Pediatric Inpatient Firearm Safety Study (IF)

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.

Study Overview

• Status: Completed
• Conditions: Firearm Safety
• Intervention / Treatment: Behavioral: Be SMART; Behavioral: Be SMART + MD review; Behavioral: Control: TSE

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

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Experimental: 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).	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.
Active Comparator: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and last 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month after intervention

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Consano Clinical Research, LLC; Everytown for Gun Safety
• Investigators: Principal Investigator: Alyssa H Silver, MD, Children's Hospital at Montefiore-Department of Pediatrics, Division of Hospital Medicine

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 9, 2019
• Study Completion (Actual): August 9, 2019

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: safety; pediatric; gun; inpatient; firearm
• Other Study ID Numbers: 2016-6918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No