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Completed

NCT Number: NCT01516827

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik, Berlin, Germany

Loading trial locations.

About this study

Complete study protocol (in German) available from the PI [email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: TCT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2012
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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