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针对有行为问题的儿童进行虚拟现实角色扮演认知行为治疗的试点研究

2026年9月15日 更新者:Pia Enebrink、Karolinska Institutet

循序渐进 - 针对有愤怒、对抗或攻击行为的儿童的虚拟现实角色扮演认知行为疗法试点研究

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.

研究概览

详细说明

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:

  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.

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Solna、瑞典
        • Karolinska Institutet

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 16年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
大体时间: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.

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
大体时间: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.

Pre- and post-intervention (10 weeks after the initiation of the intervention)

次要结果测量

结果测量
措施说明
大体时间
Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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)
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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)
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:Pre- and post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:From pre- to post-intervention (measured after 10 weeks)

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
大体时间:From pre- to post-intervention (measured after 10 weeks)

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
大体时间:From pre- to post-intervention (during 10 weeks). Completed once a week at the session.

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
大体时间:From pre- to post-intervention (during 10 weeks). Completed once a week at the session.

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
大体时间:From pre- to post-intervention (during 10 weeks). Completed once a week at the 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
大体时间:Post-intervention (10 weeks after the initiation of 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
大体时间:From pre- to post-intervention (measured after 10 weeks)

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
大体时间:Interviews are conducted after the program is completed, about 10 weeks after the initiation of the program

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
大体时间:From pre- to post-intervention (10 weeks after the initiation of the intervention)

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
大体时间:From pre- to post-intervention (10 weeks after the initiation of the intervention)

The drop out from the program (number of participants)

From pre- to post-intervention (10 weeks after the initiation of the intervention)

其他结果措施

结果测量
措施说明
大体时间
Background information - parent
大体时间:Pre-intervention

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
大体时间:Pre-intervention

Children are asked three demographic questions about themselves (e.g., age).

Pre-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Pia Enebrink, PhD、Karolinska Institutet

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月9日

初级完成 (实际的)

2026年4月3日

研究完成 (实际的)

2026年4月3日

研究注册日期

首次提交

2024年8月14日

首先提交符合 QC 标准的

2024年8月15日

首次发布 (实际的)

2024年8月19日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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