Child Behavior ProblemNCT06559813
Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems
A study testing Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality in people with Child Behavior Problem and Disruptive Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The main aim of this pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Child Behavior Problem, Disruptive Behavior, Oppositional Defiant Disorder
- What is being tested?
- Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 27 Aug 2024to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents:
- Parent of a child aged 8-16 years
- The parent perceives that the child has oppositional, angry or aggressive behaviors, and/or that there are parent-child conflicts at home.
- The child's behavior is elevated on a measure targeting behavioral problems (SDQ conduct problems subscale)
Who cannot join
- Parent treatment:
- Parent of a child under 8 years or over 16 years of age
- The child does not currently exhibit oppositional, angry or aggressive behaviors
- Child diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors
- Parent has epilepsy or migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Parents of Children With Anger, Oppositional or Aggressive Behaviors
The main aim of this pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). The parent training program is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR).
The main questions the project aims to answer are:
Read more
- What are the preliminary effects of the CBT-VR parent training program?
- What is the level of parent engagement in the CBT-VR parent training program?
- What are the experiences of parents and therapists of the CBT-VR parent training program?
The CBT-VR parenting program is delivered at clinics during individual sessions. Parents will answer quantitative measurements before, during, and after treatment. Within-group analyses will be conducted to examine experiences and preliminary effects of the program. Parents and clinicians are also asked to participate in a qualitative interview after the program has ended.
Read the detailed description
BACKGROUND:
Parent training programs based on cognitive behavioral therapy (CBT) have shown positive effects for reducing child behavior problems, such as oppositional defiant and aggressive behaviors, and are often recommended as a first intervention. The focus of CBT-based parenting programs are e.g. to reduce negative parent-child interactions and increase positive communication.
Recently, studies have evaluated CBT with the addition of exercises and role-playing in virtual reality (VR), for instance for adults with anxiety or anger. VR can provide a safe and gradual platform to practice in environments and situations. The present project evaluates a CBT-based parenting program, which includes practicing of skills in VR.
PURPOSE AND RESEARCH QUESTIONS:
The aim of this project is to evaluate preliminary effects and feasibility of a CBT-VR parent training program. The specific research questions are as follows:
- What are the preliminary effect of the CBT-VR parent training program on children's behavioral problems, well-being, parents' emotion regulation, parenting strategies, and family conflicts?
- What is the level of parent engagement in the CBT-VR parent training program (e.g., the number of sessions, exercises, homework completion and dropout rates)?
- What are the experiences of parents and therapists of the CBT-VR parent training program (e.g., its effectiveness, acceptability, usefulness as well as relevance of the strategies taught)?
METHODS:
This project consists of a small pilot study of a CBT-VR parent training program for parents with children aged 8-16 years (n=10 families). The design is based on a mixed-methods approach. Evaluation of the intervention is conducted using within-group design (repeated measurements before, during, and after the intervention).
Parents will be recruited through clinics and advertisements. They are directed to a webpage with information about the study and contact information to the researchers. Parents give written informed consent to participate. When parents are interested in participating, a member of the research team will contact the participant for screening of inclusion and exclusion criteria. Clinicians at the respective clinics will be invited to answer questions regarding experiences of delivering the program.
The treatments are evaluated quantitatively by the parents using validated assessment forms/single questions before, during, and after interventions. Additionally, qualitative interviews will be conducted with parents and clinicians who provide consent to participating in an interview.
In another, separate study we evaluate CBT and role-plays in VR for children: "Pilot study of cognitive behavior therapy with role-plays in virtual reality for children with anger problems".
POWER CALCULATION:
The quantitative and qualitative data that will be collected with ten families is considered sufficient to provide understanding and preliminary insight into acceptability, usability, relevance, and effectiveness.
ANALYSES:
The plan is to compare changes during the intervention using paired t-tests, descriptive statistics, description of reliable and clinical change, and calculation of effect sizes. If appropriate, non-parametric alternatives will be employed. The qualitative analyses will be conducted using content analysis or thematic analysis.
- Conditions
- Child Behavior Problem, Disruptive Behavior, Oppositional Defiant Disorder, Conduct Problems, Aggression, Parent-Child Relations
- Being tested
- Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality
- Keywords
- Disruptive Behavior, Child Behavior Problem, Parenting, Virtual Reality
- Medical subject headings
- Problem Behavior, Oppositional Defiant Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-by-step: A cognitive behavioral parent program with role-plays in virtual realityBehavioural
A parent training program based on social learning theory and cognitive behavioral therapy (CBT), incorporating virtual reality for training in brief role plays. The program includes similar strategies as other common CBT-parent training programs for parents of children with behavior problems, with the difference that virtual reality is used as an additional way to practice skills.
| Study group | Role | What they receive |
|---|---|---|
| Parent training with cognitive behavior therapy and virtual reality | Experimental | A parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parent Receives: Behavioral: Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
The Disruptive Behavior Disorder subscale "Oppositional defiant disorder" is used for assessing children's behavioral problems. The subscale includes 8 items which are rated on a 4-point scale (0 to 3). The scale sum ranges från 0 to a total maximum sum of 24. A higher score indicates more behavior problems.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
The Parenting Children and Adolescent Scale has three subscales: encouragement of positive behaviors, setting limits, proactive parenting behaviors. The 21 items are scored on a 5-point scale (1 to 5) and the total scale sum ranges from 21 to a maximum of 105, with a higher score indicating more positive parenting.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale: Impact scale
The 21 items included in the Parenting Children and Adolescents Scale each include a question of whether the item is experienced as a problem (yes/no). Total scale sum ranges between 0 and 21 with a higher sum indicating larger impact.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Secondary outcomes (13)
Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10
The KIDSCREEN-10 evaluates how parents perceive their child's/adolescent's health and well-being. The 10 items are scored on a 5-point scale (1 to 5). The total maximum sum ranges between 10 and 50 with a higher score indicating greater child wellbeing and health-related quality of life. The scale also includes an overall question about how the child is feeling in general.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire (SDQ) is used to assess mental health through a total difficulties score as well as through the five subscales (peer relationship problems, prosocial behavior, emotional symptoms, hyperactivity/inattention, conduct problems). The items are scored on a 3-point scale (0 to 2), and the total difficulties score is generated by summing all subscales except the prosocial scale. The summary score ranges from 0 to 40. Higher summary scores indicate more problems.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale-16
General emotion regulation ability will be measured with the Difficulties in Emotion Regulation Scale (brief version). The 16 items are scored on a 5-point scale (1 to 5), and the total summary score ranges between 16 and 80. A higher score indicates larger difficulties with emotion regulation.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
Emotion regulation of the parent will be measured with the Parent Emotion Regulation Scale. The 20 items are scored on a 5-point scale (1 to 5). A total summary score ranges between 20 and 100 where a higher score indicates better regulation of emotions.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change in parent-ratings of family warmth
Family warmth is measured with 5 questions from the Family Check-Up Caregiver Assessment Scale. These are scored on a 5-point scale (1 to 5). Total maximum score ranges between 5 and 25. A higher score indicates a more positive relation.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change in parent-ratings of family conflicts
Family conflicts are measured with 3 questions from the Family Check-Up Caregiver Assessment Scale. These are scored on a 7-point scale (0 to 6). Total maximum score ranges between 0 and 18. A higher score indicates larger degree of conflicts.
Measured: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change in parent-ratings of parental satisfaction with the week
Three questions scored 0 to 10 about parents' satisfaction with the week, with how they have been able to support their child and manage conflicts. Total maximum score ranges between 0-30, with a higher score indicating higher satisfaction.
Measured: From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.
Parent: Parental experiences of each session
Four questions after each session about how the parent experienced the session and exercises. Rated on a scale 0-10, with a maximum total score ranging between 0 and 40. A higher score indicates greater satisfaction with the session.
Measured: From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.
Parent: Closing questions about the intervention
Closing questions to parents about satisfaction, relevance, and usefulness of the intervention. Parents respond to six questions rated on a scale 0-10, with a maximum total score ranging between 0 and 60. A higher score indicates greater satisfaction.
Measured: Post-intervention (measured 6 to 10 weeks after the initiation of the intervention)
Use of the parent program: number of sessions, homework tasks, exercises
A summary of the mean number of sessions, homework tasks and exercises completed during the program.
Measured: From pre- to post-intervention (10 weeks after the initiation of the intervention)
Use of the parent program: drop out rate
The drop out from the program (number of participants).
Measured: From pre- to post-intervention (10 weeks after the initiation of the intervention)
Clinicians: Clinician perception of implementation
Clinicians will respond to two questions rated 0-10 after each session about their implementation of the treatment session, higher scores indicating higher satisfaction (maximum weekly mean score is 20).
Measured: From pre- to post-intervention (during 6-10 weeks).
Parent, clinician: Experiences of the parenting program explored through separate, individual qualitative interviews with parent and clinician
Qualitative interviews will explore parent's and clinician's experiences of the treatment. We will investigate satisfaction, feasibility, acceptability, and relevance of the program. The interviews with parents are partly based on an established scale, modified for this purpose, and self-constructed questions. Interviews with clinicians are based on self-constructed oral questions examining acceptability, relevance, feasibility and satisfaction.
Measured: Interviews are conducted after the program is completed, 10 weeks after the initiation of each program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start27 Aug 2024
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- PRIMA, Psykologpartners
- Responsible party
- Principal investigator, Pia Enebrink, Karolinska Institutet
- Investigators
- Pia Enebrink, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559813
- Sponsor's protocol ID
- 2024-00813-01 - Parents
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Parents of Children With Anger, Oppositional or Aggressive Behaviors
- ClinicalTrials.gov ID
- NCT06559813
- Acronym / sponsor ID
- 2024-00813-01 - Parents
- Conditions
- Child Behavior Problem, Disruptive Behavior, Oppositional Defiant Disorder, Conduct Problems, Aggression, Parent-Child Relations
- Keywords
- Disruptive Behavior, Child Behavior Problem, Parenting, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- PRIMA, Psykologpartners
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 19 Aug 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 main aim of this pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). The parent training program is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR).
The main questions the project aims to answer are:
- What are the preliminary effects of the CBT-VR parent training program?
- What is the level of parent engagement in the CBT-VR parent training program?
- What are the experiences of parents and therapists of the CBT-VR parent training program?
The CBT-VR parenting program is delivered at clinics during individual sessions. Parents will answer quantitative measurements before, during, and after treatment. Within-group analyses will be conducted to examine experiences and preliminary effects of the program. Parents and clinicians are also asked to participate in a qualitative interview after the program has ended.
Detailed description
BACKGROUND:
Parent training programs based on cognitive behavioral therapy (CBT) have shown positive effects for reducing child behavior problems, such as oppositional defiant and aggressive behaviors, and are often recommended as a first intervention. The focus of CBT-based parenting programs are e.g. to reduce negative parent-child interactions and increase positive communication.
Recently, studies have evaluated CBT with the addition of exercises and role-playing in virtual reality (VR), for instance for adults with anxiety or anger. VR can provide a safe and gradual platform to practice in environments and situations. The present project evaluates a CBT-based parenting program, which includes practicing of skills in VR.
PURPOSE AND RESEARCH QUESTIONS:
The aim of this project is to evaluate preliminary effects and feasibility of a CBT-VR parent training program. The specific research questions are as follows:
- What are the preliminary effect of the CBT-VR parent training program on children's behavioral problems, well-being, parents' emotion regulation, parenting strategies, and family conflicts?
- What is the level of parent engagement in the CBT-VR parent training program (e.g., the number of sessions, exercises, homework completion and dropout rates)?
- What are the experiences of parents and therapists of the CBT-VR parent training program (e.g., its effectiveness, acceptability, usefulness as well as relevance of the strategies taught)?
METHODS:
This project consists of a small pilot study of a CBT-VR parent training program for parents with children aged 8-16 years (n=10 families). The design is based on a mixed-methods approach. Evaluation of the intervention is conducted using within-group design (repeated measurements before, during, and after the intervention).
Parents will be recruited through clinics and advertisements. They are directed to a webpage with information about the study and contact information to the researchers. Parents give written informed consent to participate. When parents are interested in participating, a member of the research team will contact the participant for screening of inclusion and exclusion criteria. Clinicians at the respective clinics will be invited to answer questions regarding experiences of delivering the program.
The treatments are evaluated quantitatively by the parents using validated assessment forms/single questions before, during, and after interventions. Additionally, qualitative interviews will be conducted with parents and clinicians who provide consent to participating in an interview.
In another, separate study we evaluate CBT and role-plays in VR for children: "Pilot study of cognitive behavior therapy with role-plays in virtual reality for children with anger problems".
POWER CALCULATION:
The quantitative and qualitative data that will be collected with ten families is considered sufficient to provide understanding and preliminary insight into acceptability, usability, relevance, and effectiveness.
ANALYSES:
The plan is to compare changes during the intervention using paired t-tests, descriptive statistics, description of reliable and clinical change, and calculation of effect sizes. If appropriate, non-parametric alternatives will be employed. The qualitative analyses will be conducted using content analysis or thematic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent training with cognitive behavior therapy and virtual reality | Experimental | Behavioral: Step-by-step: A cognitive behavioral parent program with role-plays in virtual realityA parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parent |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent of a child aged 8-16 years
- The parent perceives that the child has oppositional, angry or aggressive behaviors, and/or that there are parent-child conflicts at home.
- The child's behavior is elevated on a measure targeting behavioral problems (SDQ conduct problems subscale)
Key exclusion criteria (5 listed)
- Parent of a child under 8 years or over 16 years of age
- The child does not currently exhibit oppositional, angry or aggressive behaviors
- Child diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors
- Parent has epilepsy or migraine
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 |
|---|---|---|
| Step-by-step: A cognitive behavioral parent program with role-plays in virtual realityA parent training program based on social learning theory and cognitive behavioral therapy (CBT), incorporating virtual reality for training in brief role plays. The program includes similar strategies as other common CBT-parent training programs for parents of children with behavior problems, with the difference that virtual reality is used as an additional way to practice skills. | Behavioural | Parent training with cognitive behavior therapy and virtual reality |
Primary outcome
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
The Disruptive Behavior Disorder subscale "Oppositional defiant disorder" is used for assessing children's behavioral problems. The subscale includes 8 items which are rated on a 4-point scale (0 to 3). The scale sum ranges från 0 to a total maximum sum of 24. A higher score indicates more behavior problems.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
The Parenting Children and Adolescent Scale has three subscales: encouragement of positive behaviors, setting limits, proactive parenting behaviors. The 21 items are scored on a 5-point scale (1 to 5) and the total scale sum ranges from 21 to a maximum of 105, with a higher score indicating more positive parenting.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale: Impact scale
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
The 21 items included in the Parenting Children and Adolescents Scale each include a question of whether the item is experienced as a problem (yes/no). Total scale sum ranges between 0 and 21 with a higher sum indicating larger impact.
13 secondary outcomes
Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale-16
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change in parent-ratings of family warmth
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change in parent-ratings of family conflicts
Time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Parent: Mean change in parent-ratings of parental satisfaction with the week
Time frame: From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.
Parent: Parental experiences of each session
Time frame: From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.
Parent: Closing questions about the intervention
Time frame: Post-intervention (measured 6 to 10 weeks after the initiation of the intervention)
Use of the parent program: number of sessions, homework tasks, exercises
Time frame: From pre- to post-intervention (10 weeks after the initiation of the intervention)
Use of the parent program: drop out rate
Time frame: From pre- to post-intervention (10 weeks after the initiation of the intervention)
Clinicians: Clinician perception of implementation
Time frame: From pre- to post-intervention (during 6-10 weeks).
Parent, clinician: Experiences of the parenting program explored through separate, individual qualitative interviews with parent and clinician
Time frame: Interviews are conducted after the program is completed, 10 weeks after the initiation of each program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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. This study is not recruiting at the moment.
Pia Enebrink principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality in people with Child Behavior Problem and Disruptive Behavior, run by Karolinska Institutet at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale). (time frame: Pre- and post-intervention (10 weeks after the initiation of the intervention)). The study lists 3 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 18 Sep 2026.