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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
159
TF-CBT (see also HThttp://tfcbt.musc.eduTH) is a manualised intervention for traumatized children and adolescents 7 to 16 years old and their parent/caregiver. The primary components are summarized by the acronym PRACTICE: Parenting skills, Psychoeducation, Relaxation, Affect modulation, Cognitive processing, Trauma narrative, In vivo mastery of trauma reminders, Conjoint child-parent session, and Enhancing safety and future development. We will use the manual as provided by Cohen et al. and available in German. The treatment program will comprise 12 sessions with children and parents (partly separated, partly conjoined sessions) of 90 minutes each. The 12 sessions will be distributed over a duration of 16 weeks.
Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
Berlin, Germany
Vestische Kinder- und Jugendklinik Datteln
Datteln, Germany
Psychiatrische Klinik Lüneburg
Lüneburg, Germany
Klinik für Psychiatrie und Psychotherapie
Mannheim, Germany
Traumaambulanz LMU
München, Germany
ZfP Südwürttemberg Weissenau
Ravensburg, Germany
Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
Saarbrücken, Germany
Universitätsklinikum Ulm
Ulm, Germany
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
change in co-morbid psychiatric disorders
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Post-traumatic stress symptoms
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Anxiety
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Depression
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
General Psychopathology
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Quality of Life
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Trauma-related Cognitions (Child)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Trauma-related cognitions (Parent)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Parental symptoms: PTSD
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Parental Symptoms: Depression
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Parental symptoms: Anxiety
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change rom Baseline at 6 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change from baseline at 12 months post-treatment
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time frame: Change from Baseline at 12 months post-treatment
Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Time frame: Change from Baseline at 6 monts post-treatment
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Time frame: Change from baseline at 12 months post-treatment
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