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

Study Overview
=================
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

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

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TF-CBT<br>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. | Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)<br>* 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.<br>|
| No Intervention: Wait-list<br>Patients in the control condition will be assigned to a wait-list (duration 4 months). During waiting time, clinical services will be provided as needed (excluding TF-CBT). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) | Symptom severity score | Change from Baseline at 16 weeks (=end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL) | change in co-morbid psychiatric disorders | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in Children's Global Assessment Scale (CGAS) | Global impairment | 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 | 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 | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in Children's Depression Inventory (CDI) | Depression | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in Child Behavior Checklist (CBCL 4/18) | General Psychopathology | 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 | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) | Trauma-related Cognitions (Child) | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) | Trauma-related cognitions (Parent) | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in Posttraumatic Diagnostic Scale (PDS) | Parental symptoms: PTSD | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in Beck Depression Inventory (BDI-II) | Parental Symptoms: Depression | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in State-Trait-Anxiety-Inventory (STAI) | Parental symptoms: Anxiety | Change from Baseline at 8 weeks (=mid-treatment) | 
| Change from Baseline in Children's Global Assessment Scale (CGAS) | Global impairment | Change from Baseline at 6 months post-treatment | 
| Change from Baseline in Children's Global Assessment Scale (CGAS) | Global impairment | Change from Baseline at 12 months post-treatment | 
| Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) |  | Change rom Baseline at 6 months post-treatment | 
| 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 Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report) |  | 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) |  | 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) |  | Change from Baseline at 12 months post-treatment | 
| Change from Baseline in Children's Depression Inventory (CDI) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in Children's Depression Inventory (CDI) |  | Change from Baseline at 6 months post-treatment | 
| Change from Baseline in Children's Depression Inventory (CDI) |  | Change from Baseline at 12 months post-treatment | 
| Change from Baseline in Child Behavior Checklist (CBCL 4/18) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in Child Behavior Checklist (CBCL 4/18) |  | Change from Baseline at 6 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 Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report) |  | 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) |  | 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) |  | Change from Baseline at 12 months post-treatment | 
| Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) |  | Change from Baseline at 6 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 The Posttraumatic Cognitions Inventory (PTCI) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) |  | Change from Baseline at 6 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 16 weeks (=end of treatment) | 
| Change from Baseline in Posttraumatic Diagnostic Scale (PDS) |  | Change from Baseline at 6 months post-treatment | 
| Change from Baseline in Posttraumatic Diagnostic Scale (PDS) |  | Change from Baseline at 12 months post-treatment | 
| Change from Baseline in Beck Depression Inventory (BDI-II) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in Beck Depression Inventory (BDI-II) |  | Change from Baseline at 6 months post-treatment | 
| Change from Baseline in Beck Depression Inventory (BDI-II) |  | Change from Baseline at 12 months post-treatment | 
| Change from Baseline in State-Trait-Anxiety-Inventory (STAI) |  | Change from Baseline at 16 weeks (=end of treatment) | 
| Change from Baseline in State-Trait-Anxiety-Inventory (STAI) |  | Change from Baseline at 6 months post-treatment | 
| Change from Baseline in State-Trait-Anxiety-Inventory (STAI) |  | Change from Baseline at 12 months post-treatment | 
| Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) | Symptom severity score | 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 | Change from baseline at 12 months post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Children and Adolescents, Post-Traumatic Stress Disorder in Children and Adolescents