Actively Recruiting
Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents
Led by Karolinska Institutet · Updated on 2026-03-06
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a stepped care model for children and adolescents aged 8 to 16 years who exhibit defiant or aggressive behavior problems. The study focuses on families dealing with conditions like oppositional defiant disorder, conduct disorder, and related behavioral challenges. It seeks to understand how different interventions impact children's behavior, emotional wellbeing, and family dynamics, as well as the cost-effectiveness of these treatments. The stepped care model involves two steps. First, all parents receive a 5-week internet-based parenting support program based on cognitive behavioral therapy principles. Families needing further help after this step are randomized into one of three groups: a cognitive behavioral therapy (CBT) program with virtual reality (VR) for parents; a CBT-VR intervention for children/youth involving up to 10 individual weekly face-to-face sessions; or standard interventions and support at the family's clinic alongside continued access to the internet-based program. After this, families may choose to access CBT-VR for parents or children. Participants will be assessed through validated questionnaires completed by parents and children before, during, and after each intervention, including follow-ups six months after the final treatment. Researchers will measure changes in behavioral problems, emotional wellbeing, parenting strategies, family warmth and conflicts, and parental emotion regulation. Qualitative interviews will explore experiences of the interventions. The study will analyze these data to evaluate both immediate and longer-term effects and the overall impact on child behavior and family wellbeing.
CONDITIONS
Brief Title
Step-by-Step: Evaluation of a Stepped Care Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Families with children aged 8 to 16 years showing difficulty controlling anger or defiant/aggressive behavior
- Child meets at least 3 diagnostic criteria for Oppositional Defiant Disorder or 2 criteria for Conduct Disorder related to aggression
- Child's medication must be stable
- Parents must be able to read and engage with study materials in Swedish
You will not qualify if you...
- Children younger than 8 years or older than 16 years
- Children without defiant or aggressive behaviors as defined in inclusion
- Children with severe depression, suicidal behavior, bipolar disorder, psychosis, eating disorders, severe autism (level 2 or 3), intellectual disability, or ongoing criminal behavior requiring other interventions
- Children currently receiving other psychological treatments for the same condition or needing other interventions as assessed by a clinician
- Parents or children who have epilepsy or migraines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening interview
Duration - 5 weeks
Participants begin with a 5-week internet-based parenting support program that includes 5 active modules and a final summarizing module based on social learning theory and cognitive behavior therapy.
Weekly assessments completed by parents and children during the program
Duration - Up to 10 weeks
Participants who choose to continue are randomized to one of three interventions: a cognitive-behavioral therapy (CBT) virtual reality-assisted parenting support program, a CBT virtual reality-assisted child intervention with up to 10 weekly face-to-face sessions, or standard interventions/support at their clinic with continued access to the internet-based parenting support program for 10 weeks.
Weekly face-to-face sessions for CBT-VR interventions; participants in standard intervention have continued online program access and clinic visits as usual
Duration - Variable, depending on participant choice
After completing the standard intervention/support period, families may opt to receive additional CBT-VR interventions for children or parents based on preference.
Additional face-to-face sessions if chosen
Duration - 6 months after final intervention
Participants complete follow-up assessments to evaluate the effects of the interventions on behavioral problems, emotional well-being, parenting strategies, and family dynamics six months after the final intervention.
Scheduled follow-up visits or assessments
Trial Site Locations
Total: 1 location
1
Karolinska Institutet
Solna, Sweden
Actively Recruiting
Research Team
P
Pia Enebrink, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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