A School Program for Children Exposed to Violence
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00260195 |
|
Recruitment Status :
Completed
First Posted : December 1, 2005
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stress Disorders, Post-Traumatic Depression | Behavioral: School-based cognitive behavioral support group | Phase 2 |
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 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 |
| 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
|
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 10 Years to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, California | |
| LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center | |
| Los Angeles, California, United States, 90017 | |
| Principal Investigator: | Lisa H. Jaycox, PhD | RAND |
| 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 |
|
Trauma Violence Adolescent Schools Cognitive behavioral therapy |
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Mental Disorders |