RecruitingNot ApplicableNCT06902649

Step-by-Step: Evaluation of a Stepped Care Model

Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents


Sponsor

Karolinska Institutet

Enrollment

210 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 YearsMax Age: 16 Years

Inclusion Criteria3

  • 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

Exclusion Criteria4

  • 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

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Interventions

BEHAVIORALInternet-based parenting support

An 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).

BEHAVIORAL"YourSkills" for children/youth

Cognitive 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.

BEHAVIORALStep-by-step parent support

A 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.

BEHAVIORALIntervention/support as usual and prolonged use of internet-based parenting support

Based 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).


Locations(1)

Karolinska Institutet

Solna, Sweden

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NCT06902649


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