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Pediatric Aggression and Violence

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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:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pediatric Aggression and Violence
Enrollment 17
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.
Arm/Group Title Inpatient High Aggression Inpatient Low Aggression
Hide Arm/Group Description The high- risk group was defined as having a BRACHA score >7.5. The low- risk group was defined as having a BRACHA score <7.5.
Period Title: Overall Study
Started 9 8
Completed 9 8
Not Completed 0 0
Arm/Group Title Inpatient High Aggression Inpatient Low Aggression Total
Hide Arm/Group Description The high- risk group was defined as having a BRACHA score ≥ 8. The low- risk group was defined as having a BRACHA score ≤6.5. Total of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
<=18 years
9
 100.0%
8
 100.0%
17
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
8  (1) 8  (1) 8  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
8
 100.0%
17
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 8 participants 17 participants
9 8 17
1.Primary Outcome
Title Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Low Aggression Group + Cortisol Sample1 Low Aggression Group + Cortisol Sample2 Low Aggression Group + Cortisol Sample3 High Aggression Group + Cortisol Sample1 High Aggression Group + Cortisol Sample2 High Aggression Group + Cortisol Sample3
Hide Arm/Group Description:
Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
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= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
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.
Overall Number of Participants Analyzed 8 6 6 9 9 9
Mean (Standard Deviation)
Unit of Measure: ul/dL
0.8  (0.9) 0.4  (0.1) 0.3  (0.3) 0.4  (0.2) 0.8  (0.3) 0.2  (0.1)
2.Primary Outcome
Title Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Low Aggression Group + DHEA Sample1 Low Aggression Group + DHEA Sample2 Low Aggression Group + DHEA Sample3 Low Aggression Group + TestosteroneSample1 Low Aggression Group + TestosteroneSample2 Low Aggression Group + TestosteroneSample3 High Aggression Group + DHEASample1 High Aggression Group + DHEASample2 High Aggression Group + DHEASample3 High Aggression Group + TestosteroneSample1 High Aggression Group + TestosteroneSample2 High Aggression Group + TestosteroneSample3
Hide Arm/Group Description:
Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
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.
Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
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= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
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= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
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.
Overall Number of Participants Analyzed 8 6 6 8 6 6 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: pg/mL
85.7  (30.9) 121.1  (64.4) 111.9  (45.8) 37.3  (8.2) 38.8  (16.5) 42.7  (14.4) 97.3  (95.1) 132.3  (101.6) 95.5  (58.2) 45.1  (25.8) 46.9  (17.8) 37  (12.5)
Time Frame 6 months
Adverse Event Reporting Description No AEs were reported. This was a less than minimal risk study. The saliva collection was the only procedure conducted and is non-invasive.
 
Arm/Group Title Inpatient High Aggression Inpatient Low Aggression
Hide Arm/Group Description The high- risk group was defined as having a BRACHA score >7.5. The low- risk group was defined as having a BRACHA score <7.5.
All-Cause Mortality
Inpatient High Aggression Inpatient Low Aggression
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Inpatient High Aggression Inpatient Low Aggression
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inpatient High Aggression Inpatient Low Aggression
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Drew Barzman
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-4788
EMail: drew.barzman@cchmc.org
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01253343     History of Changes
Other Study ID Numbers: 2010-0892
First Submitted: November 1, 2010
First Posted: December 3, 2010
Results First Submitted: November 19, 2012
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013