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临床试验/NCT06559813
NCT06559813已完成不适用

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

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
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 pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). The parent training program 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 CBT-VR parent training program?
  • What is the level of parent engagement in the CBT-VR parent training program?
  • What are the experiences of parents and therapists of the CBT-VR parent training program?

The CBT-VR parenting program is delivered at clinics during individual sessions. Parents 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 and clinicians are also asked to participate in a qualitative interview after the program has ended.

详细描述

BACKGROUND:

Parent training programs based on cognitive behavioral therapy (CBT) have shown positive effects for reducing child behavior problems, such as oppositional defiant and aggressive behaviors, and are often recommended as a first intervention. The focus of CBT-based parenting programs are e.g. to reduce negative parent-child interactions and increase positive communication.

Recently, studies have evaluated CBT with the addition of exercises and role-playing in virtual reality (VR), for instance for adults with anxiety or anger. VR can provide a safe and gradual platform to practice in environments and situations. The present project evaluates a CBT-based parenting program, which includes practicing of skills in VR.

PURPOSE AND RESEARCH QUESTIONS:

The aim of this project is to evaluate preliminary effects and feasibility of a CBT-VR parent training program. The specific research questions are as follows:

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parent of a child aged 8-16 years
  • The parent perceives that the child has oppositional, angry or aggressive behaviors, and/or that there are parent-child conflicts at home.
  • The child's behavior is elevated on a measure targeting behavioral problems (SDQ conduct problems subscale)

排除标准

  • Parent treatment:
  • Parent of a child under 8 years or over 16 years of age
  • The child does not currently exhibit oppositional, angry or aggressive behaviors
  • Child diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors
  • Parent has epilepsy or migraine

研究组 & 干预措施

Parent training with cognitive behavior therapy and virtual reality

Experimental

A parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parent

干预措施: Step-by-step: A cognitive behavioral parent program 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 Disruptive Behavior Disorder subscale "Oppositional defiant disorder" 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 scale sum ranges från 0 to a total maximum sum of 24. A higher score indicates more behavior problems.

Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale

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

The Parenting Children and Adolescent Scale has three subscales: encouragement of positive behaviors, setting limits, proactive parenting behaviors. The 21 items are scored on a 5-point scale (1 to 5) and the total scale sum ranges from 21 to a maximum of 105, with a higher score indicating more positive parenting.

Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale: Impact scale

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

The 21 items included in the Parenting Children and Adolescents Scale each include a question of whether the item is experienced as a problem (yes/no). Total scale sum ranges between 0 and 21 with a higher sum indicating larger impact.

次要结局

  • 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 in parent-ratings of family warmth(Pre- and post-intervention (10 weeks after the initiation of the intervention))
  • Clinicians: Clinician perception of implementation(From pre- to post-intervention (during 6-10 weeks).)
  • Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale-16(Pre- and post-intervention (10 weeks after the initiation of the intervention))
  • Parent: Parental experiences of each session(From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.)
  • 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))
  • Use of the parent program: number of sessions, homework tasks, exercises(From pre- to post-intervention (10 weeks after the initiation of the intervention))
  • Use of the parent program: drop out rate(From pre- to 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 in parent-ratings of parental satisfaction with the week(From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.)
  • Parent: Closing questions about the intervention(Post-intervention (measured 6 to 10 weeks after the initiation of the intervention))
  • Parent, clinician: Experiences of the parenting program explored through separate, individual qualitative interviews with parent and clinician(Interviews are conducted after the program is completed, 10 weeks after the initiation of each program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pia Enebrink

Associate professor

Karolinska Institutet

研究点 (1)

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