Skip to main content
Clinical Trials/NCT01253343
NCT01253343CompletedNot Applicable

Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study

Children's Hospital Medical Center, Cincinnati1 site in 1 country17 target enrollmentStarted: September 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.

Study Overview

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 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
7 Years to 9 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.

Time Frame: Collected on one or two days

We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.

Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score

Time Frame: Collected on one or two days

We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials