Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)
- Conditions
- Post-Traumatic Stress Disorder
- Interventions
- Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
- Registration Number
- NCT01516827
- Lead Sponsor
- University of Ulm
- 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 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.
- Detailed Description
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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)
- Psychosis
- Acute suicidality
- Psychopharmacological medication started or changed up to 6 weeks before first assessment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TF-CBT Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) 12 Sessions Trauma-focused Cognitive Behavioral Therapy including the child/adolescents and a non-abusive caregiver according to the treatment manual: Cohen JA, Mannarino AP, and Deblinger E (2006) Treating Trauma and Traumatic Grief in Children and Adolenscents. Guilford, N.Y.
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) Change from Baseline at 16 weeks (=end of treatment) Symptom severity score
- Secondary Outcome Measures
Name Time Method Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL) Change from Baseline at 16 weeks (=end of treatment) change in co-morbid psychiatric disorders
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) 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) Change from Baseline at 12 months post-treatment Change from Baseline in Children's Global Assessment Scale (CGAS) Change from Baseline at 12 months post-treatment Global impairment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI) Change from Baseline at 12 months post-treatment Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) Change from baseline at 12 months post-treatment Symptom severity score
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report) Change from Baseline at 12 months post-treatment Change from Baseline in Child Behavior Checklist (CBCL 4/18) Change from Baseline at 12 months post-treatment Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) Change from Baseline at 12 months post-treatment Change from Baseline in Beck Depression Inventory (BDI-II) Change from Baseline at 12 months post-treatment Change from Baseline in Children's Depression Inventory (CDI) Change from Baseline at 12 months post-treatment Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) Change from Baseline at 12 months post-treatment Change from Baseline in Posttraumatic Diagnostic Scale (PDS) Change from Baseline at 12 months post-treatment Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) Change from Baseline at 6 monts post-treatment Symptom severity score
Trial Locations
- Locations (8)
Vestische Kinder- und Jugendklinik Datteln
🇩🇪Datteln, Germany
Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
🇩🇪Berlin, 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