Pediatric Inpatient Firearm Safety Study
Phase: NA
Conditions: Firearm Safety
Sponsor: Montefiore Medical Center

Pediatric Inpatient Firearms Study
Principal Investigator: 
Alyssa Silver
Co-Investigators: 
Gabriella Azzarone
Mimi Kim
Katherine O’Connor
Nancy Dodson
Michael Rinke, MD
Jorge Aguilar, MS4
Casey Pitts, MS4
BACKGROUND
The United States (US) is the only developed country in which firearm violence is a 
major cause of death. Of all firearm deaths in high-income countries, 80% occur in 
the US.1  Gun violence remains a top killer of young people in the U.S. In the year 
2014, 2,549 young people (ages 0-19 years) were killed with a firearm in the US, 
most of whom were 15-19 years.2  Firearm injuries and deaths can be categorized as 
homicides, suicides, unintentional shootings, legal intervention (police 
involvement), or undetermined.  Unintentional shootings comprise 4% of all 
pediatric firearm deaths and often involve young children. Homicide and suicide, 
which comprise 94% of pediatric gun death, overwhelmingly affect teens.3 Urban 
teen males suffer from high rates of gun homicide, while rural teen males die from 
gun suicide.4 
In addition to the pediatric mortality associated with firearm violence, firearm 
injuries leading to hospitalization and other morbidities are a substantial public 
health issue that is less well-studied. In 2009, there were over 7300 hospitalizations 
of children and adolescents due to firearm injuries in the US, with nearly 3 children 
per day under the age of 15 being hospitalized for firearm related injuries.5
The American Academy of Pediatrics recommends a firearm-free household as the 
safest environment for children and teens. For families that own guns, safe storage 
with gun and ammunition kept locked in separate compartments protects young 
people from unintentional or intentional violence.3 Studies of safe storage 
counseling have yielded mixed results. These interventions tend to focus on gun-
owners, with counseling specifically on safe storage of firearms. There is a dearth of 
randomized-controlled trials on this subject.6 
Everytown for Gun Safety is a group that was founded in the wake of the massacre 
at Sandy Hook Elementary School in order to work for safer gun laws and promote 
safe storage of firearms.  They have created a non-political, non-legislative gun 
safety campaign called “Be SMART” to promote the principles of safe firearm 
practices in the home.7 The campaign focuses on the responsibility of the adult to 
practice firearm safety, rather than asking children to behave responsibly around 
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firearms since this has been proven to be an ineffective strategy.8  It also provides 
counseling for non-firearm-owning families, as it recommends asking about 
unsecured firearms prior to playdates. Thus, it can serve as a simple, universal 
counseling tool for parents who are gun-owning and non-gun-owning. It has not 
been formally evaluated as an educational tool.
Children’s hospitals may be a good place to counsel on firearm safety. Large 
children’s hospitals draw patients from surrounding areas that may include rural, 
suburban, and urban areas. A hospital-based intervention would allow outreach to 
children of all ages. The “free time” patients spend in the hospital, while either 
recovering or waiting for procedures or results, may make patients amenable to 
receiving such counseling.  The inpatient setting has been successfully utilized to 
provide educational interventions to parents of hospitalized children on other 
topics, best studied in the area of smoking cessation.9-12  Walley et al. utilized the 
“Smoking and Kids Don’t Mix” video for parents/caregivers of hospitalized children, 
demonstrating successful reported behavior changes in parents/caregivers to 
reduce second- and third-hand smoke.12 To our knowledge no other study has 
utilized the inpatient setting to address issues related to firearm safety counseling 
and education. 
The primary aim of the study is to determine whether the Be SMART campaign 
delivered to parents in a hospital setting leads to an improvement in knowledge, 
attitudes, and practices about firearm safety. The secondary aim is to determine 
whether the intervention is more effective when delivered with physician face-to-
face counseling in addition to with video and written materials, or with 
standardized video and written materials alone.  
Study Aims:
1) To measure whether parents’ knowledge, attitudes, and practices change 
after a brief educational intervention on gun safety 
2) To measure the knowledge, attitudes, and practices of parents in a tertiary 
care children’s hospital regarding firearm safety practices
3) To compare the efficacy of two methods of delivery of counseling: a video 
alone versus a video plus a physician-delivered intervention
4) To measure whether these changes in practices are sustained one month 
after the intervention
METHODS
Study Design:  This is a randomized controlled 3-arm pre-/post-intervention study 
to investigate the effect of an educational intervention using a Be SMART video and 
written material on parental/legal guardian knowledge, attitudes and practices 
regarding firearm safety.  An additional element of the study design includes a 
randomized controlled trial to investigate any additional effect of a pediatrician-
delivered educational intervention on parental/legal guardian knowledge, attitudes 
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and practices regarding firearm safety. Given that tobacco smoke exposure 
interventions have been previously studied in hospitalized children, we will use a 
video and written materials on tobacco smoke exposure education as our control 
group.12  We will use survey techniques to determine baseline and post-intervention 
knowledge, attitudes and practices regarding firearm safety in parents/legal 
guardians of hospitalized children <20 years old.
Study population:  Parents/legal guardians of children <20 years old hospitalized at 
CHAM.
Inclusion criteria: All parents/legal guardians of children <20 years old hospitalized 
at CHAM who reside with the child.
Exclusion criteria: Previously enrolled in the study, parent/legal guardian preferred 
language other than English or Spanish, hospitalized in the Pediatric Intensive Care 
Unit/critically ill child, or parent/legal guardian acutely distressed.
Study procedure: Daily, residents on the primary medical team will ask the 
parents/legal guardians of new patients or parents/legal guardians not previously 
enrolled in the study if they would allow research personnel to speak with them 
about the study.  If the parent/guardian allows, study personnel will then attempt to 
approach all parents/legal guardians of children <20 years old using the attached 
“Research Personnel Script” and the “Eligibility Form” to assess eligibility. If eligible 
for the study, the participant will then be approached for informed consent.  If they 
consent, study personnel will conduct a standardized verbally-administered “Initial 
Parent/Guardian Survey”.  Once the survey is complete, the participant will be 
randomized to one of 3 study groups: 1. Be SMART alone group: To view the Be 
SMART video and to receive Be SMART written material alone, 2. Be SMART + MD 
group: To view the Be SMART video and to receive Be SMART written material and 
subsequent standardized reinforcement/review with a pediatrician using the “MD 
Checklist for Intervention Review” or 3. Control Group: To view the “Kids and 
Smoke Don’t Mix”12 and to receive written materials from the New York State 
Smokers Quitline.  Study participants will be randomized in blocks of 15 by 
www.randomization.com.  For patients in the “Be SMART+MD” group, each 
physician will verbally review all 5 elements of Be SMART in person with the 
participants, as denoted in the attached checklist.  
Following the intervention, study personnel will conduct a brief verbally 
administered “Post-intervention Parent/Guardian Survey”.  One month later, study 
personnel will conduct the “One Month Follow-up Parent/Guardian Survey” verbally 
administered via telephone. 
Survey Instruments: See attached surveys:
1. Inpatient Firearms Study—Eligibility Form
2. Inpatient Firearms Study—Initial Parent/Guardian Survey
3. Inpatient Firearms Study—Post-intervention Parent/Guardian Survey
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4. Inpatient Firearms Study—One Month Follow-up Parent/Guardian Survey
5. Inpatient Firearms Study—Research Personnel Script
The questions in all of the Parent/Guardian surveys (Initial, Post-
intervention and One Month Follow-up) were all adapted from prior 
published studies which used surveys addressing the topic of youth firearm 
exposure and safety, 13-17 and the control tobacco exposure questions 
adapted from other published studies on tobacco smoke exposure in 
children. 12
Intervention Checklist: See attached—Inpatient Firearms Study—MD Checklist for 
Intervention Review. 
Outcomes:
The primary outcome is the change in parent/legal guardian’s behavior over the 
past 30 days with respect to how often they asked whether or not there are guns in 
the home when their child/children goes to play in another’s person’s home, as 
indicated by a Likert scale assignment of an ordinal value (1-5, 1= never, 2=rarely, 
3=sometimes, 4=most of the time, 5=always).  
Secondary outcomes will include:

Change in the primary outcome (intention to ask noted above) between the 
intervention groups (Be SMARTalone vs. Be SMART + MD)

Demographic factors associated with primary outcome

Description of general knowledge on firearm safety of parents/legal 
guardians of patients in our community 

Description of attitudes about firearm safety of parents/legal guardians of 
patients in our community 

Description of general practices regarding firearm safety of parents/legal 
guardians of patients in our community 

Description of parents attitudes regarding physicians discussing firearm 
safety with them
Data Analysis:
The main objective of the data analysis is to assess within each intervention 
group whether the general parental practice of asking about firearms in the homes 
of others when their children go to play is increased after the intervention.  A 
secondary objective is to perform a head-to-head comparison of the magnitude of 
the intervention effects between the groups.  Our pilot data revealed the proportion 
of the population who either “always” or “most of the time” ask about firearms in 
the homes of others when their children went to play was 50%.  With a sample size 
of 60 subjects in the Be SMART alone group, the study will have 80% power using 
the McNemar’s test with a two-sided alpha=0.05 level to detect an absolute increase 
of 20% between the pre-intervention and post-intervention responses (i.e. raising 
the proportion of those who either “most of the time” or “always” ask about firearms 
in the homes of others when their children went to play from 50% to 70%). For the 
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Be SMART + MD group, we expect the pre- post intervention effect to be larger, i.e., 
increase from 50% before the intervention to 80% after the intervention in the 
proportion of the population who either “most of the time” or “always” asked about 
firearms. With a sample size of 60 subjects in the Be SMART + MD group , the study 
will have greater than 95% power to detect this difference using the McNemar’s test 
with a two-sided alpha=0.05 level.  We expect minimal change in the pre- and post-
survey responses in the control group. For the comparisons between treatment 
arms, we will focus on the subset of parents who initially responded that they were 
not likely to ask about firearms before the intervention (expected to be ~ 50% of 
parents) and assess whether the proportion who changed their response to “most of 
the time” or “always” after the intervention is greater in those who were in either of 
the Be SMART groups compared to the control group.  With 60 subjects in each of 
the 3 study groups, the study will have 80% power to detect an increase in this 
proportion from 10% in the control group (which is a conservative assumption) to 
40% in either the Be SMART alone or Be SMART + MD group using a two-sample 
test of proportions and a two-sided alpha=0.05 level.
We anticipate the majority of the subjects enrolled will complete the 
inpatient portion of the study, however, we estimate up to 20% will not be able to 
be reached by phone for the 30 day follow up call.  Therefore given that our primary 
outcome is based on behavior assessed at the 30 day follow up phone call, we will 
add to each study group 15 patients to give each study group at total of 75 patients, 
and the overall study population will be 225 patients. 
For within-group data analysis, we will use standard descriptive statistics to 
summarize the data and McNemar’s test or the paired T- test to assess the 
significance of pre-post intervention differences in binary and continuous outcomes, 
respectively.  In secondary analysis, we will analyze the parents who responded 
before the intervention: “rarely”, “never”,  or “sometimes” to ask about firearms in 
the homes of others when their children went to play groups and compare across 
interventions the proportion who changed their response to “most of the time” or 
“always” after the intervention using the chi-square or Fisher’s exact test.  We will 
also use logistic regression models to analyze factors associated with the likelihood 
to ask about firearms in the homes of others when children go to play.
Informed Consent:
Parents of hospitalized children will be approached for written informed consent on 
the inpatient service by trained research personnel.  Our form asks for consent to 
participate in the pre-intervention and post-intervention surveys, and to participate 
in the educational intervention, including randomization to one of the three study 
groups (Be SMART alone, Be SMART+ MD discussion, or the control group).  
Additionally the consent asks for permission to collect phone numbers in order to 
contact the parent/legal guardian one month later for a follow up survey. If consent 
is granted, a brief questionnaire will be administered followed by the intervention 
and very brief follow up survey. 
Risks: 
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We do not anticipate any risks to the participants. Any information obtained that 
would permit identification of a participant, it will be held strictly confidential, will 
be used only for the purpose of this study, and will not be disclosed or released to 
others. 
Benefits:
This study will examine knowledge, attitudes, and practices of parents/legal 
guardians regarding firearm safety and tobacco smoke exposure.  While there may 
be no direct benefits to the participants themselves, through the educational 
intervention, they may increase their knowledge regarding gun safety and tobacco 
smoke exposure, particularly related to children, and may decide to change some of 
their own practices related to either or both firearm safety issues and tobacco 
smoke exposure and their children.
Privacy:
All parents/legal guardians will be assigned a study subject number.  There will be 
no linkage of the study subject number to the hospitalized patient. A record will be 
kept with the study subject number to the parent/guardian name and phone 
number for the purpose of a follow up phone call, however, this information will be 
kept in a locked office in a locked cabinet accessible only to research staff.  To 
maximize data integrity, privacy and confidentiality, all digital data related to this 
study will be kept secure on a password-protected computer, in a locked office.  All 
hardcopies related to this protocol will also be kept in a locked office.  All documents 
related to this study will be destroyed when the study is completed.
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IRB APPROVAL DATE: 01/20/2017

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IRB NUMBER: 2016-6918
IRB APPROVAL DATE: 01/20/2017