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Pediatric Inpatient Firearm Safety Study

Pediatric Inpatient Firearm Safety Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077646
Acronym
IF
Enrollment
225
Registered
2017-03-13
Start date
2017-03-01
Completion date
2019-08-09
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Firearm Safety

Keywords

firearm, gun, safety, pediatric, inpatient

Brief summary

There is currently no available data regarding using the inpatient setting as an opportunity to talk to parents/guardians about firearm safety. The investigators will be doing a pre-/post-intervention study to investigate the effect of an intervention (a 5.5 minute Be SMART video and written materials developed by the organization Everytown for Gun Safety), on parental/legal guardian knowledge, attitudes and practices regarding firearm safety. While the American Academy of Pediatrics recommends the safest home for children is one without guns, the reality is that there are families with guns in the home. This non-political video focuses on ways to keep children safe from firearms. The investigators will also investigate any additional effect of physician-delivered counseling on parental/guardian knowledge, attitudes and practices regarding gun safety as compared to receiving the information solely via video and written materials. Participants will be randomized to 1 of 3 groups (intervention, intervention + MD discussion and control group). Outcomes will be assessed immediately post intervention and in a 30-day follow up phone call.

Detailed description

Eligibility: All parents/guardians of inpatients admitted to the Children's Hospital at Montefiore. Exclusion: Parents/guardians whose children are in acute distress or in the Pediatric Intensive Care Unit. 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

Interventions

BEHAVIORALBe SMART

An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART

BEHAVIORALControl: TSE

A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line.

BEHAVIORALBe SMART + MD review

An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician.

Sponsors

Everytown for Gun Safety
CollaboratorOTHER_GOV
Consano Clinical Research, LLC
CollaboratorOTHER
Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

\-

Exclusion criteria

* parents/guardians whose child is hospitalized in the Pediatric Intensive Care Unit * parents/guardians whose child is in acute distress * parents/guardians who have previously been in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-interventionBaseline and last 30 daysThe primary outcome is within each group the change in how often the parent/guardian asked whether there are guns in the home when the child went to another person's home in the last 30 days Likert Scale 1=never, 2=rarely, 3=sometimes, 4=most of the time, 5=always

Secondary

MeasureTime frameDescription
Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention1 month after interventionLikert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree

Countries

United States

Participant flow

Recruitment details

This study examine knowledge, attitudes, and practices of parents/legal guardians regarding firearm safety and tobacco smoke exposure. Children were not enrolled.

Pre-assignment details

The parent/guardian only was enrolled (child was not), therefore it is not a dyad.

Participants by arm

ArmCount
Be SMART Alone
Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information. Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART
76
Be SMART + MD Review
Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review). Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician.
75
Control: TSE Materials
Parents/guardians in this study group will watch a video Kids and Smoke Don't Mix and receive handouts reviewing information on tobacco smoke exposure (TSE). Control: TSE: A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line.
74
Total225

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up293031

Baseline characteristics

CharacteristicBe SMART + MD ReviewControl: TSE MaterialsTotalBe SMART Alone
Age, Continuous35.0 years32.0 years33.0 years34.0 years
Been shot with a gun?1 Participants1 Participants3 Participants1 Participants
Been threatened with a gun?8 Participants7 Participants21 Participants6 Participants
Child age (years), median (IQR)6.0 years4.0 years5.0 years4.5 years
Child gender
Female
26 Participants40 Participants109 Participants43 Participants
Child gender
Male
48 Participants34 Participants115 Participants33 Participants
Child gender
Missing
1 Participants0 Participants1 Participants0 Participants
Child has seen a gun?6 Participants4 Participants15 Participants5 Participants
Child has touched a gun?3 Participants2 Participants7 Participants2 Participants
Child's doctor has ever talked about gun safety9 Participants4 Participants18 Participants5 Participants
Discussed with child what to do if they find a gun?17 Participants17 Participants53 Participants19 Participants
Discussed with other children what do do if they find a gun?23 Participants22 Participants66 Participants21 Participants
For those who don't have a gun, you would feel safer if you had a gun7 Participants4 Participants18 Participants7 Participants
Friend or relative has a gun?20 Participants18 Participants59 Participants21 Participants
Guns have been brought into your home by guests7 Participants5 Participants19 Participants7 Participants
Have a friend/relative shot with a gun?27 Participants28 Participants94 Participants39 Participants
Have a gun in your home2 Participants2 Participants8 Participants4 Participants
Heard gunshots in your neighborhood42 Participants42 Participants135 Participants51 Participants
Insurance
Medicaid
49 Participants55 Participants150 Participants46 Participants
Insurance
Missing
3 Participants2 Participants5 Participants0 Participants
Insurance
None
0 Participants2 Participants4 Participants2 Participants
Insurance
Other
1 Participants0 Participants3 Participants2 Participants
Insurance
Private
22 Participants15 Participants63 Participants26 Participants
It is important to ask about guns in others' homes when your child goes there4.3 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 1
4.4 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 1
4.3 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 0.7
4.4 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 1
Language
English
67 Participants71 Participants211 Participants73 Participants
Language
Mixed English & Spanish
2 Participants0 Participants2 Participants0 Participants
Language
Spanish
6 Participants3 Participants12 Participants3 Participants
Parental education
College
27 Participants23 Participants78 Participants28 Participants
Parental education
Elementary school
2 Participants2 Participants5 Participants1 Participants
Parental education
Graduate school
8 Participants5 Participants18 Participants5 Participants
Parental education
High School
32 Participants36 Participants102 Participants34 Participants
Parental education
Some High school
6 Participants8 Participants22 Participants8 Participants
Race/Ethnicity, Customized
Child Race/ethnicity
Hispanic
42 Participants45 Participants126 Participants39 Participants
Race/Ethnicity, Customized
Child Race/ethnicity
Non-Hispanic Black
19 Participants20 Participants68 Participants29 Participants
Race/Ethnicity, Customized
Child Race/ethnicity
Non-Hispanic White
3 Participants5 Participants10 Participants2 Participants
Race/Ethnicity, Customized
Child Race/ethnicity
Other
11 Participants4 Participants21 Participants6 Participants
Raised in a home with a gun?8 Participants2 Participants14 Participants4 Participants
Seen a person with a gun?24 Participants18 Participants65 Participants23 Participants
Sex: Female, Male
Female
66 Participants65 Participants196 Participants65 Participants
Sex: Female, Male
Male
9 Participants9 Participants29 Participants11 Participants
Worry your child would play with a gun if they find one41 Participants42 Participants128 Participants45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 760 / 750 / 74
other
Total, other adverse events
0 / 760 / 750 / 74
serious
Total, serious adverse events
0 / 760 / 750 / 74

Outcome results

Primary

Change in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-intervention

The primary outcome is within each group the change in how often the parent/guardian asked whether there are guns in the home when the child went to another person's home in the last 30 days Likert Scale 1=never, 2=rarely, 3=sometimes, 4=most of the time, 5=always

Time frame: Baseline and last 30 days

Population: Limited sample for analysis to paired samples within each group (samples where we have responses from the same study subject pre and post)

ArmMeasureValue (MEAN)Dispersion
Be SMART AloneChange in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-intervention0.8 score on a scaleStandard Deviation 1.7
Be SMART + MD ReviewChange in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-intervention0.6 score on a scaleStandard Deviation 1.3
Control: TSE MaterialsChange in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-intervention0.9 score on a scaleStandard Deviation 1.4
Secondary

Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention

Likert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree

Time frame: 1 month after intervention

Population: Some parents unable to reach by phone at 1 month

ArmMeasureValue (MEAN)Dispersion
Be SMART AloneDoctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention4.2 score on a scaleStandard Deviation 0.9
Be SMART + MD ReviewDoctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention4.3 score on a scaleStandard Deviation 0.8
Control: TSE MaterialsDoctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention4.3 score on a scaleStandard Deviation 0.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026