Status:
COMPLETED
The Norwegian Stepped-Care TF-CBT Study
Lead Sponsor:
Norwegian Center for Violence and Traumatic Stress Studies
Collaborating Sponsors:
University of South Florida
Conditions:
Post Traumatic Stress Disorder (PTSD)
Depressive Symptoms
Eligibility:
All Genders
7-12 years
Phase:
NA
Brief Summary
Every day, a significant number of children and young people in Norway experience violence, abuse, or other potentially traumatizing events. These children are at risk of developing serious health pro...
Detailed Description
Stepped-Care Trauma-Focused Behavioral Cognitive Therapy (SC-TF-CBT) is a semi home-based treatment for children at risk of developing PTSD, where the child's caregiver takes on the role as helper und...
Eligibility Criteria
Inclusion
- Age 7-12
- Exposure to at least one episode of violence or other potentially traumatizing event
- At least 3 years old at time of trauma
- Minimum 5 symptoms of PTSS (i.e., a frequency score of 2 or 3 on the CATS) of which at least 1 symptom is reexperiencing and 1 symptom is avoidance
- The therapist must talk to the child alone to make sure that the child is safe at home (see exclusion criteria)
- At least one month has passed since the last traumatic event.
- In addition:
- A. If two or more siblings fulfill the inclusion criteria, only the youngest should be included in the study
Exclusion
- Suspicions of psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions.
- Not fluent in Norwegian and needs interpreter to complete treatment
- The caregiver who would be treatment participant was the perpetrator, or perpetrator still living at home
- Parent has had substance use disorder (SUD) within the past 3 months.
- Child or caregiver is suicidal
- If child is taking psychotropic medication regimen must be stable for 4 weeks. However, for stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks.
- Child is currently receiving an other type of trauma treatment
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04073862
Start Date
May 13 2019
End Date
August 31 2022
Last Update
February 8 2023
Active Locations (1)
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1
Norwegian Center for Violence and Traumatic Stress Studies
Oslo, Norway, 0484