Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents

Depression Clinical Trial

Official title:

Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480480
• Other study ID #: A-261 ASB
• Status: Completed
• Phase: N/A
• First received: May 30, 2007
• Last updated: May 30, 2007
• Start date: September 2000
• Est. completion date: October 2001

Study information

• Verified date: May 2007
• Source: Brigham Young University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Grief (Traumatic Grief and Existential Grief)
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma and Grief Component Therapy for Adolescents (Group Version)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham Young University	UNICEF

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCLA PTSD Reaction Index		Pre-treatment, post-treatment, and at 4-month follow-up
Primary	Depression Self-Rating Scale		Pre-treatment, post-treatment, and 4-month follow-up
Primary	UCLA Grief Scale		Pre-treatment, post-treatment
Secondary	Cognitive Distortions Scale		Pre-treatment and post-treatment
Secondary	War Exposure Index		Pre-treatment (screening survey)
Secondary	Post-War Adversities Scale		Pre-treatment (screening survey)
Secondary	Trauma Reminder Screening Scale		Pre-treatment (screening survey)
Secondary	Loss Reminder Screening Scale		Pre-treatment (screening survey)
Secondary	Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales)		Pre- and post-treatment

External Links

•   Technical Report: Evaluation of the UNICEF School-Based Psychosocial Program for War-Exposed Adolescents as Implemented During the 2000-2001 School Year