Randomized Trial to Improve Safe Firearm Storage

NCT05568901 | Completed

• 1 other identifier: 2020-0828
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the effect of providing gun locks to caregivers of children presenting to the emergency department for mental health concerns. The main question it aims to answer is: • Does the provision of gun locks result in higher rates of securement of all household firearms? Participants will be randomized to receive either lethal means counseling (including summary handout) by study team with the provision of 2 cable-style gun locks or lethal means counseling by study team alone (without provision of gun locks). Researchers will compare the lethal means counseling with 2 gun locks group to the lethal means counseling alone group to see if it affects self-reported securement of all household firearms, 4 weeks post emergency department encounter.

Conditions

Firearm Injury; Pediatric Emergency Medicine; Suicide and Self-harm; Mental Health Issue

Keywords

Suicide prevention; Pediatric; Firearm safety

Outcome Measures

Primary Outcomes (1)

• Firearm securement

  Self-reported securement of all household firearms with locking device

  4 weeks post-encounter

Secondary Outcomes (8)

• Caregiver favorability

  4 weeks post-encounter

• Medication securement

  4 weeks post-encounter

• Firearm removal

  4 weeks post-encounter

• Medication removal

  4 weeks post-encounter

• Additional devices

  4 weeks post-encounter

Study Arms (2)

LMC Alone

ACTIVE COMPARATOR

Caregivers who received standardized lethal means counseling (LMC) from the study team as well as a 1-page handout summarizing the counseling recommendations

Behavioral: Lethal means counseling

LMC + Gun Locks

EXPERIMENTAL

Caregivers who received standardized lethal means counseling (LMC) from the study team, 1-page handout summarizing the counseling recommendations, as well as the additional provision of 2 cable-style gun locks

Behavioral: Lethal means counseling; Behavioral: Provision of Cable-style gun locks

Interventions

Lethal means counseling BEHAVIORAL

Lethal means counseling is a type of safety education that advises securement or removal of potentially hazardous household items such as medications, knives, and firearms. Counseling provided by study team was derived from the Suicide Prevention Resource Center's "Counseling on Access to Lethal Means" training module and the "Store It Safe" campaign from the Ohio Chapter of the American Academy of Pediatrics (AAP). Guidance focused on securement of dangerous items in the household, such as medications and firearms, with locking devices-or more preferably removing these items from the home, even if temporarily.

LMC + Gun Locks; LMC Alone

Provision of Cable-style gun locks BEHAVIORAL

Caregivers were provided 2 (two) SnapSafe Cable Padlock (Item No. 75281), advised on how to use these devices to store firearms safely (including instructions from within the package of the provided gun locks) and were advised to store keys away from the firearm in a location that children would not have access

LMC + Gun Locks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver of pediatric patient presenting to the emergency department for mental health evaluation
• Caregiver endorses firearms within the home

You may not qualify if:

• Caregiver not present
• Caregiver is not able to complete survey in written English
• Caregiver unable to be approached due to unsafe conditions as determined by study team and behavioral safety specialists

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Ohio Injury Prevention Partnership: collaborator
• Whitney Strong Organization: collaborator

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Related Publications (20)

• Web-based Injury Statistics Query and Reporting System (WISQARS). National Center for Health Statistics (NCHS). 2022. www.cdc.gov/injury/wisqars

  BACKGROUND

• Miller M, Azrael D, Hemenway D. The epidemiology of case fatality rates for suicide in the northeast. Ann Emerg Med. 2004 Jun;43(6):723-30. doi: 10.1016/j.annemergmed.2004.01.018.

  PMID: 15159703 BACKGROUND

• Grossman DC, Mueller BA, Riedy C, Dowd MD, Villaveces A, Prodzinski J, Nakagawara J, Howard J, Thiersch N, Harruff R. Gun storage practices and risk of youth suicide and unintentional firearm injuries. JAMA. 2005 Feb 9;293(6):707-14. doi: 10.1001/jama.293.6.707.

  PMID: 15701912 BACKGROUND

• Beidas RS, Rivara F, Rowhani-Rahbar A. Safe Firearm Storage: A Call for Research Informed by Firearm Stakeholders. Pediatrics. 2020 Nov;146(5):e20200716. doi: 10.1542/peds.2020-0716. Epub 2020 Oct 9. No abstract available.

  PMID: 33037120 BACKGROUND

• Azrael D, Cohen J, Salhi C, Miller M. Firearm Storage in Gun-Owning Households with Children: Results of a 2015 National Survey. J Urban Health. 2018 Jun;95(3):295-304. doi: 10.1007/s11524-018-0261-7.

  PMID: 29748766 BACKGROUND

• Johnson RM, Barber C, Azrael D, Clark DE, Hemenway D. Who are the owners of firearms used in adolescent suicides? Suicide Life Threat Behav. 2010 Dec;40(6):609-11. doi: 10.1521/suli.2010.40.6.609.

  PMID: 21198329 BACKGROUND

• Monuteaux MC, Azrael D, Miller M. Association of Increased Safe Household Firearm Storage With Firearm Suicide and Unintentional Death Among US Youths. JAMA Pediatr. 2019 Jul 1;173(7):657-662. doi: 10.1001/jamapediatrics.2019.1078.

  PMID: 31081861 BACKGROUND

• Kalb LG, Stapp EK, Ballard ED, Holingue C, Keefer A, Riley A. Trends in Psychiatric Emergency Department Visits Among Youth and Young Adults in the US. Pediatrics. 2019 Apr;143(4):e20182192. doi: 10.1542/peds.2018-2192. Epub 2019 Mar 18.

  PMID: 30886112 BACKGROUND

• Barkin SL, Finch SA, Ip EH, Scheindlin B, Craig JA, Steffes J, Weiley V, Slora E, Altman D, Wasserman RC. Is office-based counseling about media use, timeouts, and firearm storage effective? Results from a cluster-randomized, controlled trial. Pediatrics. 2008 Jul;122(1):e15-25. doi: 10.1542/peds.2007-2611.

  PMID: 18595960 BACKGROUND

• Albright TL, Burge SK. Improving firearm storage habits: impact of brief office counseling by family physicians. J Am Board Fam Pract. 2003 Jan-Feb;16(1):40-6. doi: 10.3122/jabfm.16.1.40.

  PMID: 12583649 BACKGROUND

• Gittelman MA, Pomerantz WJ, Laurence S. An emergency department intervention to increase booster seat use for lower socioeconomic families. Acad Emerg Med. 2006 Apr;13(4):396-400. doi: 10.1197/j.aem.2005.11.002. Epub 2006 Mar 10.

  PMID: 16531596 BACKGROUND

• Runyan CW, Becker A, Brandspigel S, Barber C, Trudeau A, Novins D. Lethal Means Counseling for Parents of Youth Seeking Emergency Care for Suicidality. West J Emerg Med. 2016 Jan;17(1):8-14. doi: 10.5811/westjem.2015.11.28590. Epub 2016 Jan 12.

  PMID: 26823923 BACKGROUND

• Uspal NG, Strelitz B, Cappetto K, Tsogoo A, Jensen J, Rutman LE, Schloredt K, Bradford MC, Bennett E, Paris CA. Impact of a Firearm Safety Device Distribution Intervention on Storage Practices After an Emergent Mental Health Visit. Acad Pediatr. 2021 Sep-Oct;21(7):1209-1217. doi: 10.1016/j.acap.2021.04.024. Epub 2021 May 1.

  PMID: 33945885 BACKGROUND

• Carbone PS, Clemens CJ, Ball TM. Effectiveness of gun-safety counseling and a gun lock giveaway in a Hispanic community. Arch Pediatr Adolesc Med. 2005 Nov;159(11):1049-54. doi: 10.1001/archpedi.159.11.1049.

  PMID: 16275796 BACKGROUND

• Posner JC, Hawkins LA, Garcia-Espana F, Durbin DR. A randomized, clinical trial of a home safety intervention based in an emergency department setting. Pediatrics. 2004 Jun;113(6):1603-8. doi: 10.1542/peds.113.6.1603.

  PMID: 15173480 BACKGROUND

• Rowhani-Rahbar A, Simonetti JA, Rivara FP. Effectiveness of Interventions to Promote Safe Firearm Storage. Epidemiol Rev. 2016;38(1):111-24. doi: 10.1093/epirev/mxv006. Epub 2016 Jan 13.

  PMID: 26769724 BACKGROUND

• Sheatsley PB. Handbook of Survey Research. In: Rossi PH, ed. Handbook of Survey Research. Academic Press; 1983:chap Chapter 6: Questionnaire Construction and Item Writing.

  BACKGROUND

• Ruch DA, Steelesmith DL, Warner LA, Bridge JA, Campo JV, Fontanella CA. Health Services Use by Children in the Welfare System Who Died by Suicide. Pediatrics. 2021 Apr;147(4):e2020011585. doi: 10.1542/peds.2020-011585. Epub 2021 Mar 8.

  PMID: 33685986 BACKGROUND

• Ketabchi B, Gittelman MA, Southworth H, Arnold MW, Denny SA, Pomerantz WJ. Attitudes and perceived barriers to firearm safety anticipatory guidance by pediatricians: a statewide perspective. Inj Epidemiol. 2021 Sep 13;8(Suppl 1):21. doi: 10.1186/s40621-021-00319-9.

  PMID: 34517906 BACKGROUND

• Ketabchi B, Gittelman MA, Zhang Y, Pomerantz WJ. Impact of cable lock distribution on firearm securement after emergent mental health evaluation: a randomized controlled trial. Inj Epidemiol. 2024 Nov 11;11(Suppl 1):63. doi: 10.1186/s40621-024-00541-1.

  PMID: 39529188 DERIVED

Related Links

• Suicide prevention resource center's online "Counseling on access to lethal means" training module that was used to help develop lethal means counseling provided in the study
• Ohio Chapter of the American Academy of Pediatrics "Store it safe" campaign that was used to help develop lethal means counseling provided in the study

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior; Suicide Prevention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: June 28, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)