The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.
Families with children aged 8-16 years who have difficulty controlling anger or exhibit defiant or aggressive behavior. The child/adolescent meets 3 of the diagnostic criteria for Oppositional Defiant Disorder or 2 criteria for Conduct Disorder indicating aggressive behavior.
Medication for the child can remain stable.
Parents need to be able to read and engage with materials in Swedish
Families with children younger than 8 years old or who have already turned 17, or who do not exhibit defiant or aggressive behaviors according to the first inclusion criterion.
Children with severe depression, suicidal behavior, bipolar disorder, psychosis, eating disorders, severe autism (level 2 and 3), diagnosed intellectual disability, or ongoing criminal behavior assessed to require interventions other than the study's interventions are excluded.
Children/adolescents with other ongoing psychological treatments for the same condition or assessed by the clinician in need of other interventions
Parents and children with epilepsy or migraines
Parallel
Internet-based parenting support
BehavioralAn internet-based parent training program with 5 active modules and a final summarizing module, based on social learning theory/cognitive behavior therapy. All parents participate in this intervention (Step 1) before being randomized to the other three arms of the stepped care model in the randomized controlled trial (Step 2).
"YourSkills" for children/youth
BehavioralCognitive behavioral therapy for children/youth with role-plays in virtual reality. 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.
Step-by-step parent support
BehavioralA parent training program based on social learning theory and cognitive behavioral therapy (CBT), including some sessions where virtual reality may be used 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 can be used as an additional way to practice skills.
Intervention/support as usual and prolonged use of internet-based parenting support
BehavioralBased on other available support, interventions, courses at the units. Parents have access to the internet-based parenting support provided in Step 1 (the first intervention of the study). After 10 weeks with intervention/support as usual, the parents are asked if they want to participate in the CBT-VR-intervention for children (YourSkills) or for parents (Step-by-Step parent support).
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 from 0 to a total maximum sum of 24 with a higher score indicating more behavior problems.
Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria
The number of Oppositional defiant disorder criteria (between 0-8) and Conduct disorder criteria (aggressive symptoms; between 0-5). Total number ranges between 0-13 criteria.
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). Two modified sub-scales are used: 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.
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.
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, each including 7 items. 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. The proactive parenting behavior-subscale at baseline is used for moderator/predictor analyses.
Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Scale (over-reactivity subscale)
The Parenting Scale has one subscale that measures parental over-reactivity. The 5 items are scored on a 7-point scale (1 to 7) and the total scale sum ranges from 7 to a maximum of 35. A lower score indicates more positive parenting (after reverse coding). The Parenting Scale is included as a mediator of outcome.
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. Warmth is included as a mediator of outcome.
Parent: Background information
Parents are asked for brief demographic information (e.g., parental age, education; child age, gender, attention deficit hyperactivity disorder \[adhd\]-diagnosis). A total of 13 questions. Child age, gender and adhd-diagnosis are used for moderator/predictor analyses.
Parent: Background information about number of limited prosocial emotions (callous-unemotional traits)
Parents are asked about the number of child limited prosocial emotions. A total of 4 items answered yes/no (total sum between 0-4). Used for moderator/predictor analyses.
Parent: Number of participants with oppositional defiant disorder or conduct disorder diagnosis
Oppositional defiant disorder diagnosis or Conduct disorder diagnosis (limited to presence of aggressive symptoms and serious violations of rules). This variable is used as moderator/predictor.
Use of each intervention: number of sessions, homework tasks
A summary of the mean number of sessions and homework tasks completed during each intervention.
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
