N/A
N=17
Pediatric Aggression and Violence
Pediatric Aggression and Violence
Bottom Line
View on ClinicalTrials.gov: NCT01253343 ↗Enrolled (actual)
17
Serious AEs
—
Results posted
Aug 2013
Primary outcome: Primary: Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score — 0.8; 0.4; 0.3; 0.4 ul/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 7+ yrs
- Sex
- Male
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score |
0.8; 0.4; 0.3; 0.4; 0.8; 0.2 | — |
| PRIMARY Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. |
85.7; 121.1; 111.9; 37.3; 38.8; 42.7 | — |
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 method (with the Brief Rating of Child and Adolescent Aggression) of identifying children and adolescents at a higher risk for aggression and violence on the units. In order to improve this prediction, the investigators plan to study salivary hormones in low risk children and high risk children. The salivary hormones to be studied include cortisol, testosterone, and dehydroepiandrosterone sulfate (DHEAS). The investigators expect to improve the investigators current ability to predict the severity and type of pediatric aggression and violence on the inpatient units by combining information from the Brief Rating of Child and Adolescent Aggression (BRACHA), the Predatory-Affective Aggression Scale (Vitiello et al., 1990), and salivary hormones.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01253343). 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.