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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inpatient high aggression | |||
| inpatient low aggression |
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| Measure | Description | Time Frame |
|---|---|---|
| Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 24 male subjects (ages 7-11) will be recruited to two groups from inpatient units at CCHMC:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Childrens Hospital | Cincinnati | Ohio | 45229 | United States |
Inclusion criteria included boys aged 7 to 9 years, with BRACHA scores, admitted to a psychiatric inpatient unit. Exclusion criteria included presence of infection requiring antibiotics within 2 weeks, recent surgery within 8 weeks, bleeding gums within 8 weeks of admission, current detainment in juvenile detention, and steroid use.
Between May 2011 and November 2011, we recruited 17 psychiatrically hospitalized boys (ages 7 to 9 years). We categorized the 17 participants into 2 groups, high aggression risk and low aggression risk, based on their initial BRACHA score.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inpatient High Aggression | The high- risk group was defined as having a BRACHA score >7.5. |
| FG001 | Inpatient Low Aggression | The low- risk group was defined as having a BRACHA score <7.5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inpatient High Aggression | The high- risk group was defined as having a BRACHA score ≥ 8. |
| BG001 | Inpatient Low Aggression | The low- risk group was defined as having a BRACHA score ≤6.5. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 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. | The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants. | Posted | Mean | Standard Deviation | ul/dL | Collected on one or two days |
|
6 months
No AEs were reported. This was a less than minimal risk study. The saliva collection was the only procedure conducted and is non-invasive.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inpatient High Aggression | The high- risk group was defined as having a BRACHA score >7.5. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Drew Barzman | Cincinnati Children's Hospital Medical Center | 513-636-4788 | drew.barzman@cchmc.org |
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Saliva specimens will be retained for future research use for particpants who have given proper consent.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing |
| OG001 | Low Aggression Group + Cortisol Sample2 | Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1 |
| OG002 | Low Aggression Group + Cortisol Sample3 | Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food. |
| OG003 | High Aggression Group + Cortisol Sample1 | High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing |
| OG004 | High Aggression Group + Cortisol Sample2 | High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1 |
| OG005 | High Aggression Group + Cortisol Sample3 | High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food. |
|
|
| Primary | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 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. | The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants. | Posted | Mean | Standard Deviation | pg/mL | Collected on one or two days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Inpatient Low Aggression | The low- risk group was defined as having a BRACHA score <7.5. | 0 | 0 | 0 | 0 |
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