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临床试验/NCT01253343
NCT01253343已完成不适用

Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 9 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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