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

NCT01516827 | Completed DMC

• 1 other identifier: TCT-001-ULM
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 8

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD; Children and Adolescents; Post-Traumatic Stress Disorder in Children and Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (46)

• Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)

  Change from Baseline at 16 weeks (=end of treatment)

• Change from Baseline in Children's Global Assessment Scale (CGAS)

  Change from Baseline at 16 weeks (=end of treatment)

• Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)

  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)

  Change from Baseline at 8 weeks (=mid-treatment)

• Change from Baseline in Children's Depression Inventory (CDI)

  Change from Baseline at 8 weeks (=mid-treatment)

Study Arms (2)

TF-CBT

EXPERIMENTAL

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)

Wait-list

NO INTERVENTION

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).

Interventions

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) BEHAVIORAL

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.

TF-CBT

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Psychosis
• Acute suicidality
• Psychopharmacological medication started or changed up to 6 weeks before first assessment

Sponsors & Collaborators

• University of Ulm: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (8)

Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik

Berlin, 13407, Germany

Location

Vestische Kinder- und Jugendklinik Datteln

Datteln, 45711, Germany

Location

Psychiatrische Klinik Lüneburg

Lüneburg, 21339, Germany

Location

Klinik für Psychiatrie und Psychotherapie

Mannheim, 68072, Germany

Location

Traumaambulanz LMU

München, 80802, Germany

Location

ZfP Südwürttemberg Weissenau

Ravensburg, 88214, Germany

Location

Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie

Saarbrücken, 66119, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Related Publications (5)

• 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.

  PMID: 33370208 DERIVED

• 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.

  PMID: 31343205 DERIVED

• 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.

  PMID: 30570287 DERIVED

• 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.

  PMID: 27677771 DERIVED

• 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.

  PMID: 26497391 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Lutz Goldbeck, Ph.D.

  University Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Section for Psychotherapy Re-search and Behavioural Medicine

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

DE (8)