Status:
COMPLETED
Pediatric Aggression and Violence
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pediatric Aggression and Violence
Eligibility:
MALE
7-9 years
Brief Summary
Violence and aggression on pediatric psychiatry units has led to staff and patient injuries and even deaths around the country. In an effort to improve safety, the investigators have developed a metho...
Eligibility Criteria
Inclusion
- Prepubescent males (per parent report), African American or Caucasian, between 7 and 9 years old
- Ability of the subject to provide assent
- Ability of the guardian to give parental permission
- Completion of the BRACHA questionnaire
- Completion of the Predatory-Affective Aggression Scale (PAAS)
Exclusion
- Viral or bacterial infection or treatment with antibiotics within two weeks of screening
- Recent surgery (within 8 weeks of screening)
- Bleeding gums (within 8 weeks of screening)
- Currently detained in a juvenile detention
- Currently taking medications such as antipsychotic medications (besides Aripiprazole), steroids and beta adrenergic agonists that affect hormones
- If it is the investigator's clinical judgment that the subject should be excluded if it is in the subject's best interest or due to any other factor that may interfere with study results
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01253343
Start Date
September 1 2011
End Date
November 1 2012
Last Update
August 28 2013
Active Locations (1)
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1
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229