Status:
COMPLETED
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
7-16 years
Phase:
NA
Brief Summary
This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino \& Deblinger (2006) with a wait-list con...
Detailed Description
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de
Eligibility Criteria
Inclusion
- Age 7-16 years
- Exposure to a traumatic event (index trauma) after the age of 3 years, at least 3 months before assessment
- ≥35 points on the Clinician -Administered PTSD Scale for Children and Adolescents (CAPS-CA) total symptom severity score and at least one symptom per PTSD cluster related to the index trauma according to DSM IV diagnostic criteria
- PTSD should be the main mental health problem, patients with co-morbid mental disorders are included
- No major brain injury of the child due to the traumatic event (Glasgow Coma Scale \<9 points at primary medical examination)
- Co-operation of at least one non-offending primary caregiver (improves treatment outcome)
- Living within reasonable distance (max 1 hour of travel) to the treatment center to allow treatment on a weekly basis (feasibility)
Exclusion
- Psychosis
- Acute suicidality
- Psychopharmacological medication started or changed up to 6 weeks before first assessment
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT01516827
Start Date
February 1 2012
End Date
June 1 2016
Last Update
October 27 2017
Active Locations (8)
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1
Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
Berlin, Germany, 13407
2
Vestische Kinder- und Jugendklinik Datteln
Datteln, Germany, 45711
3
Psychiatrische Klinik Lüneburg
Lüneburg, Germany, 21339
4
Klinik für Psychiatrie und Psychotherapie
Mannheim, Germany, 68072