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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480480
First Posted: May 31, 2007
Last Update Posted: May 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UNICEF
Information provided by:
Brigham Young University
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00480480     History of Changes
Other Study ID Numbers: A-261 ASB
First Submitted: May 30, 2007
First Posted: May 31, 2007
Last Update Posted: May 31, 2007
Last Verified: May 2007

Keywords provided by Brigham Young University:
Trauma
Grief
Depression
Adolescent
War
Group
Therapy
Treatment
Intervention
School
Development

Additional relevant MeSH terms:
Depression
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders