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

Post-Traumatic Stress Disorder Clinical Trial

— TCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516827
• Other study ID #: TCT-001-ULM
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: October 25, 2017
• Start date: February 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2017
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Germany	Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik	Berlin
Germany	Vestische Kinder- und Jugendklinik Datteln	Datteln
Germany	Psychiatrische Klinik Lüneburg	Lüneburg
Germany	Klinik für Psychiatrie und Psychotherapie	Mannheim
Germany	Traumaambulanz LMU	München
Germany	ZfP Südwürttemberg Weissenau	Ravensburg
Germany	Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie	Saarbrücken
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	German Federal Ministry of Eduaction and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)	Symptom severity score	Change from Baseline at 16 weeks (=end of treatment)
Secondary	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 at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Children's Global Assessment Scale (CGAS)	Global impairment	Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)	Post-traumatic stress symptoms	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)	Anxiety	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Children's Depression Inventory (CDI)	Depression	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Child Behavior Checklist (CBCL 4/18)	General Psychopathology	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	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 at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)	Trauma-related Cognitions (Child)	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)	Trauma-related cognitions (Parent)	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Posttraumatic Diagnostic Scale (PDS)	Parental symptoms: PTSD	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Beck Depression Inventory (BDI-II)	Parental Symptoms: Depression	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in State-Trait-Anxiety-Inventory (STAI)	Parental symptoms: Anxiety	Change from Baseline at 8 weeks (=mid-treatment)
Secondary	Change from Baseline in Children's Global Assessment Scale (CGAS)	Global impairment	Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Children's Global Assessment Scale (CGAS)	Global impairment	Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)		Change rom Baseline at 6 months post-treatment
Secondary	Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)		Change from baseline at 12 months post-treatment
Secondary	Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in Children's Depression Inventory (CDI)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Children's Depression Inventory (CDI)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Children's Depression Inventory (CDI)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in Child Behavior Checklist (CBCL 4/18)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Child Behavior Checklist (CBCL 4/18)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Child Behavior Checklist (CBCL 4/18)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in Posttraumatic Diagnostic Scale (PDS)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Posttraumatic Diagnostic Scale (PDS)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Posttraumatic Diagnostic Scale (PDS)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in Beck Depression Inventory (BDI-II)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in Beck Depression Inventory (BDI-II)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in Beck Depression Inventory (BDI-II)		Change from Baseline at 12 months post-treatment
Secondary	Change from Baseline in State-Trait-Anxiety-Inventory (STAI)		Change from Baseline at 16 weeks (=end of treatment)
Secondary	Change from Baseline in State-Trait-Anxiety-Inventory (STAI)		Change from Baseline at 6 months post-treatment
Secondary	Change from Baseline in State-Trait-Anxiety-Inventory (STAI)		Change from Baseline at 12 months post-treatment
Secondary	Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)	Symptom severity score	Change from Baseline at 6 monts post-treatment
Secondary	Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)	Symptom severity score	Change from baseline at 12 months post-treatment