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

October 25, 2017 updated by: Lutz Goldbeck, University of Ulm

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 7-16 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13407
        • Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
      • Datteln, Germany, 45711
        • Vestische Kinder- und Jugendklinik Datteln
      • Lüneburg, Germany, 21339
        • Psychiatrische Klinik Lüneburg
      • Mannheim, Germany, 68072
        • Klinik für Psychiatrie und Psychotherapie
      • München, Germany, 80802
        • Traumaambulanz LMU
      • Ravensburg, Germany, 88214
        • ZfP Südwürttemberg Weissenau
      • Saarbrücken, Germany, 66119
        • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at 16 weeks (=end of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Global impairment
Change from Baseline at 16 weeks (=end of treatment)
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
Change from Baseline at 8 weeks (=mid-treatment)
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
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
Depression
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
General Psychopathology
Change from Baseline at 8 weeks (=mid-treatment)
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
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
Trauma-related Cognitions (Child)
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
Trauma-related cognitions (Parent)
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
Parental symptoms: PTSD
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
Parental Symptoms: Depression
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame: Change from Baseline at 8 weeks (=mid-treatment)
Parental symptoms: Anxiety
Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Time Frame: Change from Baseline at 6 months post-treatment
Global impairment
Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Global Assessment Scale (CGAS)
Time Frame: Change from Baseline at 12 months post-treatment
Global impairment
Change from Baseline at 12 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time Frame: Change rom Baseline at 6 months post-treatment
Change rom Baseline at 6 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time Frame: Change from baseline at 12 months post-treatment
Change from baseline at 12 months post-treatment
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)
Change from Baseline at 16 weeks (=end of treatment)
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
Change from Baseline at 6 months post-treatment
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
Change from Baseline at 12 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
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)
Change from Baseline at 16 weeks (=end of treatment)
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
Change from Baseline at 6 months post-treatment
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
Change from Baseline at 12 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame: Change from Baseline at 6 months post-treatment
Change from Baseline at 6 months post-treatment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame: Change from Baseline at 12 months post-treatment
Change from Baseline at 12 months post-treatment
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
Change from Baseline at 6 monts post-treatment
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
Change from baseline at 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulm

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lutz Goldbeck, Ph.D., University Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCT-001-ULM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings