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

NCT06559800 | Not Yet Recruiting

• 1 other identifier: 2024-00813-01 - Children
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Child Behavior Problem; Disruptive Behavior; Oppositional Defiant Disorder; Conduct Problems; Aggression; Anger

Keywords

Disruptive behavior; Child behavior problems; Cognitive behavior therapy; Virtual reality

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (18)

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

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

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

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

• Parent: Mean change from baseline in parent-ratings of emotion regulation on the Difficulties in Emotion Regulation Scale (brief version)

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

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

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

• Parent: Mean change in parent-ratings of family warmth

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

Other Outcomes (2)

• Background information - parent

  Pre-intervention

• Background information - child

  Pre-intervention

Study Arms (1)

Cognitive behavior therapy for children and youth with role-plays in virtual reality

EXPERIMENTAL

Child/youth cognitive-behavioral program with up to 10 individual, face-to-face, weekly sessions

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

Interventions

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.

Cognitive behavior therapy for children and youth with role-plays in virtual reality

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• PRIMA: collaborator
• Psykologpartners: collaborator

Related Publications (1)

• Alsem SC, van Dijk A, Verhulp EE, Dekkers TJ, De Castro BO. Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. Child Dev. 2023 Nov-Dec;94(6):e344-e361. doi: 10.1111/cdev.13966. Epub 2023 Jul 17.

  PMID: 37459452 BACKGROUND

MeSH Terms

Conditions

Problem Behavior; Oppositional Defiant Disorder; Aggression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Social Behavior

Study Officials

• Pia Enebrink, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia Enebrink, PhD

CONTACT

+46852487738; pia.enebrink@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: August 19, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 30, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share