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

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ClinicalTrials.gov Identifier: NCT01516827
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
German Federal Ministry of Eduaction and Research
Information provided by (Responsible Party):
Lutz Goldbeck, 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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) Not Applicable

Detailed Description:
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder
Study Start Date : February 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.

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 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.
No Intervention: Wait-list
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).



Primary Outcome Measures :
  1. 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) ]
    Symptom severity score


Secondary Outcome Measures :
  1. 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) ]
    change in co-morbid psychiatric disorders

  2. Change from Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
    Global impairment

  3. Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Post-traumatic stress symptoms

  4. 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) ]
    Anxiety

  5. Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Depression

  6. Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    General Psychopathology

  7. 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) ]
    Quality of Life

  8. Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Trauma-related Cognitions (Child)

  9. Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Trauma-related cognitions (Parent)

  10. Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Parental symptoms: PTSD

  11. Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Parental Symptoms: Depression

  12. Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 8 weeks (=mid-treatment) ]
    Parental symptoms: Anxiety

  13. Change from Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline at 6 months post-treatment ]
    Global impairment

  14. Change from Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline at 12 months post-treatment ]
    Global impairment

  15. Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  16. Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change rom Baseline at 6 months post-treatment ]
  17. Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report) [ Time Frame: Change from baseline at 12 months post-treatment ]
  18. 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) ]
  19. 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 ]
  20. 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 ]
  21. Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  22. Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  23. Change from Baseline in Children's Depression Inventory (CDI) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  24. Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  25. Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  26. Change from Baseline in Child Behavior Checklist (CBCL 4/18) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  27. 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) ]
  28. 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 ]
  29. 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 ]
  30. Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  31. Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  32. Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  33. Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  34. Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  35. Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  36. Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  37. Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  38. Change from Baseline in Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  39. Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  40. Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  41. Change from Baseline in Beck Depression Inventory (BDI-II) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  42. Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 16 weeks (=end of treatment) ]
  43. Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 6 months post-treatment ]
  44. Change from Baseline in State-Trait-Anxiety-Inventory (STAI) [ Time Frame: Change from Baseline at 12 months post-treatment ]
  45. Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) [ Time Frame: Change from Baseline at 6 monts post-treatment ]
    Symptom severity score

  46. Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) [ Time Frame: Change from baseline at 12 months post-treatment ]
    Symptom severity score



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516827


Locations
Germany
Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
Berlin, Germany, 13407
Vestische Kinder- und Jugendklinik Datteln
Datteln, Germany, 45711
Psychiatrische Klinik Lüneburg
Lüneburg, Germany, 21339
Klinik für Psychiatrie und Psychotherapie
Mannheim, Germany, 68072
Traumaambulanz LMU
München, Germany, 80802
ZfP Südwürttemberg Weissenau
Ravensburg, Germany, 88214
Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
Saarbrücken, Germany, 66119
Universitätsklinikum Ulm
Ulm, Germany, 89075
Sponsors and Collaborators
University of Ulm
German Federal Ministry of Eduaction and Research
Investigators
Principal Investigator: Lutz Goldbeck, Ph.D. University Ulm

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lutz Goldbeck, Head of Section for Psychotherapy Re-search and Behavioural Medicine, University of Ulm
ClinicalTrials.gov Identifier: NCT01516827     History of Changes
Other Study ID Numbers: TCT-001-ULM
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Lutz Goldbeck, University of Ulm:
PTSD
Children and Adolescents
Post-Traumatic Stress Disorder in Children and Adolescents

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders