Firearm SafetyIFNCT03077646

Pediatric Inpatient Firearm Safety Study

A study testing Be SMART and Be SMART + MD review in people with Firearm Safety, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Firearm Safety
What is being tested?: Be SMART and Be SMART + MD review
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2017to 9 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital at Montefiore
The Bronx, New York, 10467

Other trials in United States

About this study

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.

Read the 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

Conditions: Firearm Safety
Being tested: Be SMART, Control: TSE, Be SMART + MD review
Keywords: firearm, gun, safety, pediatric, inpatient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Be SMARTBehavioural
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
Control: TSEBehavioural
A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line.
Be SMART + MD reviewBehavioural
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.

Study groups in NCT03077646
Study group	Role	What they receive
Be SMART alone	Experimental	Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information. Receives: Behavioral: Be SMART
Be SMART + MD review	Experimental	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). Receives: Behavioral: Be SMART + MD review
Control: TSE materials	Active comparator	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). Receives: Behavioral: Control: TSE

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and last 30 days

Secondary outcomes (1)

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
Measured: 1 month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20179 Aug 2019

First posted13 Mar 2017
Study start1 Mar 2017
Primary completion9 Aug 2019
Study completion9 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Firearm SafetyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03077646
Sponsor's protocol ID: 2016-6918
Acronym: IF
Status last verified: Feb 2021
First submitted: 31 Jan 2017
Last updated: 23 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to share individual participant data with other researchers. The data will only be available to study personnel approved on this study.

Publications

Silver AH, Curley M, Azzarone G, Dodson N, O'Connor K. A Parent Survey Assessing Association of Exposure to Gun Violence, Beliefs, and Physician Counseling. Hosp Pediatr. 2022 Mar 1;12(3):e95-e111. doi: 10.1542/hpeds.2021-006050.
PubMed 35112128
Silver AH, Azzarone G, Dodson N, Curley M, Eisenberg R, Kim M, O'Connor K. A Randomized Controlled Trial for Parents of Hospitalized Children: Keeping Kids Safe From Guns. Hosp Pediatr. 2021 Jul;11(7):691-702. doi: 10.1542/hpeds.2020-001214. Epub 2021 Jun 23.
PubMed 34162699

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Firearm Secure Storage Device Distribution RCT
Firearm Safety, Firearm Safety Storage
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
Not yet recruiting
Leveraging Video Vignettes and Social Media to Promote Safe Firearm Storage Among Veterans
Lethal Means Safety
Not yet recruiting
Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide
Lethal Means Safety, Brief Intervention
Recruiting
BeSMART Secure Storage Counseling in the Inpatient Setting
Firearm Injury, Safety Issues

All Firearm Safety trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pediatric Inpatient Firearm Safety Study
ClinicalTrials.gov ID: NCT03077646
Acronym / sponsor ID: IF / 2016-6918
Conditions: Firearm Safety
Keywords: firearm, gun, safety, pediatric, inpatient
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Collaborators: Everytown for Gun Safety, Consano Clinical Research, LLC
Study start: 1 Mar 2017 (actual)
Primary completion: 9 Aug 2019 (actual)
Study completion: 9 Aug 2019 (actual)
First posted: 13 Mar 2017 (actual)
Results: Posted 23 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Be SMART alone	Experimental	Behavioral: Be SMARTParents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information.
Be SMART + MD review	Experimental	Behavioral: Be SMART + MD reviewParents/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).
Control: TSE materials	Active comparator	Behavioral: Control: TSEParents/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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Be SMARTAn 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	Behavioural	Be SMART alone
Control: TSEA video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line.	Behavioural	Control: TSE materials
Be SMART + MD reviewAn 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.	Behavioural	Be SMART + MD review

Primary outcome

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
Time frame: Baseline and last 30 days
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

1 secondary outcome

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

Results and safety

Results posted to the registry on 23 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Be SMART Alone	76	47
Be SMART + MD Review	75	45
Control: TSE Materials	74	43

Primary outcome: 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

Time frame: Baseline and last 30 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Be SMART Alone n = 25	Be SMART + MD Review n = 27	Control: TSE Materials n = 20
Value	0.8 (1.7)	0.6 (1.3)	0.9 (1.4)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: One month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Be SMART Alone	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Be SMART + MD Review	0 of 75 (0%)	0 of 75 (0%)	0 of 75
Control: TSE Materials	0 of 74 (0%)	0 of 74 (0%)	0 of 74

Limitations and caveats (from the sponsor): Single center with particular "gun culture" may not be generalizable to other regions of the country. Limited paired sample follow-up, therefore may be underpowered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35112128Silver AH, Curley M, Azzarone G, Dodson N, O'Connor K. A Parent Survey Assessing Association of Exposure to Gun Violence, Beliefs, and Physician Counseling. Hosp Pediatr. 2022 Mar 1;12(3):e95-e111. doi: 10.1542/hpeds.2021-006050.
Derived from this study: PubMed 34162699Silver AH, Azzarone G, Dodson N, Curley M, Eisenberg R, Kim M, O'Connor K. A Randomized Controlled Trial for Parents of Hospitalized Children: Keeping Kids Safe From Guns. Hosp Pediatr. 2021 Jul;11(7):691-702. doi: 10.1542/hpeds.2020-001214. Epub 2021 Jun 23.
Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers. The data will only be available to study personnel approved on this study.

Related trials for Firearm Safety

Not yet recruiting
Firearm Secure Storage Device Distribution RCT
Firearm Safety, Firearm Safety Storage
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
Not yet recruiting
Leveraging Video Vignettes and Social Media to Promote Safe Firearm Storage Among Veterans
Lethal Means Safety
Not yet recruiting
Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide
Lethal Means Safety, Brief Intervention
Recruiting
BeSMART Secure Storage Counseling in the Inpatient Setting
Firearm Injury, Safety Issues

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alyssa H Silver, MD principal investigator

Children's Hospital at Montefiore-Department of Pediatrics, Division of Hospital Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Be SMART and Be SMART + MD review in people with Firearm Safety, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline and last 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03077646, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.