Clinical trial NCT00260195: A School Program for Children Exposed to Violence
Official title: A School Program for Children Exposed to Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Disorders, Post-Traumatic
Depression
Keywords: Trauma
Violence
Adolescent
Schools
Cognitive behavioral therapy
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-12-01
Enrollment: 78
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Post-traumatic Stress Disorder Symptoms
timeFrame: Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
measure: Depressive Symptoms
timeFrame: Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
measure: Parent Report of Behavioral Problems
timeFrame: Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
measure: Teacher Report of Behavior Problems
timeFrame: Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center
state: California
Study officials:
affiliation: RAND
name: Lisa H. Jaycox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.