Back to resultsEffectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma) (TCT)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Children and Adolescents, Post-Traumatic Stress Disorder in Children and Adolescents
Eligibility 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
Sites / Locations
- Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
- Vestische Kinder- und Jugendklinik Datteln
- Psychiatrische Klinik Lüneburg
- Klinik für Psychiatrie und Psychotherapie
- Traumaambulanz LMU
- ZfP Südwürttemberg Weissenau
- Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
- Universitätsklinikum Ulm
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TF-CBT
Wait-list
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Secondary Outcome Measures
Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
change in co-morbid psychiatric disorders
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Post-traumatic stress symptoms
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Anxiety
Change from Baseline in Children's Depression Inventory (CDI)
Depression
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
General Psychopathology
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Quality of Life
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Trauma-related Cognitions (Child)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Trauma-related cognitions (Parent)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Parental symptoms: PTSD
Change from Baseline in Beck Depression Inventory (BDI-II)
Parental Symptoms: Depression
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Parental symptoms: Anxiety
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Change from Baseline in Children's Depression Inventory (CDI)
Change from Baseline in Children's Depression Inventory (CDI)
Change from Baseline in Children's Depression Inventory (CDI)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Change from Baseline in Beck Depression Inventory (BDI-II)
Change from Baseline in Beck Depression Inventory (BDI-II)
Change from Baseline in Beck Depression Inventory (BDI-II)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Full Information
NCT ID
NCT01516827
First Posted
December 13, 2011
Last Updated
October 25, 2017
Sponsor
University of Ulm
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01516827
Brief Title
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)
Acronym
TCT
Official Title
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Children and Adolescents, Post-Traumatic Stress Disorder in Children and Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TF-CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Description
Symptom severity score
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Secondary Outcome Measure Information:
Title
Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
Description
change in co-morbid psychiatric disorders
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in Children's Global Assessment Scale (CGAS)
Description
Global impairment
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Description
Post-traumatic stress symptoms
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Description
Anxiety
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Children's Depression Inventory (CDI)
Description
Depression
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Description
General Psychopathology
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Description
Quality of Life
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Description
Trauma-related Cognitions (Child)
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Description
Trauma-related cognitions (Parent)
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Description
Parental symptoms: PTSD
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Beck Depression Inventory (BDI-II)
Description
Parental Symptoms: Depression
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Description
Parental symptoms: Anxiety
Time Frame
Change from Baseline at 8 weeks (=mid-treatment)
Title
Change from Baseline in Children's Global Assessment Scale (CGAS)
Description
Global impairment
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in Children's Global Assessment Scale (CGAS)
Description
Global impairment
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time Frame
Change rom Baseline at 6 months post-treatment
Title
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time Frame
Change from baseline at 12 months post-treatment
Title
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)
Title
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
Title
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
Title
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in Children's Depression Inventory (CDI)
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time Frame
Change from Baseline at 12 months post-treatment
Title
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)
Title
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
Title
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
Title
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in Beck Depression Inventory (BDI-II)
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame
Change from Baseline at 16 weeks (=end of treatment)
Title
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame
Change from Baseline at 6 months post-treatment
Title
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time Frame
Change from Baseline at 12 months post-treatment
Title
Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Description
Symptom severity score
Time Frame
Change from Baseline at 6 monts post-treatment
Title
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Description
Symptom severity score
Time Frame
Change from baseline at 12 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lutz Goldbeck, Ph.D.
Organizational Affiliation
University Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
City
Berlin
ZIP/Postal Code
13407
Country
Germany
Facility Name
Vestische Kinder- und Jugendklinik Datteln
City
Datteln
ZIP/Postal Code
45711
Country
Germany
Facility Name
Psychiatrische Klinik Lüneburg
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie
City
Mannheim
ZIP/Postal Code
68072
Country
Germany
Facility Name
Traumaambulanz LMU
City
München
ZIP/Postal Code
80802
Country
Germany
Facility Name
ZfP Südwürttemberg Weissenau
City
Ravensburg
ZIP/Postal Code
88214
Country
Germany
Facility Name
Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
City
Saarbrücken
ZIP/Postal Code
66119
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33370208
Citation
Tutus D, Pfeiffer E, Plener PL, Rosner R, Bernheim D, Sachser C. The Change in Parental Symptoms and Dysfunctional Cognitions in the Course of Trauma-Focused Cognitive-Behavioral Therapy: Sustainability Until One-Year Post-Treatment. J Child Adolesc Psychopharmacol. 2021 Mar;31(2):129-136. doi: 10.1089/cap.2020.0097. Epub 2020 Dec 23.
Results Reference
derived
PubMed Identifier
31343205
Citation
Lindebo Knutsen M, Sachser C, Holt T, Goldbeck L, Jensen TK. Trajectories and possible predictors of treatment outcome for youth receiving trauma-focused cognitive behavioral therapy. Psychol Trauma. 2020 May;12(4):336-346. doi: 10.1037/tra0000482. Epub 2019 Jul 25.
Results Reference
derived
PubMed Identifier
30570287
Citation
Tutus D, Goldbeck L, Pfeiffer E, Sachser C, Plener PL. Parental dysfunctional posttraumatic cognitions in trauma-focused cognitive behavioral therapy for children and adolescents. Psychol Trauma. 2019 Oct;11(7):722-731. doi: 10.1037/tra0000419. Epub 2018 Dec 20.
Results Reference
derived
PubMed Identifier
27677771
Citation
Sachser C, Keller F, Goldbeck L. Complex PTSD as proposed for ICD-11: validation of a new disorder in children and adolescents and their response to Trauma-Focused Cognitive Behavioral Therapy. J Child Psychol Psychiatry. 2017 Feb;58(2):160-168. doi: 10.1111/jcpp.12640. Epub 2016 Sep 28.
Results Reference
derived
PubMed Identifier
26497391
Citation
Unterhitzenberger J, Eberle-Sejari R, Rassenhofer M, Sukale T, Rosner R, Goldbeck L. Trauma-focused cognitive behavioral therapy with unaccompanied refugee minors: a case series. BMC Psychiatry. 2015 Oct 23;15:260. doi: 10.1186/s12888-015-0645-0.
Results Reference
derived
Learn more about this trial
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)
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