Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Anger, Oppositional or Aggressive Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
研究概览
简要总结
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.
详细描述
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. 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:
- 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?
- What is the level of child engagement in the CBT-VR program (e.g., the number of sessions, homework completion and dropout rates)?
- 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)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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
干预措施: YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality (Behavioral)
结局指标
主要结局
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
时间窗: Pre- and post-intervention (10 weeks after the initiation of the intervention)
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.
Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children
时间窗: Pre- and post-intervention (10 weeks after the initiation of the intervention)
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.
次要结局
- Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10(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)(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(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)(Pre- and post-intervention (10 weeks after the initiation of the intervention))
- Parent: Mean change in parent-ratings of family warmth(Pre- and post-intervention (10 weeks after the initiation of the intervention))
- Parent: Mean change in parent-ratings of family 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(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(Pre- and post-intervention (10 weeks after the initiation of the intervention))
- Child/youth: Satisfaction with the week(From pre- to post-intervention (during 10 weeks). Completed once a week at the session.)
- Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire(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(From pre- to post-intervention (measured after 10 weeks))
- Child/youth: Child experiences of each session(From pre- to post-intervention (during 10 weeks). Completed once a week at the session)
- Parent, child/youth, clinician: Experiences of the child/youth program through individual qualitative interviews with parent, youth or clinician(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(From pre- to post-intervention (10 weeks after the initiation of the intervention))
- Child/youth: Presence of anger or conflicts(From pre- to post-intervention (during 10 weeks). Completed once a week at the session.)
- Child/youth: Closing questions about the intervention(Post-intervention (10 weeks after the initiation of the intervention))
- Clinicians: Clinician perception of treatment implementation(From pre- to post-intervention (measured after 10 weeks))
- Drop-out rate(From pre- to post-intervention (10 weeks after the initiation of the intervention))
研究者
Pia Enebrink
Associate professor
Karolinska Institutet