Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems

NCT ID: NCT06559813

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2024-11-30

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.

Conditions

Child Behavior Problem; Disruptive Behavior; Oppositional Defiant Disorder; Conduct Problems; Aggression; Parent-Child Relations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parent training with cognitive behavior therapy and virtual reality

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

Group Type: EXPERIMENTAL

Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality

Intervention Type: BEHAVIORAL

A parent training program based on social learning theory and cognitive behavioral therapy (CBT), incorporating virtual reality for training in brief role plays. The program includes similar strategies as other common CBT-parent training programs for parents of children with behavior problems, with the difference that virtual reality is used as an additional way to practice skills.

Interventions

Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality

A parent training program based on social learning theory and cognitive behavioral therapy (CBT), incorporating virtual reality for training in brief role plays. The program includes similar strategies as other common CBT-parent training programs for parents of children with behavior problems, with the difference that virtual reality is used as an additional way to practice skills.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRIMA

UNKNOWN

Sponsor Role: collaborator

Psykologpartners

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Pia Enebrink

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Enebrink

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Central Contacts

Pia Enebrink, PhD

Role: CONTACT

pia.enebrink@ki.se

+46852487738

Other Identifiers

2024-00813-01 - Parents

Identifier Type: -

Identifier Source: org_study_id