Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559813
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of 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 Parents of 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 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 eg 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
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
Detailed Description:
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 eg 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
1 What are the preliminary effect of the CBT-VR parent training program on childrens behavioral problems well-being parents emotion regulation parenting strategies and family conflicts
2 What is the level of parent engagement in the CBT-VR parent training program eg the number of sessions exercises homework completion and dropout rates
3 What are the experiences of parents and therapists of the CBT-VR parent training program eg its effectiveness acceptability usefulness as well as relevance of the strategies taught
METHODS
This project consists of a small pilot study of a CBT-VR parent training program for parents with children aged 8-16 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
Parents will be recruited through clinics and advertisements They are directed to a webpage with information about the study and contact information to the researchers Parents give written informed consent to participate When parents are interested in participating a member of the research team will contact the participant for screening of inclusion and exclusion criteria Clinicians at the respective clinics will be invited to answer questions regarding experiences of delivering the program
The treatments are evaluated quantitatively by the parents using validated assessment formssingle questions before during and after interventions Additionally qualitative interviews will be conducted with parents and clinicians who provide consent to participating in an interview
In another separate study we evaluate CBT and role-plays in VR for children Pilot study of cognitive behavior therapy with role-plays in virtual reality for children with anger problems
POWER CALCULATION
The quantitative and qualitative data that will be collected with 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
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 eg 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
1 What are the preliminary effect of the CBT-VR parent training program on childrens behavioral problems well-being parents emotion regulation parenting strategies and family conflicts
2 What is the level of parent engagement in the CBT-VR parent training program eg the number of sessions exercises homework completion and dropout rates
3 What are the experiences of parents and therapists of the CBT-VR parent training program eg its effectiveness acceptability usefulness as well as relevance of the strategies taught
METHODS
This project consists of a small pilot study of a CBT-VR parent training program for parents with children aged 8-16 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
Parents will be recruited through clinics and advertisements They are directed to a webpage with information about the study and contact information to the researchers Parents give written informed consent to participate When parents are interested in participating a member of the research team will contact the participant for screening of inclusion and exclusion criteria Clinicians at the respective clinics will be invited to answer questions regarding experiences of delivering the program
The treatments are evaluated quantitatively by the parents using validated assessment formssingle questions before during and after interventions Additionally qualitative interviews will be conducted with parents and clinicians who provide consent to participating in an interview
In another separate study we evaluate CBT and role-plays in VR for children Pilot study of cognitive behavior therapy with role-plays in virtual reality for children with anger problems
POWER CALCULATION
The quantitative and qualitative data that will be collected with 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