsessive Compulsive Behavior
- What is being tested?
- Digital behavioral training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Nov 2030
- 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
- Exclusion Criteria: Severe obsessive-compulsive symptoms (often requiring more intensive treatment and frequently referred to the hospital), suicidal thoughts or severe depression, severe anorexia, psychosis, clinical impression of intellectual disability, insufficient language skills.
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evidence-Based Early Intervention for Children and Adolescents With Obsessive-Compulsive Symptoms - a Digital Treatment Program for Children and Adolescents, Supplemented by a Supportive Parent Program A Feasibility and Acceptability Study
The project is an interventional trial that compares digital training programs with varying levels of therapeutic contact. All participating children and adolescents will receive a digital training program following a thorough online evaluation. Additionally, parents are invited to participate in an online, supportive parenting program designed to complement the digital treatment.
Read the detailed description
The training program was developed through a co-creation process involving children and adolescents with lived experience of OCD and who had previously completed a cognitive behavioural therapy (CBT) training program, as well as parents of children who had previously received therapeutic treatment for OCD.
The aim of the present clinical research project is to evaluate the feasibility and acceptability of the newly developed interactive digital training program for obsessive compulsive symptoms in children and adolescents, including two groups: limited versus regular digital therapist guidance in a randomized trial. The project expands evidence-based online assessment, which gives the possibility of developing a systematic target group definition, and conducting a systematic effectiveness evaluation of the digital training.
Specific objectives:
To examine feasibility and acceptability of the training program To evaluate the experienced effects of the training program in terms of the experienced symptom severity of obsessions and compulsions To evaluate the changes in children's and adolescent's well-being and distress over time To explore how the parents experience the supportive parent program
Statistical procedures:
Single-case case analysis:
The design is a Multiple Baseline Design across individuals with a baseline evaluation (at primary evaluation), and another baseline evaluation before module 1 (within 1 to 3 weeks after primary evaluation), biweekly evaluations during training and evaluation after treatment.
Visual analyses are used to determine whether there is a functional relation between the intervention and the outcome. If evidence for a functional effect, the visual analysis is supplemented with quantitative analysis methods evaluating the magnitude of the intervention effect. Effect sizes are combined across cases to estimate overall average intervention effects which contributes to evidence-based practice, theory, and future applications (doi: 10.1097/NPT.0000000000000187)
Efficacy analysis:
The analyses are performed in according to the intention-to-treat principle using a linear mixed-effect model with random effects for repeated measures with maximum likelihood estimation with the assumption that data were missing at random. The model includes fixed effects for group and time, as well as individuals' random intercept and random slope. The interaction effect of group-by-time will be used to evaluate group differences after treatment (at 9 weeks)
Qualitative interviews (semistructurered interviews) conducted prior to treatment will focus on children/adolescents' and parents' experiences of obsessive-compulsive symptoms, including perceived burden in daily life and perceived treatment needs. Post-treatment interviews will focus on perceived usability, usefulness, and satisfaction with the digital intervention, symptom change, adherence to the program, as well as perceived need for parental involvement and support. The interviews are analysed using the Reflexive Thematic Analysis which is a six-phase method that supports both the practical development of codes and a structured analytic process, thereby focusing on the interpretation and understanding of the underlying meanings within the data
- Conditions
- Obsessive Compulsive Behavior
- Being tested
- Digital behavioral training
- Keywords
- obsession, compulsion, adolescent, children, digital
- Medical subject headings
- Compulsive Behavior, Obsessive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital behavioral trainingBehavioural
The program is structured into distinct sessions, through which children and adolescents are educated about obsessions and compulsions and provided with strategies for managing their symptoms. The primary objective is to equip participants with effective coping techniques. In parallel, parents are offered a supplementary treatment program designed to provide support in their involvement in the therapeutic process.
Both programs are online using videos, interactive materials and assignments for both the children/youth and the parents.
Both intervention arms involve the same program. The only difference is the extent of therapist contact
| Study group | Role | What they receive |
|---|---|---|
| Therapeut-assisted arm | Active comparator | Participants are required to chat with the therapist during sessions 2 and 6 and have the option to chat with the therapist during all other weeks. Receives: Behavioral: Digital behavioral training |
| Limited therapeut-assisted arm | Active comparator | Participants are required to chat with the therapist during sessions 2 and 6. They are not allowed to chat with the therapist during the other weeks Receives: Behavioral: Digital behavioral training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability
Participant retention: the number of included participants fulfilling the training program and evaluation at end of treatment, higher scores mean better
Measured: 9 weeks
Adverse effects
Swedish short questionnaire (description) about adverse effects, 0-1, Higher scores are worse
Measured: Session 2 (2 weeks), session 6 (6 weeks), 9 weeks
Experienced impairment from OC symptoms, experienced change after the training program
Qualitative interviews
Measured: baseline, 9 weeks
Single-case study
Obsessive Compulsive Inventory (OCI/chOCI-RP), 0-2, Higher scores mean worse
Measured: baseline, every second week (week 2, 4, 6, 8), 9 weeks
Feasibility and acceptability
Study take-up: calculating the average number of included participants per week
Measured: baseline
Feasibility and acceptability
How much the participant engage in the program (youth and parents): Number of training sessions per week, higher scores mean better
Measured: 9 weeks
Feasibility and acceptability
Post-treatment satisfaction assessed using items from the Client Satisfaction Questionnaire (CSQ): 0-4, higher scores mean better
Measured: 9 weeks
Secondary outcomes (2)
To evaluate whether the digital training program can change the intensity of the obsessions and compulsions
Children Yale brown Obsessive Compulsive Scale (CYBOCS), 0-4, higher scores mean worse
Measured: baseline, 9 weeks, 3 months
To evaluate whether the digital training program can change the intensity of the obsessions and compulsions
Obsessive Compulsive Inventory (OCI/chOCI-RP), 0-2, Higher scores mean worse
Measured: Baseline, 9 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive BehaviorStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of IT and Digitalization, AUH, Participating municipalities in Central Region Denmark
- Responsible party
- Principal investigator, Judith Becker Nissen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864675
- Sponsor's protocol ID
- 1-16-02-343-25
- Acronym
- DOT-Y
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not in accordance with the approval from the ethical committee
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Early Intervention for Children and Adolescents With Obsessive-Compulsive Symptoms - a Digital Treatment Program for Children and Adolescents, Supplemented by a Supportive Parent Program A Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT07864675
- Acronym / sponsor ID
- DOT-Y / 1-16-02-343-25
- Conditions
- Obsessive Compulsive Behavior
- Keywords
- obsession, compulsion, adolescent, children, digital
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Department of IT and Digitalization, AUH, Participating municipalities in Central Region Denmark
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 8 Oct 2026 (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 project is an interventional trial that compares digital training programs with varying levels of therapeutic contact. All participating children and adolescents will receive a digital training program following a thorough online evaluation. Additionally, parents are invited to participate in an online, supportive parenting program designed to complement the digital treatment.
Detailed description
The training program was developed through a co-creation process involving children and adolescents with lived experience of OCD and who had previously completed a cognitive behavioural therapy (CBT) training program, as well as parents of children who had previously received therapeutic treatment for OCD.
The aim of the present clinical research project is to evaluate the feasibility and acceptability of the newly developed interactive digital training program for obsessive compulsive symptoms in children and adolescents, including two groups: limited versus regular digital therapist guidance in a randomized trial. The project expands evidence-based online assessment, which gives the possibility of developing a systematic target group definition, and conducting a systematic effectiveness evaluation of the digital training.
Specific objectives:
To examine feasibility and acceptability of the training program To evaluate the experienced effects of the training program in terms of the experienced symptom severity of obsessions and compulsions To evaluate the changes in children's and adolescent's well-being and distress over time To explore how the parents experience the supportive parent program
Statistical procedures:
Single-case case analysis:
The design is a Multiple Baseline Design across individuals with a baseline evaluation (at primary evaluation), and another baseline evaluation before module 1 (within 1 to 3 weeks after primary evaluation), biweekly evaluations during training and evaluation after treatment.
Visual analyses are used to determine whether there is a functional relation between the intervention and the outcome. If evidence for a functional effect, the visual analysis is supplemented with quantitative analysis methods evaluating the magnitude of the intervention effect. Effect sizes are combined across cases to estimate overall average intervention effects which contributes to evidence-based practice, theory, and future applications (doi: 10.1097/NPT.0000000000000187)
Efficacy analysis:
The analyses are performed in according to the intention-to-treat principle using a linear mixed-effect model with random effects for repeated measures with maximum likelihood estimation with the assumption that data were missing at random. The model includes fixed effects for group and time, as well as individuals' random intercept and random slope. The interaction effect of group-by-time will be used to evaluate group differences after treatment (at 9 weeks)
Qualitative interviews (semistructurered interviews) conducted prior to treatment will focus on children/adolescents' and parents' experiences of obsessive-compulsive symptoms, including perceived burden in daily life and perceived treatment needs. Post-treatment interviews will focus on perceived usability, usefulness, and satisfaction with the digital intervention, symptom change, adherence to the program, as well as perceived need for parental involvement and support. The interviews are analysed using the Reflexive Thematic Analysis which is a six-phase method that supports both the practical development of codes and a structured analytic process, thereby focusing on the interpretation and understanding of the underlying meanings within the data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeut-assisted arm | Active comparator | Behavioral: Digital behavioral trainingParticipants are required to chat with the therapist during sessions 2 and 6 and have the option to chat with the therapist during all other weeks. |
| Limited therapeut-assisted arm | Active comparator | Behavioral: Digital behavioral trainingParticipants are required to chat with the therapist during sessions 2 and 6. They are not allowed to chat with the therapist during the other weeks |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Exclusion Criteria: Severe obsessive-compulsive symptoms (often requiring more intensive treatment and frequently referred to the hospital), suicidal thoughts or severe depression, severe anorexia, psychosis, clinical impression of intellectual disability, insufficient language skills.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Digital behavioral trainingThe program is structured into distinct sessions, through which children and adolescents are educated about obsessions and compulsions and provided with strategies for managing their symptoms. The primary objective is to equip participants with effective coping techniques. In parallel, parents are offered a supplementary treatment program designed to provide support in their involvement in the therapeutic process. Both programs are online using videos, interactive materials and assignments for both the children/youth and the parents. Both intervention arms involve the same program. The only difference is the extent of therapist contact | Behavioural | Limited therapeut-assisted arm, Therapeut-assisted arm |
Primary outcome
Feasibility and acceptability
Time frame: 9 weeks
Participant retention: the number of included participants fulfilling the training program and evaluation at end of treatment, higher scores mean better
Adverse effects
Time frame: Session 2 (2 weeks), session 6 (6 weeks), 9 weeks
Swedish short questionnaire (description) about adverse effects, 0-1, Higher scores are worse
Experienced impairment from OC symptoms, experienced change after the training program
Time frame: baseline, 9 weeks
Qualitative interviews
Single-case study
Time frame: baseline, every second week (week 2, 4, 6, 8), 9 weeks
Obsessive Compulsive Inventory (OCI/chOCI-RP), 0-2, Higher scores mean worse
Feasibility and acceptability
Time frame: baseline
Study take-up: calculating the average number of included participants per week
Feasibility and acceptability
Time frame: 9 weeks
How much the participant engage in the program (youth and parents): Number of training sessions per week, higher scores mean better
Feasibility and acceptability
Time frame: 9 weeks
Post-treatment satisfaction assessed using items from the Client Satisfaction Questionnaire (CSQ): 0-4, higher scores mean better
2 secondary outcomes
To evaluate whether the digital training program can change the intensity of the obsessions and compulsions
Time frame: baseline, 9 weeks, 3 months
To evaluate whether the digital training program can change the intensity of the obsessions and compulsions
Time frame: Baseline, 9 weeks, 3 months
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 8 Oct 2026.
- Individual participant dataSharing planned: No. It is not in accordance with the approval from the ethical committee
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital behavioral training in people with Obsessive Compulsive Behavior, run by Aarhus University Hospital.
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 2 inclusion and 0 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Judith Becker Nissen, PhD, associate professor (21622339 ext. 0045, judiniss@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability (time frame: 9 weeks). The study lists 7 primary outcomes in all. 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 8 Oct 2026.