Stress Disorders, Post-TraumaticPhase 2NCT00260195
A School Program for Children Exposed to Violence
A Phase 2 study testing School-based cognitive behavioral support group in people with Stress Disorders, Post-Traumatic and Depression, run by RAND at 1 site in United States.
Trial summary
This study will develop a program to help school children deal with violence-related trauma. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression
- What is being tested?
- School-based cognitive behavioral support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LAUSD Crisis Counseling and Intervention Services, LAUSD/RAND/UCLA Trauma Services Adaptation Center
Los Angeles, California, 90017
About this study
This study will develop a program to help school children deal with violence-related trauma.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Depression
- Being tested
- School-based cognitive behavioral support group
- Keywords
- Trauma, Violence, Adolescent, Schools, Cognitive behavioral therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based cognitive behavioral support groupBehavioural
Also called Support for Students Exposed to Trauma (SSET)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: School-based cognitive behavioral support group |
| Wait-list control group | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
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.
Measured: Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, LIsa Jaycox, RAND
- Investigators
- Lisa H. Jaycox, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260195
- Sponsor's protocol ID
- R01MH072591
- Other IDs
- R01MH072591, DDTR B3-PDS
- Status last verified
- Apr 2014
- First submitted
- 29 Nov 2005
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12595784Stein 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.
PubMed 12216375Stein 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.
PubMed 12902363Jaycox 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.
PubMed 12218432
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School Program for Children Exposed to Violence
- ClinicalTrials.gov ID
- NCT00260195
- Acronym / sponsor ID
- R01MH072591
- Conditions
- Stress Disorders, Post-Traumatic, Depression
- Keywords
- Trauma, Violence, Adolescent, Schools, Cognitive behavioral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-based cognitive behavioral support group | Experimental | Behavioral: School-based cognitive behavioral support groupTen 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. |
| Wait-list control group | No intervention | –Waiting list |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based cognitive behavioral support groupAlso: Support for Students Exposed to Trauma (SSET) | Behavioural | School-based cognitive behavioral support group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12595784Kataoka 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.
- Background: PubMed 12216375Stein 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.
- Background: PubMed 12902363Stein 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.
- Background: PubMed 12218432Jaycox 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa H. Jaycox, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing School-based cognitive behavioral support group in people with Stress Disorders, Post-Traumatic and Depression, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.