Clinical trial NCT00480480: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Depression
Grief (Traumatic Grief and Existential Grief)
Keywords: Trauma
Grief
Depression
Adolescent
War
Group
Therapy
Treatment
Intervention
School
Development
Lead sponsor: Brigham Young University
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2007-05-31
Enrollment: 144
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: UCLA PTSD Reaction Index
timeFrame: Pre-treatment, post-treatment, and at 4-month follow-up
measure: Depression Self-Rating Scale
timeFrame: Pre-treatment, post-treatment, and 4-month follow-up
measure: UCLA Grief Scale
timeFrame: Pre-treatment, post-treatment
Secondary outcomes:
measure: Cognitive Distortions Scale
timeFrame: Pre-treatment and post-treatment
measure: War Exposure Index
timeFrame: Pre-treatment (screening survey)
measure: Post-War Adversities Scale
timeFrame: Pre-treatment (screening survey)
measure: Trauma Reminder Screening Scale
timeFrame: Pre-treatment (screening survey)
measure: Loss Reminder Screening Scale
timeFrame: Pre-treatment (screening survey)
measure: Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales)
timeFrame: Pre- and post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Brigham Young University, Provo, Utah, USA
name: Christopher M Layne, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: