Pediatric Aggression and Violence

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT01253343

First received: November 1, 2010

Last updated: January 12, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 1, 2010
Last Updated Date	January 12, 2012
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 24, 2011)	Salivary hormones [ Time Frame: Collected on one or two days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 2, 2010)	Salivary hormones [ Time Frame: Collected on one day ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01253343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 2, 2010)	BRACHA and The Predatory Affective Aggression Scales [ Time Frame: One Day ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pediatric Aggression and Violence
Official Title ^ICMJE	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 ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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: 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. 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 ^ICMJE	Pediatric Aggression and Violence
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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 ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	24
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Prepubescent males (per parent report), African American or Caucasian, between 7 and 9 years old Ability of the subject to provide assent Ability of the guardian to give parental permission Completion of the BRACHA questionnaire Completion of the PAAS questionnaire Exclusion Criteria: Viral or bacterial infection or treatment with antibiotics within two weeks of screening Recent surgery (within 8 weeks of screening) Bleeding gums (within 8 weeks of screening) Currently detained in a juvenile detention Currently taking medications such as antipsychotic medications (besides Aripiprazole), steroids and beta adrenergic agonists that affect hormones 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
Gender	Male
Ages	7 Years to 9 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01253343
Other Study ID Numbers ^ICMJE	2010-0892
Has Data Monitoring Committee	No
Responsible Party	Children's Hospital Medical Center, Cincinnati
Study Sponsor ^ICMJE	Children's Hospital Medical Center, Cincinnati
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Children's Hospital Medical Center, Cincinnati
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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