Completed

NCT Number: NCT01253343

Pediatric Aggression and Violence

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.

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Key information

Conditions

Pediatric Aggression and Violence

Age range

7 year–9 year

Sex eligibility

Male

Study type

Observational

Primary location

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 3, 2010
Registry last updated: Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.