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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Parent training with cognitive behavior therapy and virtual realityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).

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.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)
2

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

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.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)
3

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

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.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)

Secondary outcomes

1

Parent: Mean change from baseline in parent-ratings of child wellbeing on the KIDSCREEN-10

The KIDSCREEN-10 evaluates how parents perceive their child's/adolescent's health and well-being. The 10 items are scored on a 5-point scale (1 to 5). The total maximum sum ranges between 10 and 50 with a higher score indicating greater child wellbeing and health-related quality of life. The scale also includes an overall question about how the child is feeling in general.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)
2

Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)

The Strengths and Difficulties Questionnaire (SDQ) is used to assess mental health through a total difficulties score as well as through the five subscales (peer relationship problems, prosocial behavior, emotional symptoms, hyperactivity/inattention, conduct problems). The items are scored on a 3-point scale (0 to 2), and the total difficulties score is generated by summing all subscales except the prosocial scale. The summary score ranges from 0 to 40. Higher summary scores indicate more problems.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)
3

Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale-16

General emotion regulation ability will be measured with the Difficulties in Emotion Regulation Scale (brief version). The 16 items are scored on a 5-point scale (1 to 5), and the total summary score ranges between 16 and 80. A higher score indicates larger difficulties with emotion regulation.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)
4

Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale

Emotion regulation of the parent will be measured with the Parent Emotion Regulation Scale. The 20 items are scored on a 5-point scale (1 to 5). A total summary score ranges between 20 and 100 where a higher score indicates better regulation of emotions.

Time frame
Pre- and post-intervention (10 weeks after the initiation of the intervention)

Other outcomes

1

Background information

Parents are asked for concise demographic information about themselves (e.g., age, education) and their child (e.g., age). A total of 8 questions.

Time frame
Pre-intervention

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

PRIMA

Collaborator

Psykologpartners

Collaborator

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