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행동 문제가 있는 아동을 위한 가상 현실에서의 역할극을 통한 인지 행동 치료에 대한 파일럿 연구

2026년 9월 15일 업데이트: Pia Enebrink, Karolinska Institutet

단계별 - 분노, 반대 또는 공격적 행동이 있는 어린이를 위한 가상 현실에서의 역할극을 통한 인지 행동 치료에 대한 파일럿 연구

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

10

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Solna, 스웨덴
        • Karolinska Institutet

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

10년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Background information - parent
기간: 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
기간: Pre-intervention

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

Pre-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Pia Enebrink, PhD, Karolinska Institutet

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 9월 9일

기본 완료 (실제)

2026년 4월 3일

연구 완료 (실제)

2026년 4월 3일

연구 등록 날짜

최초 제출

2024년 8월 14일

QC 기준을 충족하는 최초 제출

2024년 8월 15일

처음 게시됨 (실제)

2024년 8월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 9월 1일

추가 정보

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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