An interventional study of Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality in Child Behavior Problem, Disruptive Behavior and Oppositional Defiant Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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:
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.
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:
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.
178 studies on the registry are indexed under Problem Behavior; 47 are open to participants now.
This study's enrollment of 8 is below the median of 90 across 165 interventional studies indexed under Problem Behavior.
Browse Problem Behavior studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parents:
EXCLUSION CRITERIA
Parent treatment:
A parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parent
Behavioral: Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality
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.
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.
Time frame: 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.
Time frame: 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.
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 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.
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)
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
A summary of the mean number of sessions, homework tasks and exercises completed during the program.
Time frame: 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).
Time frame: 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).
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
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.
Time frame: Interviews are conducted after the program is completed, 10 weeks after the initiation of each program
Background information
Parents are asked for concise demographic information about themselves (e.g., age, education) and their child (e.g., age). A total of 8 questions.
Time frame: Pre-intervention
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.