Clinical trial NCT06559800: Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems
Official title: Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Anger, Oppositional or Aggressive Behaviors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Behavior Problem
Disruptive Behavior
Oppositional Defiant Disorder
Conduct Problems
Aggression
Anger
Keywords: Disruptive behavior
Child behavior problems
Cognitive behavior therapy
Virtual reality
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: PRIMA
name: Psykologpartners
First posted: 2024-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cognitive behavioral therapy (CBT) for children with behavior problems often include anger management training, social skills training, and problem-solving training. These have been shown to reduce anger and aggressive behaviors with small to moderate effects.

In a study in the Netherlands, the CBT-VR treatment program YourSkills was developed and evaluated for boys with aggressive behavior aged 8-13 years (Alsem et al, 2023). The treatment builds on CBT and includes brief role-plays conducted in virtual reality (VR). VR can provide a safe and gradual platform to practice.

PURPOSE AND RESEARCH QUESTIONS:

The aim of the pilot study is to evaluate preliminary effects and feasibility of the CBT-VR program YourSkills in Sweden for children/youth aged 10-16. The specific research questions are as follows:

1. What are the preliminary effects of the CBT-VR program on children's behavioral problems, well-being, parents' emotion regulation, parenting strategies, and family conflicts?
2. What is the level of child engagement in the CBT-VR program (e.g., the number of sessions, homework completion and dropout rates)?
3. What are the experiences of parents, children and therapists of the 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 the CBT-based program YourSkills.

In the present project we target children/youth aged 10-16 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).

Families will be recruited through clinics and advertisements. They are directed to a webpage with information about the study and contact information to the researchers. Families provide informed consent to participate. Upon a participant expressing interest of the study, a member of the research team will contact the participant for a screening of inclusion and exclusion criteria.

The treatment is evaluated quantitatively by parents and children, using validated assessment scales before and after treatment, and by children with single questions before, during, and after the intervention. Additionally, qualitative interviews will be conducted with participants who consent to participate in an interview. Interviews will be recorded and transcribed. Clinicians at the clinics are invited to answer questions regarding their experiences of delivering the program.

In another separate pilot study we evaluate parent training with role-plays in virtual reality: "Pilot study of parent training with role-plays in virtual reality for parents of children with behavior problems".

POWER CALCULATION:

The quantitative and qualitative data that will be collected for 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.

Eligibility criteria: Inclusion Criteria:

* Child/youth aged between 10-16 years with increased levels of anger or disruptive behaviors,
* The child's behavior problems is elevated on questions targeting behavioral problems (SDQ conduct problems subscale).

Exclusion Criteria:

* Child/youth is below 10 years or above 16 years of age
* No increased levels of anger or disruptive behaviors
* Child/youth is diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors
* Child/youth has epilepsy or migraine

Primary outcomes:
measure: Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Secondary outcomes:
measure: Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale (brief version)
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change in parent-ratings of family warmth
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change in parent-ratings of family conflicts
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale: Impact scale
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire
timeFrame: From pre- to post-intervention (measured after 10 weeks)
measure: Child/youth: Mean change from baseline in child-ratings of child wellbeing on the KIDSCREEN-10
timeFrame: From pre- to post-intervention (measured after 10 weeks)
measure: Child/youth: Satisfaction with the week
timeFrame: From pre- to post-intervention (during 10 weeks). Completed once a week at the session.
measure: Child/youth: Presence of anger or conflicts
timeFrame: From pre- to post-intervention (during 10 weeks). Completed once a week at the session.
measure: Child/youth: Child experiences of each session
timeFrame: From pre- to post-intervention (during 10 weeks). Completed once a week at the session
measure: Child/youth: Closing questions about the intervention
timeFrame: Post-intervention (10 weeks after the initiation of the intervention)
measure: Clinicians: Clinician perception of treatment implementation
timeFrame: From pre- to post-intervention (measured after 10 weeks)
measure: Parent, child/youth, clinician: Experiences of the child/youth program through individual qualitative interviews with parent, youth or clinician
timeFrame: Interviews are conducted after the program is completed, about 10 weeks after the initiation of the program
measure: Use of the child/youth program: number of sessions, homework tasks
timeFrame: From pre- to post-intervention (10 weeks after the initiation of the intervention)
measure: Drop-out rate
timeFrame: From pre- to post-intervention (10 weeks after the initiation of the intervention)
Other outcomes:
measure: Background information - parent
timeFrame: Pre-intervention
measure: Background information - child
timeFrame: Pre-intervention
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Pia Enebrink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alsem SC, van Dijk A, Verhulp EE, Dekkers TJ, De Castro BO. Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. Child Dev. 2023 Nov-Dec;94(6):e344-e361. doi: 10.1111/cdev.13966. Epub 2023 Jul 17.