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A School Program for Children Exposed to Violence

Primary Purpose

Stress Disorders, Post-Traumatic, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
School-based cognitive behavioral support group
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Trauma, Violence, Adolescent, Schools, Cognitive behavioral therapy

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

School-based cognitive behavioral support group

Wait-list control group

Arm Description

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.

Waiting list

Outcomes

Primary Outcome Measures

Post-traumatic Stress Disorder Symptoms
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2005
Last Updated
April 28, 2014
Sponsor
RAND
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00260195
Brief Title
A School Program for Children Exposed to Violence
Official Title
A School Program for Children Exposed to Violence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Depression
Keywords
Trauma, Violence, Adolescent, Schools, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
School-based cognitive behavioral support group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
Waiting list
Intervention Type
Behavioral
Intervention Name(s)
School-based cognitive behavioral support group
Other Intervention Name(s)
Support for Students Exposed to Trauma (SSET)
Primary Outcome Measure Information:
Title
Post-traumatic Stress Disorder Symptoms
Description
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.
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).
Title
Depressive Symptoms
Description
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.
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).
Title
Parent Report of Behavioral Problems
Description
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.
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).
Title
Teacher Report of Behavior Problems
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa H. Jaycox, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12595784
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.
Results Reference
background
PubMed Identifier
12216375
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.
Results Reference
background
PubMed Identifier
12902363
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.
Results Reference
background
PubMed Identifier
12218432
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.
Results Reference
background

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A School Program for Children Exposed to Violence

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