Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems
NCT Number: NCT06559813
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Behavior Problem|Disruptive Behavior|Oppositional Defiant Disorder|Conduct Problems|Aggression|Parent-Child Relations
Interventions: BEHAVIORAL: Step-by-step: A cognitive behavioral parent program with role-plays in virtual reality
Sponsor: Karolinska Institutet
Collaborators: PRIMA|Psykologpartners
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2024-11-30

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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), 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., 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, 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., 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, 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., Pre- and post-intervention (10 weeks after the initiation of the intervention)|Parent: Mean change in parent-ratings of family warmth, Family warmth is measured with 5 questions from the Family Check-Up Caregiver Assessment Scale. These are scored on a 5-point scale (1 to 5). Total maximum score ranges between 5 and 25. A higher score indicates a more positive relation., Pre- and post-intervention (10 weeks after the initiation of the intervention)|Parent: Mean change in parent-ratings of family conflicts, Family conflicts are measured with 3 questions from the Family Check-Up Caregiver Assessment Scale. These are scored on a 7-point scale (0 to 6). Total maximum score ranges between 0 and 18. A higher score indicates larger degree of conflicts., Pre- and post-intervention (10 weeks after the initiation of the intervention)|Parent: Mean change in parent-ratings of parental satisfaction with the week, Three questions scored 0 to 10 about parents' satisfaction with the week, with how they have been able to support their child and manage conflicts. Total maximum score ranges between 0-30, with a higher score indicating higher satisfaction., From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.|Parent: Parental experiences of each session, Four questions after each session about how the parent experienced the session and exercises. Rated on a scale 0-10, with a maximum total score ranging between 0 and 40. A higher score indicates greater satisfaction with the session., From baseline to post-intervention (during 6-10 weeks). Completed once a week at each session.|Parent: Closing questions about the intervention, Closing questions to parents about satisfaction, relevance, and usefulness of the intervention. Parents respond to six questions rated on a scale 0-10, with a maximum total score ranging between 0 and 60. A higher score indicates greater satisfaction., Post-intervention (measured 6 to 10 weeks after the initiation of the intervention)|Use of the parent program: number of sessions, homework tasks, exercises, A summary of the mean number of sessions, homework tasks and exercises completed during the program., From pre- to post-intervention (10 weeks after the initiation of the intervention)|Use of the parent program: drop out rate, The drop out from the program (number of participants)., From pre- to post-intervention (10 weeks after the initiation of the intervention)|Clinicians: Clinician perception of implementation, Clinicians will respond to two questions rated 0-10 after each session about their implementation of the treatment session, higher scores indicating higher satisfaction (maximum weekly mean score is 20)., From pre- to post-intervention (during 6-10 weeks).|Parent, clinician: Experiences of the parenting program explored through separate, individual qualitative interviews with parent and clinician, Qualitative interviews will explore parent's and clinician's experiences of the treatment. We will investigate satisfaction, feasibility, acceptability, and relevance of the program. The interviews with parents are partly based on an established scale, modified for this purpose, and self-constructed questions. Interviews with clinicians are based on self-constructed oral questions examining acceptability, relevance, feasibility and satisfaction., Interviews are conducted after the program is completed, 10 weeks after the initiation of each program
Other Outcome Measures: 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., Pre-intervention