- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00480480
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
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
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher M Layne, Ph.D., Brigham Young University, Provo, Utah, USA
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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