Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems

Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Anger, Oppositional or Aggressive Behaviors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anger; Aggression; Child Behavior Problem; Oppositional Defiant Disorder; Disruptive Behavior; Conduct Problems
• Intervention / Treatment: Behavioral: YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pia Enebrink, PhD; Phone Number: +46852487738; Email: pia.enebrink@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cognitive behavior therapy for children and youth with role-plays in virtual reality; Child/youth cognitive-behavioral program with up to 10 individual, face-to-face, weekly sessions

Behavioral: YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality; A program for children/youth with anger problems or aggressive behaviors based on social learning theory and cognitive behavior therapy (CBT), incorporating virtual reality (VR) when conducting brief role-plays. The program includes similar strategies as other CBT-oriented programs for anger problems, with the addition of VR for practicing skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Psykologpartners; PRIMA
• Investigators: Principal Investigator: Pia Enebrink, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 19, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive behavior therapy; Virtual reality; Disruptive behavior; Child behavior problems
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Aberrant Motor Behavior in Dementia; Aggression; Problem Behavior; Oppositional Defiant Disorder
• Other Study ID Numbers: 2024-00813-01 - Children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No