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Pediatric Aggression and Violence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01253343
First received: November 1, 2010
Last updated: May 23, 2013
Last verified: May 2013

November 1, 2010
May 23, 2013
September 2011
November 2012   (final data collection date for primary outcome measure)
  • Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score [ Time Frame: Collected on one or two days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 hormones [ Time Frame: Collected on one day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01253343 on ClinicalTrials.gov Archive Site
Not Provided
BRACHA and The Predatory Affective Aggression Scales [ Time Frame: One Day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pediatric Aggression and Violence
Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Saliva specimens will be retained for future research use for particpants who have given proper consent.

Non-Probability Sample

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.
Pediatric Aggression and Violence
Not Provided
  • inpatient high aggression
  • inpatient low aggression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Male
7 Years to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253343
2010-0892
No
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP