Pediatric Aggression and Violence

Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study

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 Overview

• Status: Completed
• Conditions: Pediatric Aggression and Violence

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

A total of 24 male subjects (ages 7-11) will be recruited to two groups from inpatient units at CCHMC:

1. Inpatient high aggression: Twelve inpatient males (6 African-American and 6 Caucasian) will be recruited based on completion of the BRACHA and the Predatory-Affective Aggression Scale.
2. Inpatient low aggression: Twelve inpatient males (6 African-American and 6 Caucasian) will be recruited based on completion of the BRACHA and the Predatory-Affective Aggression Scales.

Description

Inclusion Criteria:

1. Prepubescent males (per parent report), African American or Caucasian, between 7 and 9 years old
2. Ability of the subject to provide assent
3. Ability of the guardian to give parental permission
4. Completion of the BRACHA questionnaire
5. Completion of the Predatory-Affective Aggression Scale (PAAS)

Exclusion Criteria:

1. Viral or bacterial infection or treatment with antibiotics within two weeks of screening
2. Recent surgery (within 8 weeks of screening)
3. Bleeding gums (within 8 weeks of screening)
4. Currently detained in a juvenile detention
5. Currently taking medications such as antipsychotic medications (besides Aripiprazole), steroids and beta adrenergic agonists that affect hormones
6. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
inpatient high aggression
inpatient low aggression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score	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.	Collected on one or two days
Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.	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.	Collected on one or two days

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: May 23, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: 2010-0892