Clinical trial NCT01516827: Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)
Official title: Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Children and Adolescents
Post-Traumatic Stress Disorder in Children and Adolescents
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2012-01-25
Enrollment: 159
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
Secondary outcomes:
measure: Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Children's Global Assessment Scale (CGAS)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Children's Depression Inventory (CDI)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Child Behavior Checklist (CBCL 4/18)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Beck Depression Inventory (BDI-II)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
timeFrame: Change from Baseline at 8 weeks (=mid-treatment)
measure: Change from Baseline in Children's Global Assessment Scale (CGAS)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Children's Global Assessment Scale (CGAS)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
timeFrame: Change rom Baseline at 6 months post-treatment
measure: Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
timeFrame: Change from baseline at 12 months post-treatment
measure: Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in Children's Depression Inventory (CDI)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Children's Depression Inventory (CDI)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Children's Depression Inventory (CDI)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in Child Behavior Checklist (CBCL 4/18)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Child Behavior Checklist (CBCL 4/18)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Child Behavior Checklist (CBCL 4/18)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in Beck Depression Inventory (BDI-II)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in Beck Depression Inventory (BDI-II)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in Beck Depression Inventory (BDI-II)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
timeFrame: Change from Baseline at 16 weeks (=end of treatment)
measure: Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
timeFrame: Change from Baseline at 6 months post-treatment
measure: Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
timeFrame: Change from Baseline at 12 months post-treatment
measure: Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
timeFrame: Change from Baseline at 6 monts post-treatment
measure: Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
timeFrame: Change from baseline at 12 months post-treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
city: Datteln
country: Germany
facility: Vestische Kinder- und Jugendklinik Datteln
city: Lüneburg
country: Germany
facility: Psychiatrische Klinik Lüneburg
city: Mannheim
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie
city: München
country: Germany
facility: Traumaambulanz LMU
city: Ravensburg
country: Germany
facility: ZfP Südwürttemberg Weissenau
city: Saarbrücken
country: Germany
facility: Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: University Ulm
name: Lutz Goldbeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.