RecruitingNot Applicable

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

Sweden210 participantsStarted 2025-04-02

Plain-language 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.

Who can participate

Age range8 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).

Timeframe: Pre-, mid- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.

Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria

Timeframe: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.

Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children

Timeframe: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)

Trial details

NCT IDNCT06902649

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Pia Enebrink, PhD

+46852487738 pia.enebrink@ki.se

View on ClinicalTrials.gov More Child Behavior Problem trials