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Pediatric Aggression and Violence

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ClinicalTrials.gov Identifier: NCT01253343
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date November 1, 2010
First Posted Date December 3, 2010
Results First Submitted Date November 19, 2012
Results First Posted Date August 28, 2013
Last Update Posted Date August 28, 2013
Study Start Date September 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2013)
  • 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.
Original Primary Outcome Measures
 (submitted: December 2, 2010)
Salivary hormones [ Time Frame: Collected on one day ]
Change History Complete list of historical versions of study NCT01253343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: December 2, 2010)
BRACHA and The Predatory Affective Aggression Scales [ Time Frame: One Day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Aggression and Violence
Official Title Salivary Hormones and Pediatric Aggression and Violence: A Feasibility Study
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva specimens will be retained for future research use for particpants who have given proper consent.
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.
Condition Pediatric Aggression and Violence
Intervention Not Provided
Study Groups/Cohorts
  • inpatient high aggression
  • inpatient low aggression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2013)
17
Original Estimated Enrollment
 (submitted: December 2, 2010)
24
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 7 Years to 9 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01253343
Other Study ID Numbers 2010-0892
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators Not Provided
Investigators Not Provided
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date May 2013