Step-by-Step: Stepped care for children with defiant or aggressive behavior
Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents
This project tests a stepped care program for families of 8–16-year-olds with defiant or aggressive behavior, starting with an online parenting course and adding virtual-reality–assisted CBT for the child or parent or usual clinic care if more help is needed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Solna) |
| Trial ID | NCT06902649 on ClinicalTrials.gov |
What this trial studies
The program begins with a brief internet-based parenting support course ('Step 1') for families of children aged 8–16 who show defiant or aggressive behaviors. Families whose problems persist are offered Step 2, which may be CBT delivered with virtual-reality support for either the parent or the child, or standard clinic-based interventions plus continued online support, with the option to later choose CBT-VR. Outcomes include changes in child aggressive and oppositional behaviors, treatment engagement, and feasibility of using a stepped approach. The project is coordinated by Karolinska Institutet and Region Stockholm and requires participants to engage with materials in Swedish.
Who should consider this trial
Good fit: Ideal candidates are families in Sweden with children aged 8–16 who have trouble controlling anger or meet criteria for oppositional defiant disorder or aggressive conduct, and whose parents can read Swedish.
Not a fit: Children with severe depression, active suicidality, bipolar disorder, psychosis, severe autism (level 2–3), intellectual disability, ongoing criminal behavior requiring other interventions, or those already in concurrent psychological treatment for the same condition are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the model could reduce children's aggressive and defiant behaviors by matching families to the least intensive effective intervention and offering VR-enhanced CBT when needed.
How similar studies have performed: Parenting programs and CBT have established evidence for reducing child behavior problems, while virtual-reality–assisted CBT is a newer approach with promising but limited clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Solna
- Karolinska Institutet — Solna, Sweden (Recruiting)
Study contacts
- Principal investigator: Pia Enebrink, PhD — Karolinska Institutet
- Study coordinator: Pia Enebrink, PhD
- Email: pia.enebrink@ki.se
- Phone: +46852487738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.