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

University of Ulm

Status: Completed

Conditions: Post-Traumatic Stress Disorder

Treatments: Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01516827

TCT-001-ULM

Details and patient eligibility

About

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.

Full description

Complete study protocol (in German) available from the PI [e-mail]

Enrollment: 159 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 2 patient groups

TF-CBT

Experimental group

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.

Treatment:

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

Wait-list

No Intervention group

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).