Step-by-Step: Evaluation of a Stepped Care Model
Launched by KAROLINSKA INSTITUTET · Mar 27, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called "Step-by-Step," is looking to find out how well a new approach helps children aged 8 to 16 who struggle with defiant or aggressive behaviors, like anger and disobedience. The study uses a "stepped care model," which means families start with a simple online parenting support program. If more help is needed, they can choose from additional options, such as virtual reality-assisted therapy for the child or parent, or traditional support through their local clinic, along with continued access to the online program.
To be eligible for the trial, children must show certain signs of defiant behavior, like being easily angered or refusing to follow rules. It's important that the child is stable on any prescribed medications during the study. Families must also be able to read and understand materials in Swedish. However, children with certain severe mental health issues or those already receiving other treatments for similar problems won't be able to participate. This study is not yet recruiting participants, but it offers a promising approach to support families dealing with these challenging behaviors.
Gender
ALL
Eligibility 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
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Solna, , Sweden
Patients applied
Trial Officials
Pia Enebrink, PhD
Principal Investigator
Karolinska Institutet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported