A School Program for Children Exposed to Violence

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
RAND
ClinicalTrials.gov Identifier:
NCT00260195
First received: November 29, 2005
Last updated: November 1, 2013
Last verified: November 2013

November 29, 2005
November 1, 2013
July 2005
Not Provided
  • Post-traumatic stress disorder symptoms [ Designated as safety issue: No ]
  • Depressive symptoms
  • Behavioral problems
  • Post-traumatic stress disorder symptoms
  • Depressive symptoms
  • Behavioral problems
Complete list of historical versions of study NCT00260195 on ClinicalTrials.gov Archive Site
  • Improved school and social functioning
  • Improved parent-child communication
  • Improved peer support
Same as current
Not Provided
Not Provided
 
A School Program for Children Exposed to Violence
A School Program for Children Exposed to Violence

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Depression
Behavioral: School-based cognitive behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2007
Not Provided

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
Both
12 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00260195
R01 MH72591, R01MH072591, DDTR B3-PDS
No
Lisa Jaycox, RAND Corporation
RAND
National Institute of Mental Health (NIMH)
Principal Investigator: Lisa H. Jaycox, PhD RAND Corporation
RAND
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP