A School Program for Children Exposed to Violence - Full Text View

Purpose

This study will develop a program to help school children deal with violence-related trauma.

Condition	Intervention	Phase
Stress Disorders, Post-Traumatic Depression	Behavioral: School-based cognitive behavioral therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A School Program for Children Exposed to Violence

Resource links provided by NLM:

MedlinePlus related topics: Depression Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Post-traumatic stress disorder symptoms [ Designated as safety issue: No ]
Depressive symptoms
Behavioral problems

Secondary Outcome Measures:

Improved school and social functioning
Improved parent-child communication
Improved peer support

Enrollment:	78
Study Start Date:	July 2005
Study Completion Date:	July 2007

Detailed Description:

The number of children who have been indirectly or directly exposed to violence has dramatically increased in the last decade. The emotional and behavioral consequences of violence exposure can be particularly devastating to children. Interventions are needed that can reduce symptoms related to traumas already experienced and enhance children's skills for handling extreme stress that might be experienced in the future. The Cognitive-Behavioral Intervention for Trauma in Schools (CBITS) program was developed between 1998 and 2001 to help children in the Los Angeles school district deal with traumatic events. Although promising, the program required a school-based mental health clinician for implementation. This study will evaluate the effectiveness of a program adapted for the Los Angeles CBITS program that can be used by school staff in a middle school setting. The adapted CBITS program will be compared to a wait list to determine which is more effective in reducing trauma-related stress and depression among sixth grade students.

Students who have experienced violence-related trauma will be randomly assigned to receive either 10 weekly sessions of group cognitive behavioral therapy or to wait 3 months. Self-report scales and interviews will be used to assess the emotional states of participants at study entry and study completion. No follow-up visits will be required.

Eligibility

Ages Eligible for Study:	12 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Students in 6th and 7th grade in two participating Los Angeles area schools
Exposure to severe violence, as either a victim or witness, within 1 year prior to study entry
Have symptoms of post-traumatic stress disorder at study entry
Able to speak and understand English
Parent or guardian willing to give informed consent

Exclusion Criteria:

Post-traumatic stress disorder symptoms that are not related to a traumatic event
Mental retardation
Conduct disorder that would interfere with the participant's ability to engage in group therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260195

Locations

United States, California
LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center
Los Angeles, California, United States, 90017

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Lisa H. Jaycox, PhD

RAND Corporation

More Information

Publications:

Kataoka SH, Stein BD, Jaycox LH, Wong M, Escudero P, Tu W, Zaragoza C, Fink A. A school-based mental health program for traumatized Latino immigrant children. J Am Acad Child Adolesc Psychiatry. 2003 Mar;42(3):311-8.

Stein BD, Kataoka S, Jaycox LH, Wong M, Fink A, Escudero P, Zaragoza C. Theoretical basis and program design of a school-based mental health intervention for traumatized immigrant children: a collaborative research partnership. J Behav Health Serv Res. 2002 Aug;29(3):318-26.

Stein BD, Jaycox LH, Kataoka SH, Wong M, Tu W, Elliott MN, Fink A. A mental health intervention for schoolchildren exposed to violence: a randomized controlled trial. JAMA. 2003 Aug 6;290(5):603-11.

Jaycox LH, Stein BD, Kataoka SH, Wong M, Fink A, Escudero P, Zaragoza C. Violence exposure, posttraumatic stress disorder, and depressive symptoms among recent immigrant schoolchildren. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1104-10.

Responsible Party:	Lisa Jaycox, RAND Corporation
ClinicalTrials.gov Identifier:	NCT00260195 History of Changes
Other Study ID Numbers:	R01 MH72591, DDTR B3-PDS
Study First Received:	November 29, 2005
Last Updated:	December 10, 2007
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Trauma
Violence
Adolescent
Schools
Cognitive behavioral therapy

Additional relevant MeSH terms:

Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 22, 2013