Pediatric Inpatient Firearm Safety Study

NCT ID: NCT03077646

Last Updated: 2021-02-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-08-09

Brief Summary

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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

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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

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Firearm Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Be SMART

Intervention Type BEHAVIORAL

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

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).

Group Type EXPERIMENTAL

Be SMART + MD review

Intervention Type BEHAVIORAL

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.

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).

Group Type ACTIVE_COMPARATOR

Control: TSE

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Everytown for Gun Safety

OTHER_GOV

Sponsor Role collaborator

Consano Clinical Research, LLC

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Alyssa Silver

Assistant Professor of Pediatrics, Attending Physician Pediatric Hospital Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alyssa H Silver, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35112128 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34162699 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-6918

Identifier Type: -

Identifier Source: org_study_id

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