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

Sponsor
Brigham Young University (Other)
Overall Status
Completed
CT.gov ID
NCT00480480
Collaborator
UNICEF (Other)
144
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trauma and Grief Component Therapy for Adolescents (Group Version)
N/A

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

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers
Study Start Date :
Sep 1, 2000
Actual Study Completion Date :
Oct 1, 2001

Outcome Measures

Primary Outcome Measures

  1. UCLA PTSD Reaction Index [Pre-treatment, post-treatment, and at 4-month follow-up]

  2. Depression Self-Rating Scale [Pre-treatment, post-treatment, and 4-month follow-up]

  3. UCLA Grief Scale [Pre-treatment, post-treatment]

Secondary Outcome Measures

  1. Cognitive Distortions Scale [Pre-treatment and post-treatment]

  2. War Exposure Index [Pre-treatment (screening survey)]

  3. Post-War Adversities Scale [Pre-treatment (screening survey)]

  4. Trauma Reminder Screening Scale [Pre-treatment (screening survey)]

  5. Loss Reminder Screening Scale [Pre-treatment (screening survey)]

  6. Youth Outcome Questionnaire (Somatic and Interpersonal Problems Subscales) [Pre- and post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham Young University
  • UNICEF

Investigators

  • Principal Investigator: Christopher M Layne, Ph.D., Brigham Young University, Provo, Utah, USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00480480
Other Study ID Numbers:
  • A-261 ASB
First Posted:
May 31, 2007
Last Update Posted:
May 31, 2007
Last Verified:
May 1, 2007

Study Results

No Results Posted as of May 31, 2007