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

NCT06559813 | Not Yet Recruiting

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

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.

Conditions

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

Keywords

Disruptive Behavior; Child Behavior Problem; Parenting; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (13)

• 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-16

  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 (1)

• Background information

  Pre-intervention

Study Arms (1)

Parent training with cognitive behavior therapy and virtual reality

EXPERIMENTAL

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

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

Interventions

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.

Parent training with cognitive behavior therapy and virtual reality

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

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

  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 25, 2024
• Study Completion: November 30, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08