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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:

U.S. FDA Resources

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

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, Post-Traumatic
Stress Disorders, Traumatic
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 19, 2013