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Pediatric Aggression and Violence

NCT ID: NCT01253343

Last Updated: 2013-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Aggression and Violence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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inpatient high aggression

No interventions assigned to this group

inpatient low aggression

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Childrens Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2010-0892

Identifier Type: -

Identifier Source: org_study_id