Pediatric Aggression and Violence
Conditions
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.
Interventions
None listed
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
7 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Inpatient High Aggression The high- risk group was defined as having a BRACHA score ≥ 8. | 9 |
| Inpatient Low Aggression The low- risk group was defined as having a BRACHA score ≤6.5. | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Inpatient Low Aggression | Inpatient High Aggression | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 8 years STANDARD_DEVIATION 1 | 8 years STANDARD_DEVIATION 1 | 8 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Collected on one or two days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Aggression Group + Cortisol Sample1 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 0.8 ul/dL | Standard Deviation 0.9 |
| Low Aggression Group + Cortisol Sample2 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 0.4 ul/dL | Standard Deviation 0.1 |
| Low Aggression Group + Cortisol Sample3 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 0.3 ul/dL | Standard Deviation 0.3 |
| High Aggression Group + Cortisol Sample1 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 0.4 ul/dL | Standard Deviation 0.2 |
| High Aggression Group + Cortisol Sample2 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 0.8 ul/dL | Standard Deviation 0.3 |
| High Aggression Group + Cortisol Sample3 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score | 0.2 ul/dL | Standard Deviation 0.1 |
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.
Time frame: Collected on one or two days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Aggression Group + Cortisol Sample1 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 85.7 pg/mL | Standard Deviation 30.9 |
| Low Aggression Group + Cortisol Sample2 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 121.1 pg/mL | Standard Deviation 64.4 |
| Low Aggression Group + Cortisol Sample3 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 111.9 pg/mL | Standard Deviation 45.8 |
| High Aggression Group + Cortisol Sample1 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 37.3 pg/mL | Standard Deviation 8.2 |
| High Aggression Group + Cortisol Sample2 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 38.8 pg/mL | Standard Deviation 16.5 |
| High Aggression Group + Cortisol Sample3 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 42.7 pg/mL | Standard Deviation 14.4 |
| High Aggression Group + DHEASample1 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 97.3 pg/mL | Standard Deviation 95.1 |
| High Aggression Group + DHEASample2 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 132.3 pg/mL | Standard Deviation 101.6 |
| High Aggression Group + DHEASample3 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 95.5 pg/mL | Standard Deviation 58.2 |
| High Aggression Group + TestosteroneSample1 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 45.1 pg/mL | Standard Deviation 25.8 |
| High Aggression Group + TestosteroneSample2 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 46.9 pg/mL | Standard Deviation 17.8 |
| High Aggression Group + TestosteroneSample3 | Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score. | 37 pg/mL | Standard Deviation 12.5 |