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A School Program for Children Exposed to Violence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
LIsa Jaycox, RAND
ClinicalTrials.gov Identifier:
NCT00260195
First received: November 29, 2005
Last updated: April 28, 2014
Last verified: April 2014

November 29, 2005
April 28, 2014
July 2005
July 2007   (final data collection date for primary outcome measure)
  • Post-traumatic Stress Disorder Symptoms [ Time Frame: 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). ] [ Designated as safety issue: No ]
    We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, & Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach's alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.
  • Depressive Symptoms [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Children's Depression Inventory (CDI; Kovacs, 1981) This 27-item measure assesses children's cognitive, affective, and behavioral depressive symptoms. The scale has high internal consistency, moderate test-retest reliability, and correlates in the expected direction with measures of related constructs (e.g., self-esteem, negative attributions, and hopelessness; Kendall, Cantwell, & Kazdin, 1989). Normative data are available (Finch, Saylor, & Edwards, 1985). We used a 26-item version of the scale that omits an item about suicidal ideation. Higher scores indicate more symptoms, and total scores can range from 0 to 52.
  • Parent Report of Behavioral Problems [ Time Frame: Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks). ] [ Designated as safety issue: No ]
    Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicate more problems, with total scores for problem areas ranging from 0 to 40.
  • Teacher Report of Behavior Problems [ Time Frame: Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks). ] [ Designated as safety issue: No ]
    Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicates more problems, with total problem area scores ranging from 0 to 40.
  • Post-traumatic stress disorder symptoms
  • Depressive symptoms
  • Behavioral problems
Complete list of historical versions of study NCT00260195 on ClinicalTrials.gov Archive Site
Not Provided
  • Improved school and social functioning
  • Improved parent-child communication
  • Improved peer support
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 support group
Other Name: Support for Students Exposed to Trauma (SSET)
  • Experimental: 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.
    Intervention: Behavioral: School-based cognitive behavioral support group
  • No Intervention: Wait-list control group
    Waiting list

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2009
July 2007   (final data collection date for primary outcome measure)

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
10 Years to 14 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
RAND
National Institute of Mental Health (NIMH)
Principal Investigator: Lisa H. Jaycox, PhD RAND Corporation
RAND
April 2014

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