Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents

May 30, 2007 updated by: Brigham Young University

Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers

Context: This is the first multi-site randomized controlled study of the effectiveness of a group treatment for war-exposed adolescents delivered in-country within a public school system.

Objective: To evaluate the effectiveness of a trauma/grief-focused group treatment program in reducing symptoms of posttraumatic stress disorder (PTSD), depression, and traumatic grief in war-exposed Bosnian youths attending 10 secondary schools located in Central Bosnia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design: A randomized controlled trial conducted during the 2000-2001 school year, with 4-month follow-up, compared group treatment to a psychoeducation/skill-based school milieu intervention.

Setting and Participants: Students attending 10 Bosnian secondary schools exposed to severe trauma, traumatic loss, and severe adversity, reporting severe persisting symptoms of PTSD, depression, or traumatic grief, and functional impairment.

Intervention: Students were randomly assigned to either 17-session Trauma and Grief Component Therapy (n=71), or a school milieu intervention (n=73), both conducted by trained school counselors.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

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

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Significant trauma exposure before, during, or after the war (e.g., serious physical injury, life threat, witnessing death or serious injury, traumatic bereavement);
  • Significant current distress, especially severe persisting symptoms of PTSD, depression, or traumatic grief;
  • Significant functional impairment in family or peer relationships and school performance

Exclusion Criteria:

  • Acute risk status (e.g., suicidal plans and intent)
  • Psychosis
  • Severe substance abuse (severe enough to interfere with engagement in treatment).

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UCLA PTSD Reaction Index
Time Frame: Pre-treatment, post-treatment, and at 4-month follow-up
Pre-treatment, post-treatment, and at 4-month follow-up
Depression Self-Rating Scale
Time Frame: Pre-treatment, post-treatment, and 4-month follow-up
Pre-treatment, post-treatment, and 4-month follow-up
UCLA Grief Scale
Time Frame: Pre-treatment, post-treatment
Pre-treatment, post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive Distortions Scale
Time Frame: Pre-treatment and post-treatment
Pre-treatment and post-treatment
War Exposure Index
Time Frame: Pre-treatment (screening survey)
Pre-treatment (screening survey)
Post-War Adversities Scale
Time Frame: Pre-treatment (screening survey)
Pre-treatment (screening survey)
Trauma Reminder Screening Scale
Time Frame: Pre-treatment (screening survey)
Pre-treatment (screening survey)
Loss Reminder Screening Scale
Time Frame: Pre-treatment (screening survey)
Pre-treatment (screening survey)
Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales)
Time Frame: Pre- and post-treatment
Pre- and post-treatment

Collaborators and Investigators

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

Sponsor

Brigham Young University

Collaborators

UNICEF

Investigators

  • Principal Investigator: Christopher M Layne, Ph.D., Brigham Young University, Provo, Utah, USA

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

September 1, 2000

Study Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

May 30, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (Estimate)

May 31, 2007

Study Record Updates

Last Update Posted (Estimate)

May 31, 2007

Last Update Submitted That Met QC Criteria

May 30, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-261 ASB

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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