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

NCT ID: NCT00480480

Last Updated: 2007-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2001-10-31

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder Depression Grief (Traumatic Grief and Existential Grief)

Keywords

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Trauma Grief Depression Adolescent War Group Therapy Treatment Intervention School Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Trauma and Grief Component Therapy for Adolescents (Group Version)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UNICEF

OTHER

Sponsor Role collaborator

Brigham Young University

OTHER

Sponsor Role lead

Principal Investigators

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Christopher M Layne, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham Young University, Provo, Utah, USA

Other Identifiers

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A-261 ASB

Identifier Type: -

Identifier Source: org_study_id