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NCT01253343 · ClinicalTrials.gov registry record

Pediatric Aggression and Violence

A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
17
Enrollment target

NCT01253343: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01253343 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01253343 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
17 participants
Enrollment target

Study 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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2011-09
Est. Completion 2012-11

What the finished NCT01253343 record still lists

NCT01253343 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01253343 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01253343 about?

NCT01253343 is a clinical study titled "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...

What is the current status of trial NCT01253343?

This trial is currently completed. The enrollment target is 17 participants. The study started on 2011-09. Estimated completion is 2012-11.

Who is sponsoring clinical trial NCT01253343?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01253343, the US trial registry maintained by the National Library of Medicine. NCT01253343 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.