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

Sponsors and Collaborators:	Brigham Young University UNICEF
Information provided by:	Brigham Young University
ClinicalTrials.gov Identifier:	NCT00480480

Purpose

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.

Condition	Intervention
Posttraumatic Stress Disorder Depression Grief (Traumatic Grief and Existential Grief)	Behavioral: Trauma and Grief Component Therapy for Adolescents (Group Version)

MedlinePlus related topics: Depression Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers

Further study details as provided by Brigham Young University:

Primary Outcome Measures:

UCLA PTSD Reaction Index [ Time Frame: 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 ]
UCLA Grief Scale [ Time Frame: Pre-treatment, post-treatment ]

Secondary Outcome Measures:

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

Enrollment:	144
Study Start Date:	September 2000
Study Completion Date:	October 2001

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.

Eligibility

Ages Eligible for Study:	14 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480480

Sponsors and Collaborators

Brigham Young University

UNICEF

Investigators

Principal Investigator:

Christopher M Layne, Ph.D.

Brigham Young University, Provo, Utah, USA

More Information

Additional Information:

Technical Report: Evaluation of the UNICEF School-Based Psychosocial Program for War-Exposed Adolescents as Implemented During the 2000-2001 School Year This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A-261 ASB
Study First Received:	May 30, 2007
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00480480 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham Young University:

Trauma
Grief
Depression
Adolescent
War
Group

Therapy
Treatment
Intervention
School
Development

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Mood Disorders
Wounds and Injuries

Stress Disorders, Post-Traumatic
Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Anxiety Disorders
Mental Disorders
Mood Disorders

Stress Disorders, Post-Traumatic
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009