Status:
UNKNOWN
CBITS - Treat Trauma in Child Welfare
Lead Sponsor:
University Hospital Ulm
Collaborating Sponsors:
Ruhr University of Bochum
Philipps University Marburg
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
8-16 years
Phase:
NA
Brief Summary
The goal of this randomized controlled trial is to evaluate the effectiveness of the trauma-focused group intervention CBITS compared with enhanced treatment as usual (TAU+) in child welfare programs ...
Detailed Description
The study objectives are 1. Evaluate the effectiveness of CBITS compared to TAU+ regarding PTSS symptom reduction (primary outcome), anxiety, depression, quality of life and functional level, and con...
Eligibility Criteria
Inclusion
- Age 8-16 years, because this age range reflects the age range in the CBITS evaluation studies, and this age range is specified in the CBITS manual and toolkit).
- Having experienced at least one traumatic event (based on DSM-5 or ICD-10/ICD-11 criteria) as CBITS is designed for children and adolescents with a trauma history.
- At least moderate PTSS (at least 21 points on the CATS-2) as this is recommended in the intervention manual. Participants don't have to fulfill PTSD criteria as the manual does not name this a pre-condition for participation. Additionally, there is large evidence that also youth with subthreshold PTSS show high functional impairment, but respond very well to trauma-focused interventions.
- Being currently cared for by a child welfare program (safe and stable living conditions), planned further stay in the program for at least 12 months in order to complete the CBITS intervention and 10-month follow-up.
- Willingness and informed assent/consent of the participant as well as informed consent of the caregiver/legal guardian to participate in the study (sufficient motivation for group intervention and compliance with the study design).
Exclusion
- Current psychosis for safety reasons and in because in this case another intervention another intervention has priority (same explanation for 2-4).
- severe harm to self or others
- severe substance disorder
- acute suicidality
- Severe mental retardation as there is a certain necessity of sufficient cognitive abilities to benefit from CBITS, to recall trauma memories and to create a trauma narrative.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06038357
Start Date
November 1 2023
End Date
October 30 2025
Last Update
September 14 2023
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