Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559800
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Anger Oppositional or Aggressive Behaviors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior eg enhanced anger or aggressive behavior when evaluated in Sweden for childrenyouth 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 childyouth CBT-VR-program
What is the level of childyouth engagement in the CBT-VR program
What are the experiences of parents childrenyouth 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
The main questions the project aims to answer are
What are the preliminary effects of the childyouth CBT-VR-program
What is the level of childyouth engagement in the CBT-VR program
What are the experiences of parents childrenyouth 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
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 childrenyouth aged 10-16 The specific research questions are as follows
1 What are the preliminary effects of the CBT-VR program on childrens 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 eg the number of sessions homework completion and dropout rates
3 What are the experiences of parents children and therapists of the program eg 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 childrenyouth aged 10-16 years n10 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
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 childrenyouth aged 10-16 The specific research questions are as follows
1 What are the preliminary effects of the CBT-VR program on childrens 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 eg the number of sessions homework completion and dropout rates
3 What are the experiences of parents children and therapists of the program eg 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 childrenyouth aged 10-16 years n10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None