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

This study has been completed.
Sponsor:
Collaborator:
UNICEF
Information provided by:
Brigham Young University
ClinicalTrials.gov Identifier:
NCT00480480
First received: May 30, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on October 01, 2014