Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)

Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder

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 condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years, at least three months ago, and developed Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of patients and caregivers and to explore moderators and mediators of treatment response. The trial will contribute to implement an evidence-based treatment for traumatized children across a variety of healthcare settings in Germany. The novel aspect is to evaluate the effectiveness of TF-CBT with a broad range of traumatized "real-world" patients in the context of the German mental healthcare system.

Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de

Inclusion Criteria:

• 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 Criteria:

• Psychosis
• Acute suicidality
• Psychopharmacological medication started or changed up to 6 weeks before first assessment