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Pediatric Aggression and Violence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253343
First Posted: December 3, 2010
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose
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.

Condition
Pediatric Aggression and Violence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Saliva specimens will be retained for future research use for particpants who have given proper consent.

Enrollment: 17
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
inpatient high aggression
inpatient low aggression

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253343


Locations
United States, Ohio
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01253343     History of Changes
Other Study ID Numbers: 2010-0892
First Submitted: November 1, 2010
First Posted: December 3, 2010
Results First Submitted: November 19, 2012
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms