Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorKarolinska Institutet

About this trial

The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior (e.g., enhanced anger or aggressive behavior) when evaluated in Sweden for children/youth 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 child/youth CBT-VR-program? * What is the level of child/youth engagement in the CBT-VR program? * What are the experiences of parents, children/youth 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Child/youth aged between 10-16 years with increased levels of anger or disruptive behaviors,

The child's behavior problems is elevated on questions targeting behavioral problems (SDQ conduct problems subscale).

Disqualifiers

Child/youth is below 10 years or above 16 years of age

No increased levels of anger or disruptive behaviors

Child/youth is diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors

Child/youth has epilepsy or migraine

Trial design

Design model

Single group

Treatments tested in this trial

  • YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality

    Behavioral

    A program for children/youth with anger problems or aggressive behaviors based on social learning theory and cognitive behavior therapy (CBT), incorporating virtual reality (VR) when conducting brief role-plays. The program includes similar strategies as other CBT-oriented programs for anger problems, with the addition of VR for practicing skills.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Cognitive behavior therapy for children and youth with role-plays in 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 oppositional defiant disorder subscale of the Disruptive Behavior Disorder scale 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 total scale sum ranges från 0 to a total maximum sum of 24 with a higher score indicating more behavior problems.

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

Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children

The Anger expression scale for children includes 26 questions about anger and anger management and is rated by children on a 4-point Likert scale (from 1 to 4). We use two modified sub-scales: anger expression (score ranges from 17 to 68) and anger control (score ranges from 9 to 36) with higher scores indicating higher levels of anger expression and anger control.

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 has 10 items and evaluates how parents perceive the health and well-being of their child or adolescent. The items are scored on a 5-point scale (1-5). A total maximum sum ranges between 10 and 50, and a higher score indicates 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) assesses mental health through five subscales (peer relationship problems, prosocial behavior, emotional symptoms, hyperactivity/ inattention, conduct problems) and a total difficulties score. 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 where 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 (brief version)

Parents' general emotion regulation ability will be measured with the Difficulties in Emotion Regulation Scale-16. The 16 items are scored on a 5-point scale (1 to 5). The total summary score ranges between 16 and 80, a higher score indicating 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

Parental emotion regulation will be measured with 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, with a higher score indicating better regulation of emotions.

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

Other outcomes

1

Background information - parent

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

Time frame
Pre-intervention
2

Background information - child

Children are asked three demographic questions about themselves (e.g., age).

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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