Pediatric Inpatient Firearm Safety Study
IF
1 other identifier
interventional
225
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2019
CompletedResults Posted
Study results publicly available
February 23, 2021
CompletedFebruary 23, 2021
February 1, 2021
2.4 years
January 31, 2017
July 17, 2020
February 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention
1 month after intervention
Study Arms (3)
Be SMART alone
EXPERIMENTALParents/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
EXPERIMENTALParents/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 COMPARATORParents/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).
Interventions
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
A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line.
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.
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- Everytown for Gun Safetycollaborator
- Consano Clinical Research, LLCcollaborator
Study Sites (1)
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Related Publications (2)
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.
PMID: 35112128DERIVEDSilver 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.
PMID: 34162699DERIVED
Limitations and Caveats
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.
Results Point of Contact
- Title
- Alyssa Silver, MD
- Organization
- Children's Hospital at Montefiore
Study Officials
- PRINCIPAL INVESTIGATOR
Alyssa H Silver, MD
Children's Hospital at Montefiore-Department of Pediatrics, Division of Hospital Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics, Attending Physician Pediatric Hospital Medicine
Study Record Dates
First Submitted
January 31, 2017
First Posted
March 13, 2017
Study Start
March 1, 2017
Primary Completion
August 9, 2019
Study Completion
August 9, 2019
Last Updated
February 23, 2021
Results First Posted
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
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.