Phase 2
N=76
A School Program for Children Exposed to Violence
Stress Disorders, Post-Traumatic · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00260195 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Post-traumatic Stress Disorder Symptoms — 17.46; 19.41; 13.72; 18.32 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- School-based cognitive behavioral support group (Behavioral)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- RAND
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-traumatic Stress Disorder Symptoms |
17.46; 19.41; 13.72; 18.32; 11.97; 15.59 | — |
| PRIMARY Depressive Symptoms |
13.87; 14.32; 11.77; 14.92; 12.21; 12.91 | — |
| PRIMARY Parent Report of Behavioral Problems |
11.64; 12.46; 9.72; 11.30; 8.41; 8.91 | — |
| PRIMARY Teacher Report of Behavior Problems |
11.33; 8.59; 10.28; 9.30; 10.47; 9.19 | — |
Summary
This study will develop a program to help school children deal with violence-related trauma.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00260195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.