Reframing Firearm Injury Prevention Through Bystander Interventions for Youth

NCT04804189 | Completed

• 1 other identifier: R01CE003267
• Study Type: interventional
• Target: 801
• Locations: 1 country
• Sites: 1

Brief Summary

Modifiable risk factors for youth firearm injury and death include unsafe storage of a firearm in the home, prior victimization/aggression, substance use, and depressive symptoms, yet there are few partnerships with firearm owners and firearm safety training programs to implement effective, non-policy-based preventive interventions for youth firearm injury. This study will conduct a hybrid effectiveness-implementation trial to evaluate the effectiveness of Guardians 4 Health, a bystander intervention designed to promote changes in firearm injury prevention norms, attitudes, intentions, and behaviors among a sample up to 60 4-H Shooting Sports Club communities comprising both adults and youth. This project is designed to build the evidence base for interventions that promote safe behaviors related to youth firearm use and injury prevention and advance firearm injury prevention science by supporting a synergistic partnership between well-established firearm injury, suicide, and violence prevention researchers and the national 4-H Shooting Sports community.

Conditions

Firearm Injury

Keywords

firearm injury prevention; bystander intervention; youth violence prevention; shooting sports; firearm safety

Outcome Measures

Primary Outcomes (1)

• Change in Intention to Use Behavioral Intervention Skills via Cook-Craig et al 2014

  We will measure intention to intervene to prevent firearm injury using a scale adapted from Cook-Craig et al 2014. Scale title: Adapted Theory of Planned Behavior Scale Minimum value: 1 Maximum value: 5 Higher score (adjusted for reverse coding) indicates a better outcome. Due to under-enrollment, the study team decided to have this outcome as the SINGLE primary outcome in September 2024, before any data analysis began.

  0, 3 and 6 months

Secondary Outcomes (8)

• Feasibility of Intervention via Percent of Intervention Activities Completed

  3 and 6 months

• Change in Perceived Behavioral Control via Adapted Theory of Planned Behavior Scale

  0, 3 and 6 months

• Change in Subjective Norms via Adapted Theory of Planned Behavior Scale

  0, 3 and 6 months

• Change in Attitudes via Adapted Theory of Planned Behavior Scale

  0, 3 and 6 months

• Change in Knowledge of Firearm Injuries in the US

  0, 3 and 6 months

Other Outcomes (1)

• Change in Use of Behavioral Intervention Skills via Cook-Craig et al 2014

  0, 3, and 6 months

Study Arms (2)

Control Group

NO INTERVENTION

Up to 30 4-H Shooting Sport Clubs that will not receive Guardians 4 Health intervention.

Intervention Group

EXPERIMENTAL

Up to 30 Randomized 4-H Shooting Sport Clubs that will receive Guardians 4 Health intervention.

Behavioral: Guardians 4 Health

Interventions

Guardians 4 Health BEHAVIORAL

Clubs will implement Guardians 4 Health's intervention into their community by incorporating Guardians 4 Health materials into standard Club educational activities.

Intervention Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Membership of child participant in local 4-H Shooting Sports Club OR
• Parent of a child participant in local 4-H Shooting Sports Club OR
• Community member of a participating local 4-H Shooting Sports Club

You may not qualify if:

• Non-English speakers
• Unable to consent or assent

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Brown University: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

• Cook-Craig PG, Coker AL, Clear ER, Garcia LS, Bush HM, Brancato CJ, Williams CM, Fisher BS. Challenge and opportunity in evaluating a diffusion-based active bystanding prevention program: Green Dot in high schools. Violence Against Women. 2014 Oct;20(10):1179-202. doi: 10.1177/1077801214551288. Epub 2014 Sep 24.

  PMID: 25255794 BACKGROUND

• Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50(2):179-211.

  BACKGROUND

• Trinka T, Oesterle DW, Silverman AC, Vriniotis MG, Orchowski LM, Beidas RS, Betz ME, Hudson C, Kesner T, Ranney ML. Bystander intervention to prevent firearm injury: A qualitative study of 4-H shooting sports participants. J Community Psychol. 2023 Sep;51(7):2652-2666. doi: 10.1002/jcop.23069. Epub 2023 Jun 9.

  PMID: 37294273 RESULT

Study Officials

• Nicole Nugent, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Model Details: We will enroll up to 60 4-H Shooting Sports communities nationwide to participate in a Type I Hybrid Effectiveness Trial. All Clubs will receive standard national-level training and curricula. Clubs randomized to "Guardians 4 Health" intervention will add additional training to enable Club Leaders to integrate Guardians 4 Health methods into their standard activities. We will provide ongoing technical support to all intervention Clubs. In all enrolled communities, we will measure 1) short- and intermediate-term outcomes among both Club-level adult and teen leaders and the Club's youth participants and their primary caregivers, and 2) injury incidence.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 18, 2021
• Study Start: September 1, 2021
• Primary Completion: September 15, 2024
• Study Completion: August 29, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Within 30 months of completing data collection.
• Access Criteria: Data files deposited into ICPSR receive a Digital Object Identifier (DOI), which the Investigators will cite and include in all publications for the public and other researchers to locate and access the data. The Investigators will comply with the CDC Public Access Policy and upon acceptance deposit the final peer-reviewed manuscript of publications in PubMed Central (PMC), CDC Stacks, and Investigators' institutional repositories for free and public access.

Locations

US (1)