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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2011

Last Updated Date

January 19, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01516827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 7-14 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Post-Traumatic Stress Disorder

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: TF-CBT
Intervention: Behavioral: Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT)
No Intervention: Wait-list

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

January 2015

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lutz Goldbeck, Prof.

TCT.KJP@uniklinik-ulm.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01516827

Other Study ID Numbers ^ICMJE

TCT-001-ULM

Has Data Monitoring Committee

Yes

Responsible Party

Lutz Goldbeck, University of Ulm

Study Sponsor ^ICMJE

University of Ulm

Collaborators ^ICMJE

Funding: Federal Ministry of Eduaction and Research

Investigators ^ICMJE

Principal Investigator:

Lutz Goldbeck, Ph.D.

University Ulm

Information Provided By

University of Ulm

Verification Date

January 2012

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

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