Trial Outcomes & Findings for Pediatric Aggression and Violence (NCT NCT01253343)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

Collected on one or two days

Results posted on

2013-08-28

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Inpatient High Aggression The high- risk group was defined as having a BRACHA score \>7.5.	Inpatient Low Aggression The low- risk group was defined as having a BRACHA score \<7.5.
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pediatric Aggression and Violence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inpatient High Aggression n=9 Participants The high- risk group was defined as having a BRACHA score ≥ 8.	Inpatient Low Aggression n=8 Participants The low- risk group was defined as having a BRACHA score ≤6.5.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	8 years STANDARD_DEVIATION 1 • n=5 Participants	8 years STANDARD_DEVIATION 1 • n=7 Participants	8 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Low Aggression Group + Cortisol Sample1 n=8 Participants Low Aggression= BRACHA Score \<7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	Low Aggression Group + Cortisol Sample2 n=6 Participants Low Aggression= BRACHA Score \<7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	Low Aggression Group + Cortisol Sample3 n=6 Participants 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.	High Aggression Group + Cortisol Sample1 n=9 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	High Aggression Group + Cortisol Sample2 n=9 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	High Aggression Group + Cortisol Sample3 n=9 Participants 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.	High Aggression Group + DHEASample1 High Aggression= BRACHA Score \>7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	High Aggression Group + DHEASample2 High Aggression= BRACHA Score \>7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	High Aggression Group + DHEASample3 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.	High Aggression Group + TestosteroneSample1 High Aggression= BRACHA Score \>7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	High Aggression Group + TestosteroneSample2 High Aggression= BRACHA Score \>7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	High Aggression Group + TestosteroneSample3 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.
Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score	0.8 ul/dL Standard Deviation 0.9 • Interval 2.0 to 3.0	0.4 ul/dL Standard Deviation 0.1 • Interval 2.0 to 3.0	0.3 ul/dL Standard Deviation 0.3	0.4 ul/dL Standard Deviation 0.2	0.8 ul/dL Standard Deviation 0.3	0.2 ul/dL Standard Deviation 0.1	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Low Aggression Group + Cortisol Sample1 n=8 Participants Low Aggression= BRACHA Score \<7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	Low Aggression Group + Cortisol Sample2 n=6 Participants Low Aggression= BRACHA Score \<7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	Low Aggression Group + Cortisol Sample3 n=6 Participants 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.	High Aggression Group + Cortisol Sample1 n=8 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	High Aggression Group + Cortisol Sample2 n=6 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	High Aggression Group + Cortisol Sample3 n=6 Participants 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.	High Aggression Group + DHEASample1 n=9 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	High Aggression Group + DHEASample2 n=9 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	High Aggression Group + DHEASample3 n=9 Participants 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.	High Aggression Group + TestosteroneSample1 n=9 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing	High Aggression Group + TestosteroneSample2 n=9 Participants High Aggression= BRACHA Score \>7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1	High Aggression Group + TestosteroneSample3 n=9 Participants 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.
Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.	85.7 pg/mL Standard Deviation 30.9	121.1 pg/mL Standard Deviation 64.4	111.9 pg/mL Standard Deviation 45.8	37.3 pg/mL Standard Deviation 8.2	38.8 pg/mL Standard Deviation 16.5	42.7 pg/mL Standard Deviation 14.4	97.3 pg/mL Standard Deviation 95.1	132.3 pg/mL Standard Deviation 101.6	95.5 pg/mL Standard Deviation 58.2	45.1 pg/mL Standard Deviation 25.8	46.9 pg/mL Standard Deviation 17.8	37 pg/mL Standard Deviation 12.5

Adverse Events

Inpatient High Aggression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inpatient Low Aggression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Drew Barzman

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place