Pediatric Aggression and Violence

• 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: Children's Hospital Medical Center, Cincinnati
• 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

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

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