Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.

April 22, 2015 updated by: Tine K. Jensen, Norwegian Center for Violence and Traumatic Stress Studies

Trauma-focused Cognitive-behavioural Therapy for Children: A Study of Process and Outcome.

The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children experiencing traumas, such as sexual abuse, physical abuse, domestic violence, serious accidents, or natural disasters, may develop severe health problems.

This study will examine the short and long-term effects of trauma-focused cognitive-behavioural therapy on children exposed to serious trauma, and moderating factors of treatment outcome.

The study will use a random control design, and will be implemented in regular clinical practice in Norway.

More knowledge within this field is important for practitioners as well as policy makers in planning interventions and therapy for children and their caregivers.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Norwegian Center for Violence and Traumatic Stress Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children between the age of 10-18
  • referred to a guidance clinic
  • who have experienced trauma
  • present with PTSD reactions
  • participants and the primary caretaker must be able to speak Norwegian.

Exclusion Criteria:

  • Severe psychosis
  • Severe mental retardation.
  • The youth must not have had severe conduct disorders previous to the trauma experience

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT)
Other: TF-CBT
TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
Active Comparator: 2
Participants will receive sessions of treatment as usual (TAU)
Other: Treatment as Usual (TAU)
Participants will receive regular therapy as is usually practiced in clinics
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD
Time Frame: Before session, middle, end, one year follow-up, 18 month follow-up
Before session, middle, end, one year follow-up, 18 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent distress
Time Frame: Before session, middle, end, one year follow-up, 18 month follow-up
Before session, middle, end, one year follow-up, 18 month follow-up
Therapeutic alliance
Time Frame: After 1st. and 6th. session
After 1st. and 6th. session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Collaborators

Norway: Directorate for Health and Social Affairs

Investigators

  • Principal Investigator: Tine K Jensen, PhD, Norwegian Centre for Violence and Traumatic Stress Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s-07442a(REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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