A School Program for Children Exposed to Violence

Depression Clinical Trial

Official title:

A School Program for Children Exposed to Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260195
• Other study ID #: R01MH072591
• Secondary ID: R01MH072591DDTR
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2005
• Last updated: April 28, 2014
• Start date: July 2005
• Est. completion date: July 2009

Study information

• Verified date: April 2014
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• School-based cognitive behavioral support group

Locations

Country	Name	City	State
United States	LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	No
Primary	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.	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).	No
Primary	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.	Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).	No
Primary	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.	Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).	No