A School Program for Children Exposed to Violence

NCT ID: NCT00260195

Last Updated: 2014-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stress Disorders, Post-Traumatic Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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School-based cognitive behavioral support group

Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.

Group Type EXPERIMENTAL

School-based cognitive behavioral support group

Intervention Type BEHAVIORAL

Wait-list control group

Waiting list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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School-based cognitive behavioral support group

Intervention Type BEHAVIORAL

Other Intervention Names

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Support for Students Exposed to Trauma (SSET)

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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LIsa Jaycox

Senior Behavioral Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa H. Jaycox, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/00004583-200303000-00011.

Reference Type BACKGROUND
PMID: 12595784 (View on PubMed)

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. doi: 10.1007/BF02287371.

Reference Type BACKGROUND
PMID: 12216375 (View on PubMed)

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. doi: 10.1001/jama.290.5.603.

Reference Type BACKGROUND
PMID: 12902363 (View on PubMed)

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. doi: 10.1097/00004583-200209000-00011.

Reference Type BACKGROUND
PMID: 12218432 (View on PubMed)

Other Identifiers

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R01MH072591

Identifier Type: NIH

Identifier Source: secondary_id

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DDTR B3-PDS

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH072591

Identifier Type: NIH

Identifier Source: org_study_id

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