NCT00480480

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
Last Updated

May 31, 2007

Status Verified

May 1, 2007

First QC Date

May 30, 2007

Last Update Submit

May 30, 2007

Conditions

Posttraumatic Stress DisorderDepressionGrief (Traumatic Grief and Existential Grief)

Keywords

TraumaGriefDepressionAdolescentWarGroupTherapyTreatmentInterventionSchoolDevelopment

Outcome Measures

Primary Outcomes (3)

  • UCLA PTSD Reaction Index

    Pre-treatment, post-treatment, and at 4-month follow-up

  • Depression Self-Rating Scale

    Pre-treatment, post-treatment, and 4-month follow-up

  • UCLA Grief Scale

    Pre-treatment, post-treatment

Secondary Outcomes (6)

  • Cognitive Distortions Scale

    Pre-treatment and post-treatment

  • War Exposure Index

    Pre-treatment (screening survey)

  • Post-War Adversities Scale

    Pre-treatment (screening survey)

  • Trauma Reminder Screening Scale

    Pre-treatment (screening survey)

  • Loss Reminder Screening Scale

    Pre-treatment (screening survey)

  • +1 more secondary outcomes

Interventions

Trauma and Grief Component Therapy for Adolescents (Group Version)BEHAVIORAL

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Acute risk status (e.g., suicidal plans and intent)
  • Psychosis
  • Severe substance abuse (severe enough to interfere with engagement in treatment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionProlonged Grief DisorderWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Christopher M Layne, Ph.D.

    Brigham Young University, Provo, Utah, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

September 1, 2000

Study Completion

October 1, 2001

Last Updated

May 31, 2007

Record last verified: 2007-05