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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German 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: August 25, 2015
Last verified: August 2015
  Purpose

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 Intervention
Post-Traumatic Stress Disorder
Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: December 13, 2011
Last Updated: August 25, 2015
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 01, 2015