Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems
NCT Number: NCT06559800
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Behavior Problem|Disruptive Behavior|Oppositional Defiant Disorder|Conduct Problems|Aggression|Anger
Interventions: BEHAVIORAL: YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality
Sponsor: Karolinska Institutet
Collaborators: PRIMA|Psykologpartners
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2024-11-30

Summary:
The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior (e.g., enhanced anger or aggressive behavior) when evaluated in Sweden for children/youth aged 10-16 years. YourSkills 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 child/youth CBT-VR-program?
* What is the level of child/youth engagement in the CBT-VR program?
* What are the experiences of parents, children/youth and therapists of the program?

The CBT-VR program is delivered at clinics during ten individual sessions. Parents will answer quantitative measurements before and after treatment, children 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, children and clinicians are also asked to participate in a qualitative interview after the program has ended.

Primary Outcome Measures: Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale)., The oppositional defiant disorder subscale of the Disruptive Behavior Disorder scale 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 total scale sum ranges från 0 to a total maximum sum of 24 with a higher score indicating more behavior problems., Pre- and post-intervention (10 weeks after the initiation of the intervention)|Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children, The Anger expression scale for children includes 26 questions about anger and anger management and is rated by children on a 4-point Likert scale (from 1 to 4). We use two modified sub-scales: anger expression (score ranges from 17 to 68) and anger control (score ranges from 9 to 36) with higher scores indicating higher levels of anger expression and anger control., Pre- and post-intervention (10 weeks after the initiation of the intervention)
Secondary Outcome Measures: Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10, The KIDSCREEN has 10 items and evaluates how parents perceive the health and well-being of their child or adolescent. The items are scored on a 5-point scale (1-5). A total maximum sum ranges between 10 and 50, and a higher score indicates greater child wellbeing and health-related quality of life. The scale also includes an overall question about how the child is feeling in general., 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) assesses mental health through five subscales (peer relationship problems, prosocial behavior, emotional symptoms, hyperactivity/ inattention, conduct problems) and a total difficulties score. 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 where higher summary scores indicate more problems., 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 (brief version), Parents' general emotion regulation ability will be measured with the Difficulties in Emotion Regulation Scale-16. The 16 items are scored on a 5-point scale (1 to 5). The total summary score ranges between 16 and 80, a higher score indicating larger difficulties with emotion regulation., 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, Parental emotion regulation will be measured with 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, with a higher score indicating better regulation of emotions., 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. The items 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., Pre- and post-intervention (10 weeks after the initiation of the intervention)|Parent: Mean change in parent-ratings of family conflicts, Three questions from the Family Check-Up Caregiver Assessment Scale are used to measure family conflicts. The items are scored on a 7-point scale (0 to 6), with total maximum score ranging between 0 and 18. A higher score indicates larger degree of conflicts., 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 three sub-scales of the Parenting Children and Adolescents Scale are Encouragement of positive behaviors; Setting limits; Proactive parenting behaviors. The 21 items are scored on a 5-point scale (1 to 5). The total scale sum ranges from 21 to a maximum of 105. A higher score indicates more positive parenting behaviors., 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, For each of the 21 items of the Parenting Children and Adolescents Scale the parent also indicates whether the item is experienced as a problem (yes/no). Total scale sum ranges between 0 and 21, with a higher sum indicating more problems and impact., Pre- and post-intervention (10 weeks after the initiation of the intervention)|Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire, Child-ratings of Strengths and Difficulties Questionnaire are 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 where higher summary scores indicate more severe problems., From pre- to post-intervention (measured after 10 weeks)|Child/youth: Mean change from baseline in child-ratings of child wellbeing on the KIDSCREEN-10, The instrument evaluates how children perceive their 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., From pre- to post-intervention (measured after 10 weeks)|Child/youth: Satisfaction with the week, One question rated 0-10 measuring satisfaction with the week. Higher levels indicate larger satisfaction., From pre- to post-intervention (during 10 weeks). Completed once a week at the session.|Child/youth: Presence of anger or conflicts, Two questions, each rated 0-10 (maximum score between 0- 20), measuring presence of anger or conflicts. Higher levels indicate larger anger problems/conflicts., From pre- to post-intervention (during 10 weeks). Completed once a week at the session.|Child/youth: Child experiences of each session, Four questions after each session about how the child experienced the sessions 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., From pre- to post-intervention (during 10 weeks). Completed once a week at the session|Child/youth: Closing questions about the intervention, Five closing questions about satisfaction, relevance, and usefulness of the intervention. The questions are rated on a 0-10-scale, total score is 50, with higher score indicating larger satisfaction., Post-intervention (10 weeks after the initiation of the intervention)|Clinicians: Clinician perception of treatment implementation, Clinicians conducting treatments will respond to two questions every week about treatment implementation. The questions are rated 0-10 (maximum weekly mean score 20), with higher scores indicating larger satisfaction., From pre- to post-intervention (measured after 10 weeks)|Parent, child/youth, clinician: Experiences of the child/youth program through individual qualitative interviews with parent, youth or clinician, Qualitative interviews will explore parent's, child's/youth's and clinician's experiences of the treatment. We will investigate satisfaction, feasibility, acceptability, and relevance of the programs. The interview with parents is partly based on an established scale, modified for this purpose, and self-constructed questions. Interviews with clinicians and children are based on self-constructed questions examining acceptability, relevance, feasibility and satisfaction., Interviews are conducted after the program is completed, about 10 weeks after the initiation of the program|Use of the child/youth program: number of sessions, homework tasks, A summary of the mean number of sessions and homework tasks completed during the program., From pre- to post-intervention (10 weeks after the initiation of the intervention)|Drop-out rate, The drop out from the program (number of participants), From pre- to post-intervention (10 weeks after the initiation of the intervention)
Other Outcome Measures: Background information - parent, Parents are asked for brief demographic information about themselves (e.g., age, education) and their child (e.g. age). A total of 8 questions., Pre-intervention|Background information - child, Children are asked three demographic questions about themselves (e.g., age)., Pre-intervention