Posttraumatic Stress DisorderNCT00480480
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents
A study testing Trauma and Grief Component Therapy for Adolescents (Group Version) in people with Posttraumatic Stress Disorder and Depression, run by Brigham Young University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Grief (Traumatic Grief and Existential Grief)
- What is being tested?
- Trauma and Grief Component Therapy for Adolescents (Group Version)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Oct 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Acute risk status (e.g., suicidal plans and intent)
- Psychosis
- Severe substance abuse (severe enough to interfere with engagement in treatment).
About this study
Official title: 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.
Read the 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.
- Being tested
- Trauma and Grief Component Therapy for Adolescents (Group Version)
- Keywords
- Trauma, Grief, Depression, Adolescent, War, Group, Therapy, Treatment, Intervention, School, Development
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Prolonged Grief Disorder, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma and Grief Component Therapy for Adolescents (Group Version)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA PTSD Reaction Index
Measured: Pre-treatment, post-treatment, and at 4-month follow-up
Depression Self-Rating Scale
Measured: Pre-treatment, post-treatment, and 4-month follow-up
UCLA Grief Scale
Measured: Pre-treatment, post-treatment
Secondary outcomes (6)
Cognitive Distortions Scale
Measured: Pre-treatment and post-treatment
War Exposure Index
Measured: Pre-treatment (screening survey)
Post-War Adversities Scale
Measured: Pre-treatment (screening survey)
Trauma Reminder Screening Scale
Measured: Pre-treatment (screening survey)
Loss Reminder Screening Scale
Measured: Pre-treatment (screening survey)
Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales)
Measured: Pre- and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startSep 2000
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham Young University
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Investigators
- Christopher M Layne, Ph.D., Principal investigator, Brigham Young University, Provo, Utah, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480480
- Sponsor's protocol ID
- A-261 ASB
- Status last verified
- May 2007
- First submitted
- 30 May 2007
- Last updated
- 31 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers
- ClinicalTrials.gov ID
- NCT00480480
- Acronym / sponsor ID
- A-261 ASB
- Keywords
- Trauma, Grief, Depression, Adolescent, War, Group, Therapy, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Brigham Young UniversityUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Sep 2000
- Study completion
- Oct 2001 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Acute risk status (e.g., suicidal plans and intent)
- Psychosis
- Severe substance abuse (severe enough to interfere with engagement in treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma and Grief Component Therapy for Adolescents (Group Version) | Behavioural | – |
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2007.
Related trials for Posttraumatic Stress Disorder
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EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder
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Mindful RAVANS Study
mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
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Predictors & Mechanisms of Adolescent PTSD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher M Layne, Ph.D. principal investigator
Brigham Young University, Provo, Utah, USA
Questions about this trial
What is this clinical trial studying?
A study testing Trauma and Grief Component Therapy for Adolescents (Group Version) in people with Posttraumatic Stress Disorder and Depression, run by Brigham Young University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA PTSD Reaction Index (time frame: Pre-treatment, post-treatment, and at 4-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2007; AzTrials last refreshed its copy on 7 Nov 2026.