Back to resultsRandomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
Primary Purpose
Posttraumatic Stress Disorder, Depression, Grief (Traumatic Grief and Existential Grief)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trauma and Grief Component Therapy for Adolescents (Group Version)
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Trauma, Grief, Depression, Adolescent, War, Group, Therapy, Treatment, Intervention, School, Development
Eligibility 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).
Sites / Locations
Outcomes
Primary Outcome Measures
UCLA PTSD Reaction Index
Depression Self-Rating Scale
UCLA Grief Scale
Secondary Outcome Measures
Cognitive Distortions Scale
War Exposure Index
Post-War Adversities Scale
Trauma Reminder Screening Scale
Loss Reminder Screening Scale
Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales)
Full Information
NCT ID
NCT00480480
First Posted
May 30, 2007
Last Updated
May 30, 2007
Sponsor
Brigham Young University
Collaborators
UNICEF
1. Study Identification
Unique Protocol Identification Number
NCT00480480
Brief Title
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
Official Title
Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brigham Young University
Collaborators
UNICEF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression, Grief (Traumatic Grief and Existential Grief)
Keywords
Trauma, Grief, Depression, Adolescent, War, Group, Therapy, Treatment, Intervention, School, Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Trauma and Grief Component Therapy for Adolescents (Group Version)
Primary Outcome Measure Information:
Title
UCLA PTSD Reaction Index
Time Frame
Pre-treatment, post-treatment, and at 4-month follow-up
Title
Depression Self-Rating Scale
Time Frame
Pre-treatment, post-treatment, and 4-month follow-up
Title
UCLA Grief Scale
Time Frame
Pre-treatment, post-treatment
Secondary Outcome Measure Information:
Title
Cognitive Distortions Scale
Time Frame
Pre-treatment and post-treatment
Title
War Exposure Index
Time Frame
Pre-treatment (screening survey)
Title
Post-War Adversities Scale
Time Frame
Pre-treatment (screening survey)
Title
Trauma Reminder Screening Scale
Time Frame
Pre-treatment (screening survey)
Title
Loss Reminder Screening Scale
Time Frame
Pre-treatment (screening survey)
Title
Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales)
Time Frame
Pre- and post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Layne, Ph.D.
Organizational Affiliation
Brigham Young University, Provo, Utah, USA
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
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