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临床试验/NCT00260195
NCT00260195已完成2 期

A School Program for Children Exposed to Violence

RAND1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2005年7月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
RAND
入组人数
78
试验地点
1
主要终点
Post-traumatic Stress Disorder Symptoms

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

School-based cognitive behavioral support group

Experimental

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.

干预措施: School-based cognitive behavioral support group (Behavioral)

Wait-list control group

No Intervention

Waiting list

结局指标

主要结局

Post-traumatic Stress Disorder Symptoms

时间窗: 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.

Depressive Symptoms

时间窗: 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.

Parent Report of Behavioral Problems

时间窗: 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.

Teacher Report of Behavior Problems

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

LIsa Jaycox

Senior Behavioral Scientist

RAND

研究点 (1)

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