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

This study is not yet open for participant recruitment.
Verified January 2012 by University of Ulm
Sponsor:
Collaborator:
Funding: Federal Ministry of Eduaction and Research
Information provided by (Responsible Party):
Lutz Goldbeck, University of Ulm
ClinicalTrials.gov Identifier:
NCT01516827
First received: December 13, 2011
Last updated: January 19, 2012
Last verified: January 2012

December 13, 2011
January 19, 2012
February 2012
July 2014   (final data collection date for primary outcome measure)
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
Symptom severity score
Same as current
Complete list of historical versions of study NCT01516827 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: Yes ]
    change in co-morbid psychiatric disorders
  • Change from Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
    Global impairment
  • Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Post-traumatic stress symptoms
  • Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Anxiety
  • Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Depression
  • Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: Yes ]
    General Psychopathology
  • 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 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Quality of Life
  • Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Trauma-related Cognitions (Child)
  • Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Trauma-related cognitions (Parent)
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Parental symptoms: PTSD
  • Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: Yes ]
    Parental Symptoms: Depression
  • Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ] [ Designated as safety issue: No ]
    Parental symptoms: Anxiety
  • Change from Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
    Global impairment
  • Change from Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
    Global impairment
  • Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
  • Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change rom Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change from baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
  • Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
  • Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
  • Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: Yes ]
  • Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ] [ Designated as safety issue: No ]
  • Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 6 months post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
  • Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) [ Time Frame: Change from Baseline at 6 monts post-treatment ] [ Designated as safety issue: No ]
    Symptom severity score
  • Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) [ Time Frame: Change from baseline at 12 months post-treatment ] [ Designated as safety issue: No ]
    Symptom severity score
Same as current
Not Provided
Not Provided
 
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 7-14 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
Behavioral: Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT)
TF-CBT (see also HThttp://tfcbt.musc.eduTH) is a manualised intervention for traumatized children and adolescents 7 to 14 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 childparent 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.
  • Experimental: TF-CBT
    Intervention: Behavioral: Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT)
  • No Intervention: Wait-list
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
January 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 7-14 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
Both
7 Years to 14 Years
No
Contact: Lutz Goldbeck, Prof. TCT.KJP@uniklinik-ulm.de
Germany
 
NCT01516827
TCT-001-ULM
Yes
Lutz Goldbeck, University of Ulm
University of Ulm
Funding: Federal Ministry of Eduaction and Research
Principal Investigator: Lutz Goldbeck, Ph.D. University Ulm
University of Ulm
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP