Reframing Firearm Injury Prevention Through Bystander Interventions for Youth

• ClinicalTrials.gov Identifier: NCT04804189
• Recruitment Status: Recruiting
• First Posted: March 18, 2021
• Last Update Posted: September 29, 2021
• Sponsor: Rhode Island Hospital
• Information provided by (Responsible Party): Megan L. Ranney Md MPH, Rhode Island Hospital

Study Description

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 The Reframe, a bystander intervention designed to promote changes in firearm injury prevention norms, attitudes, intentions, and behaviors among a sample of 50 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.

Condition or disease	Intervention/treatment	Phase
Firearm Injury	Behavioral: The Reframe	Not Applicable

Detailed Description:

Firearm injury and mortality is a major public health concern for American youth age 1-19. Only motor vehicle crashes kill more American youth than firearms. In 2018 alone, 1729 American youth died from firearm injuries (50% firearm homicide, 42% firearm suicide) and over 6500 youth were treated in an emergency department for firearm injury; these injuries have major long-term consequences for youth and their families. Approximately one-third of American youth live in a home with a firearm. Risk factors for youth firearm injury and death, such as unsafe home storage of a firearm, prior victimization/aggression, substance use, and depressive symptoms, can be modified. Community partnerships are essential for developing and enacting effective change in injury risk factors, particularly for youth. Due to the fraught political landscape and lack of research funding, partnerships with firearm owners and firearm safety training programs to create and disseminate effective, non-policy-based preventive interventions for youth firearm injury are lacking.

Bystander intervention (BI) is an intervention framework rooted in social psychological theories such as the Theory of Planned Behavior (TPB), with proven efficacy and effectiveness targeting both individual and community behavior change. "The Reframe" is a three-part, already-piloted intervention that uses the BI framework and TPB mechanisms to promote community norms change about firearm safety, BI, and harm reduction techniques (e.g., safe storage, reducing access to lethal means, conflict resolution). Recognizing that BI is most rigorous when led by credible messengers, The Reframe uses instructional, peer-to-peer, and social-media strategies in conjunction with community organizations that are deeply connected to firearm safety efforts. Pilot data supports The Reframe's acceptability and feasibility in changing firearm owners' norms and behaviors.

The necessary next step in this intervention development is to evaluate its effectiveness using a randomized, controlled study design. Our community partner, the National 4-H Shooting Sports Program, is a national leader and trusted messenger for firearm safety. Across the United States, 20,000 trained adult Club Leaders, 5,000 Teen Ambassadors, and 450,000 youth Shooting Sports participants (age 8-18) learn marksmanship, and safe and responsible use of firearms, through its structured curriculum. Leaders from 4-H are excited to implement and study The Reframe among their Shooting Sports Clubs and communities to reduce youth firearm injury and mortality risk. Our research team will evaluate The Reframe's effectiveness, compared to usual 4-H training, in changing firearm injury prevention norms, attitudes, behavioral intention, and practice among a sample of fifty 4-H Shooting Sports Club communities, via a Type I Hybrid randomized, controlled effectiveness trial. Aims are:

Refinement and Planning (Year 1): Adapt The Reframe for the 4-H Shooting Sports Club context Aim 1: Conduct a series of key informant interviews with an advisory panel of 20 key stakeholders (teen and adult 4-H Shooting Sports leaders representing a diverse group of communities and 4-H experience) to ensure The Reframe addresses 4-H-specific issues of acceptability, feasibility, and appropriateness.

Intervention Delivery (Years 2-3): Conduct a hybrid Type I effectiveness-implementation trial of The Reframe with fifty 4-H Shooting Sports Clubs across the United States. For each intervention Club, we will engage one Adult Site Champion and one Teen Ambassador in a kickoff meeting; provide materials to incorporate into standard 4-H curricula; support community and social-media events; and provide ongoing technical support. Evaluations will be conducted at 0, 3, and 6 months and via social media analytics.

Aim 2A: Evaluate The Reframe's effectiveness, compared to usual training, in changing individual- and community-level, proximal and distal behavioral outcomes related to firearm injury prevention.

Aim 2B: Examine barriers and facilitators to implementation of The Reframe intervention using a mixed-methods (qualitative and quantitative) approach.

Aim 2C: (Exploratory) Explore injury patterns among all 50 communities using population-level data.

The study will advance the science of firearm injury prevention in youth in the context of a real-world partnership between well-established firearm injury, suicide, and violence prevention researchers and the national 4-H Shooting Sports Program to conduct a rigorous experimental evaluation of a promising universal primary prevention program. Our long-term goals, consistent with CDC priorities, are to build an evidence base for best practices for individual- and community-level interventions that are easy to implement; to promote safe behaviors around firearm use and injury prevention, thereby saving lives; to meld best scientific practice with deep community-based expertise; and to create a model that can be scaled across 4-H's network, which reaches nearly 6 million youth across the nation.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 5500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: We will enroll fifty 4-H Shooting Sports Clubs to participate in a Type I Hybrid Effectiveness Trial. All Clubs will receive standard national-level training and curricula. Clubs randomized to "The Reframe" intervention will add additional training to enable Club Leaders to integrate The Reframe 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; (2) reach and tone of conversations on social media; and (3) injury incidence.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Reframing Firearm Injury Prevention Through Bystander Interventions for Youth Shooting Sports Participants
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: September 30, 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Group; 25 4-H Shooting Sport Clubs that will not receive The Reframe intervention.
Experimental: Intervention Group; 25 Randomized 4-H Shooting Sport Clubs that will receive The Reframe intervention.	Behavioral: The Reframe; Clubs will implement The Reframe's intervention into their community by (1) incorporating The Reframe materials into standard Club educational activities; (2) conducting a community- level Reframe event, led by Club adult and teen leaders; and (3) using social norms digital marketing materials.

Outcome Measures

Primary Outcome Measures :

1. Change in Knowledge of Firearm Injuries in the US [ Time Frame: 0, 3 and 6 months ]
   Knowledge of frequency, types, and risk factors for firearm injury will be assessed using a series of true/false questions based on intervention content.
2. Change in Attitudes via Adapted Theory of Planned Behavior Scale [ Time Frame: 0, 3 and 6 months ]

   Attitudes regarding both firearm injury prevention and bystander intervention will be measured using a scale adapted from Azjen's Theory of Planned Behavior (Citation not indexed in PubMed: Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50(2):179-211.)

   Scale title: Adapted Theory of Planned Behavior Scale Minimum value: 1 Maximum value: 5 Higher score (adjusted for reverse coding) indicates a better outcome.

3. Change in Subjective Norms via Adapted Theory of Planned Behavior Scale [ Time Frame: 0, 3 and 6 months ]

   Norms regarding both firearm safety and bystander intervention will be measured using a scale adapted from Azjen's Theory of Planned Behavior (1).

   Scale title: Adapted Theory of Planned Behavior Scale Minimum value: 1 Maximum value: 5 Higher score (adjusted for reverse coding) indicates a better outcome.

4. Change in Perceived Behavioral Control via Adapted Theory of Planned Behavior Scale [ Time Frame: 0, 3 and 6 months ]

   Perceived behavioral control regarding intervention as a bystander will be measured using a scale adapted from Azjen's Theory of Planned Behavior (1).

   Scale title: Adapted Theory of Planned Behavior Scale Minimum value: 1 Maximum value: 5 Higher score (adjusted for reverse coding) indicates a better outcome.

5. Change in Intention to Use Behavioral Intervention Skills via Cook-Craig et al 2014 [ Time Frame: 0, 3 and 6 months ]

   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.

Secondary Outcome Measures :

1. Feasibility of Intervention via Percent of Intervention Activities Completed [ Time Frame: 3 and 6 months ]
   We will use a target of 75% of participants completing intervention activities as a means of assessing intervention feasibility. Standard implementation metrics (e.g., on number of 4-H Club sessions, number of community events, number of participants at each Community event) will also be collected.
2. Acceptability of Intervention via The Ottawa Acceptability Scale [ Time Frame: 3 and 6 months ]
   The Ottawa Acceptability Scale (OAS) measures multiple dimensions of acceptability of an intervention including: length; amount of information; balance in presentation of information; and overall appropriateness for the community. The OAS is a 15-item scale (most with 4-point Likert scale response options) that will be assessed from all enrolled participants (Site Champions, Teen Ambassadors, Club Leaders, youth participants, and primary caregivers) at all time points. We will use a target of 85% of participants rating The Reframe as acceptable (global rating). Standard implementation metrics (e.g., on number of 4-H Club sessions, number of community events, number of participants at each Community event) will also be collected.
3. Barriers to Intervention via Qualitative Interviews Using the Consolidated Framework for Intervention Research [ Time Frame: 3 and 6 months ]
   Measured qualitatively via semi-structured interviews with Site Champions and a purposefully sampled subset of adult Club Leaders, as guided by the Proctor Implementation Outcomes framework. These interviews will be structured using the Consolidated Framework for Intervention Research; we will query around barriers at the level of the intervention, outer setting (national 4-H, surrounding community), inner setting (local Club), and individual (adult leader) level.
4. Facilitators of Intervention via Qualitative Interviews Using the Consolidated Framework for Intervention Research [ Time Frame: 3 and 6 months ]
   Measured qualitatively via semi-structured interviews with Site Champions and a purposefully sampled subset of adult Club Leaders, as guided by the Proctor Implementation Outcomes framework. These interviews will be structured using the Consolidated Framework for Intervention Research; we will query around barriers at the level of the intervention, outer setting (national 4-H, surrounding community), inner setting (local Club), and individual (adult leader) level.

Other Outcome Measures:

1. Change in Use of Behavioral Intervention Skills via Cook-Craig et al 2014 [ Time Frame: 0, 3, and 6 months ]
   This measure will be adapted from a previously validated survey by Cook-Craig et al 2014.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Non-English speakers
• Unable to consent or assent

Contacts and Locations

Contacts

Contact: Mary G Vriniotis, MS; 401-444-2557; mary_vriniotis@brown.edu

Locations

United States, Rhode Island

Rhode Island Hospital; Recruiting

Providence, Rhode Island, United States, 02903

Contact: Megan Ranney

Sponsors and Collaborators

Rhode Island Hospital

Investigators

• Principal Investigator: Megan L Ranney, MD; Brown University

More Information

Publications:

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.

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

• Responsible Party: Megan L. Ranney Md MPH, Director, Brown-Lifespan Center for Digital Health, Rhode Island Hospital
• ClinicalTrials.gov Identifier: NCT04804189
• Other Study ID Numbers: R01CE003267 ( U.S. NIH Grant/Contract )
• First Posted: March 18, 2021
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

We will provide an open dataset containing anonymized IPD that results in a publication, along with open code from our analyses, and open access to research articles. The PIs will document collected data using the Data Documentation Initiative (DDI), which is recommended by the national data archive: the Inter-university Consortium for Political and Social Research (ICPSR). Audio interviews of participants consenting to be recorded will be transcribed and de-identified; audio recordings will not be available for analysis due to concerns about re-identifiability. Transcripts will only be available with participant consent, and de-identified transcripts would be made available to other researchers via a Data Use Agreement (DUA) facilitated by ICPSR.

We will deposit the aggregate data sets, survey and semi-structured interview instruments, analysis code, NVivo codes and associated codebook and relevant README documentation files in the ICPSR data archive.

• Supporting Materials: 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.
• URL: https://www.icpsr.umich.edu/web/pages/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Megan L. Ranney Md MPH, Rhode Island Hospital:

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

Additional relevant MeSH terms:

Wounds and Injuries