A School Program for Children Exposed to Violence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
LIsa Jaycox, RAND
ClinicalTrials.gov Identifier:
NCT00260195
First received: November 29, 2005
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stress Disorders, Post-Traumatic
Depression
Intervention: Behavioral: School-based cognitive behavioral support group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited and screened 6th and 7th grade students in two schools over two school years (2005-2006 and 2006-2007) in Los Angeles Unified School District.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There are 3 steps in enrollment: consent for screening, screening, consent for participation for those who screened positive. 383 students were screened, 193 screened positive, 78 consented for the project (active parental consent and child assent). 2 students withdrew from the school prior groups and thus did not participate further.

Reporting Groups
  Description
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.
Wait-list Control Group Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.

Participant Flow:   Overall Study
    School-based Cognitive Behavioral Support Group     Wait-list Control Group  
STARTED     39     37  
COMPLETED     39     37  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
Wait-list Control Group Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
Total Total of all reporting groups

Baseline Measures
    School-based Cognitive Behavioral Support Group     Wait-list Control Group     Total  
Number of Participants  
[units: participants]
  39     37     76  
Age  
[units: participants]
     
<=18 years     39     37     76  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.4  ± 0.6     11.5  ± 0.7     11.5  ± 0.7  
Gender  
[units: participants]
     
Female     21     18     39  
Male     18     19     37  
Region of Enrollment  
[units: participants]
     
United States     39     37     76  



  Outcome Measures
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1.  Primary:   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). ]

2.  Primary:   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). ]

3.  Primary:   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). ]

4.  Primary:   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). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Jaycox
Organization: RAND Corporation
phone: 703-344-8236 ext 5118
e-mail: jaycox@rand.org


Publications:

Responsible Party: LIsa Jaycox, RAND
ClinicalTrials.gov Identifier: NCT00260195     History of Changes
Other Study ID Numbers: R01 MH72591, R01MH072591, DDTR B3-PDS
Study First Received: November 29, 2005
Results First Received: November 27, 2013
Last Updated: April 28, 2014
Health Authority: United States: Federal Government