- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01253343
Pediatric Aggression and Violence
May 23, 2013 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Childrens Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 9 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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.
Description
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 Predatory-Affective Aggression Scale (PAAS)
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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inpatient high aggression
|
inpatient low aggression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Collected on one or two days
|
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.
|
Collected on one or two days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
August 28, 2013
Last Update Submitted That Met QC Criteria
May 23, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0892
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Aggression and Violence
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Boston UniversityU.S. Department of JusticeCompletedSexual Aggression | Offensive Aggression | Dating Violence Perpetration and VictimizationUnited States
-
Pro-Change Behavior SystemsCompletedViolence | Bullying
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University of MichiganCenters for Disease Control and PreventionRecruitingAdolescent | Aggression | Violence | Firearm InjuryUnited States
-
University of HoustonUnknownAggression | Domestic Violence | Family Conflict | Domestic Abuse
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Georgia State UniversityUniversity at Buffalo; University of LouisvilleCompletedAggression | Stress, Psychological | Violence, Domestic | Alcohol ConsumptionUnited States
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McMaster UniversityRoyal College of Physicians and Surgeons of CanadaActive, not recruitingPediatric ALL | Domestic Violence | Child Maltreatment | Psychiatry | Education, Medical, GraduateCanada
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The University of Texas at San AntonioRecruitingAnger | Aggression | Emotional Distress | Violence | Intermittent Explosive DisorderUnited States
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Hospices Civils de LyonCompletedRudeness/Incivility, Aggression or Violence Against Healthcare Workers in an Ophthalmic Emergencies Unit.France
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Uludag UniversityCompletedViolence | Personality | Exposure to Violent Event | Nursing Student | Workplace BullyingTurkey