NCT Number: NCT00480480
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
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.
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Notify MeKey information
Conditions
Age range
14 year–19 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
Brigham Young University
Other
Collaborators
- UNICEF
Registry information
Official study title
Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers
Important dates
- Study start
- 2000
- Study completion
- 2001
- First posted
- May 31, 2007
- Registry last updated
- May 31, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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