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Enrolling by Invitation

NCT Number: NCT06886776

Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)

This randomized controlled trial will take place in up to 15 community health centers across the state of Illinois. Researchers will be studying S.A.F.E. Firearm, a program that aims to increase secure storage of firearms in homes with children. Specifically, S.A.F.E. Firearm includes a brief conversation between pediatric clinicians and parents/guardians about secure firearm storage and an offer of a free cable firearm lock within the well-child visit. Researchers will also study a package of strategies to help pediatric clinics incorporate this new practice. The strategies include training for clinic personnel and facilitation, or tailored problem-solving support.

The questions the study aims to answer are:

* How effective is the package of strategies at helping pediatric clinics implement this new practice? * How effective is the S.A.F.E. Firearm program at changing parents', caregivers' and guardians' (hereafter, "parents") firearm storage behavior?

Some parents will be invited to complete a brief survey after their visit about their experiences receiving S.A.F.E. Firearm. Some community health center personnel will also be invited to complete an interview about their experiences with S.A.F.E. Firearm and the package of strategies.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

While some large health systems have successfully implemented secure firearm storage programs such as S.A.F.E. Firearm into routine practice, there is limited research on the implementation of secure firearm storage programs in community settings, such as community health centers, which serve large populations of Americans. These settings often face challenges such as financial pressures and high staff turnover, which were made worse by the COVID-19 pandemic. Therefore, before deploying a secure firearm storage program in this new setting, adaptation is needed. As part of Aim 1 of the grant funding this project, the research team is working with local community-based organizations, firearm safety experts, community health center personnel, and parents, guardians, and caregivers (hereafter, "parents") to understand the changes that need to be made to the S.A.F.E. Firearm program and the package of implementation strategies that have been successfully used in previous studies to help pediatric clinics implement this new practice (training, facilitation). The research team will incorporate needed changes before the present trial will begin.

In the present study, the research team will conduct a hybrid type III effectiveness-implementation trial to test the effect of the adapted S.A.F.E. Firearm program and associated strategies. The trial will be conducted across pediatric well-visits in community health centers across the state of Illinois using a stepped wedge design. Clinics will be randomized into clusters of clinics and the implementation approach (staff training, facilitation) will be activated upon the start of each step.

Aims for the study include:

Aim 2. We will conduct a pragmatic hybrid type III stepped wedge effectiveness-implementation randomized controlled trial with community health centers across Illinois to test the effectiveness of our adapted implementation approach on parent-reported receipt of S.A.F.E. Firearm (i.e., reach; co-primary implementation outcome) and distribution of cable locks by the clinics (co-primary implementation outcome). We will also assess secondary implementation outcomes (stage of implementation, cost, acceptability) and effectiveness outcomes (parent firearm storage behavior).

Aim 3. We will use mixed methods to identify mechanisms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parent participants

  • Be a parent, caregiver, or legal guardian of a child ages 0-17 who has a well-visit at a participating health care clinic in the state of Illinois
  • Attend the child's well-visit

Health care personnel

  • Be employed at a participating health care clinic in the state of Illinois
  • Aged 18+ years

Exclusion criteria

  • None

Treatment and study plan

Implementation package (training and facilitation)

Behavioral

Training includes an initial presentation on S.A.F.E. Firearm, S.A.F.E. Firearm informational guides and other resources to support delivery, and recommendations for additional, optional self-guided learning resources.

Facilitation will last twelve months at each site. It may involve 1) a pre-implementation readiness assessment for each clinic to identify potential implementation barriers and develop relationships with constituents; 2) kick-off meetings, at which clinic staff will confirm how and where S.A.F.E. Firearm will be implemented within the clinic; 3) goal-setting; 4) trouble-shooting to address barriers identified during the pre-implementation readiness assessment and emergent challenges; and 5) designing a sustainment plan to maintain S.A.F.E. Firearm for future years.

Primary outcomes

  1. Reach

    Time frame: 2.5 years (duration of the study - control through sustainment)

    The proportion of eligible parents who report receiving both S.A.F.E. Firearm intervention components (counseling and lock). The two questions comprising reach ask the parent to report whether the following occurred during their child's recent visit: a member of the health center staff (1) spoke to them about firearm storage and (2) offered them a free firearm lock(s), even if they didn't take one. Response options to each of these questions include: yes, no, don't remember, and prefer not to answer.

  2. Locks distributed

    Time frame: 2.5 years (duration of the study - control through sustainment)

    The distribution of locks taken during the control phase, active implementation phase, and sustainment phase. Locks for distribution during the active implementation and sustainment phases will be ordered through the study team only. The study team will reach out to each clinic approximately 1 week prior to start of active implementation to ask how many locks were distributed during the control period. The study team will then track how many locks are ordered from each clinic and obtain an estimate from clinics 1 week prior to the end of active implementation of how many locks were distributed during the active implementation phase, and do the same for sustainment.

Secondary outcomes

  1. Firearm storage behavior

    Time frame: 2.5 years (duration of the study - control through sustainment)

    Firearm storage behavior will be ascertained via parental self-report. These parents will be asked whether, since their child's visit, they've taken any actions to ensure their child cannot access firearm(s) without permission. Parents will be able to select one or multiple response options: unloaded, locked, locked ammunition separate from firearm(s), talked to someone else about ensuring the child cannot access firearm(s), other, no action, or prefer not to answer. Parents will also be provided with definitions and graphics that depict locked, unloaded, and locking ammunition separately.

  2. Acceptability

    Time frame: 2.5 years (duration of the study - control through sustainment)

    Acceptability will be measured using the brief questions used in our prior "ASPIRE" trial (R01MH123491), which ask whether the parent found it acceptable to have the secure firearm storage conversation; and whether they found it acceptable to have free firearm lock(s) offered to them during the visit. Response options for both: yes, no, prefer not to answer. Participants who report not receiving S.A.F.E. Firearm will be asked if they would have found these components acceptable.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • AllianceChicago
  • Illinois Primary Health Care Association
  • National Institute of Nursing Research (NINR)
  • University of Pennsylvania

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 20, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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