Clinical trial NCT06559813: Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Behavior Problem
Disruptive Behavior
Oppositional Defiant Disorder
Conduct Problems
Aggression
Parent-Child Relations
Keywords: Disruptive Behavior
Child Behavior Problem
Parenting
Virtual Reality
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: PRIMA
name: Psykologpartners
First posted: 2024-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.

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 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:

1. What are the preliminary effect of the CBT-VR parent training program on children's 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 (e.g., 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 (e.g., 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 (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).

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 forms/single 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.

Eligibility criteria: INCLUSION CRITERIA:

Parents:

* 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)

EXCLUSION CRITERIA

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

Primary outcomes:
measure: Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale: Impact scale
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
Secondary outcomes:
measure: Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale-16
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change in parent-ratings of family warmth
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change in parent-ratings of family conflicts
timeFrame: Pre- and post-intervention (10 weeks after the initiation of the intervention)
measure: Parent: Mean change in parent-ratings of parental satisfaction with the week
timeFrame: From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.
measure: Parent: Parental experiences of each session
timeFrame: From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.
measure: Parent: Closing questions about the intervention
timeFrame: Post-intervention (measured 6 to 10 weeks after the initiation of the intervention)
measure: Use of the parent program: number of sessions, homework tasks, exercises
timeFrame: From pre- to post-intervention (10 weeks after the initiation of the intervention)
measure: Use of the parent program: drop out rate
timeFrame: From pre- to post-intervention (10 weeks after the initiation of the intervention)
measure: Clinicians: Clinician perception of implementation
timeFrame: From pre- to post-intervention (during 6-10 weeks).
measure: Parent, clinician: Experiences of the parenting program explored through separate, individual qualitative interviews with parent and clinician
timeFrame: Interviews are conducted after the program is completed, 10 weeks after the initiation of each program
Other outcomes:
measure: Background information
timeFrame: Pre-intervention
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Pia Enebrink
role: PRINCIPAL_INVESTIGATOR
References: