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A School Program for Children Exposed to Violence

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ClinicalTrials.gov Identifier: NCT00260195
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
LIsa Jaycox, RAND

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

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Depression Behavioral: School-based cognitive behavioral support group Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A School Program for Children Exposed to Violence
Study Start Date : July 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: School-based cognitive behavioral support group
Other Name: Support for Students Exposed to Trauma (SSET)
No Intervention: Wait-list control group
Waiting list


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]
    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.

  2. 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). ]
    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.

  3. 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). ]
    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.

  4. 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). ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260195


Locations
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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
RAND
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lisa H. Jaycox, PhD RAND
More Information
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Publications:

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Responsible Party: LIsa Jaycox, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT00260195    
Other Study ID Numbers: R01MH072591 ( U.S. NIH Grant/Contract )
R01MH072591 ( U.S. NIH Grant/Contract )
DDTR B3-PDS ( Other Identifier: FDAAA )
First Posted: December 1, 2005    Key Record Dates
Results First Posted: May 22, 2014
Last Update Posted: May 22, 2014
Last Verified: April 2014
Keywords provided by LIsa Jaycox, RAND:
Trauma
Violence
Adolescent
Schools
Cognitive behavioral therapy
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders