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

Recruiting · NCT06902649 · Interventional (participants receive a specific treatment) · Lead sponsor: Karolinska Institutet

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ADHD

Interventions studied

"YourSkills" for children/youthInternet-based parenting supportIntervention/support as usual and prolonged use of internet-based parenting supportStep-by-step parent support

What this trial is about

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 take part

Age range

8 Years to 16 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 it is running

1 location listed.

Karolinska Institutet - Solna, Sweden

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →