Post-Traumatic Stress Disorder
Conditions
Keywords
PTSD, Children and Adolescents, Post-Traumatic Stress Disorder in Children and Adolescents
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
Interventions
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.
Sponsors
German Federal Ministry of Education and Research
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Children's Global Assessment Scale (CGAS) | Change from Baseline at 16 weeks (=end of treatment) | Global impairment |
| Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) | Change from Baseline at 8 weeks (=mid-treatment) | Post-traumatic stress symptoms |
| Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report) | Change from Baseline at 8 weeks (=mid-treatment) | Anxiety |
| Change from Baseline in Children's Depression Inventory (CDI) | Change from Baseline at 8 weeks (=mid-treatment) | Depression |
| Change from Baseline in Child Behavior Checklist (CBCL 4/18) | Change from Baseline at 8 weeks (=mid-treatment) | General Psychopathology |
| Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report) | Change from Baseline at 8 weeks (=mid-treatment) | Quality of Life |
| 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 The Posttraumatic Cognitions Inventory (PTCI) | Change from Baseline at 8 weeks (=mid-treatment) | Trauma-related cognitions (Parent) |
| Change from Baseline in Posttraumatic Diagnostic Scale (PDS) | Change from Baseline at 8 weeks (=mid-treatment) | Parental symptoms: PTSD |
| Change from Baseline in Beck Depression Inventory (BDI-II) | Change from Baseline at 8 weeks (=mid-treatment) | Parental Symptoms: Depression |
| Change from Baseline in State-Trait-Anxiety-Inventory (STAI) | Change from Baseline at 8 weeks (=mid-treatment) | Parental symptoms: Anxiety |
| Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) | Change from Baseline at 6 monts post-treatment | Symptom severity score |
| 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 Child Post Traumatic Cognitions Inventory (CPTCI) | Change from Baseline at 8 weeks (=mid-treatment) | Trauma-related Cognitions (Child) |
Countries
Germany
Outcome results
None listed