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

May 28, 2026 updated by: Rinad Beidas, Northwestern University

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 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 adopt this new practice?
  • How effective is the S.A.F.E. Firearm program at changing parents' and guardians' firearm storage behavior?

Some parents and guardians 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

While some large health systems have successfully adopted 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 and guardians (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 adopt this new practice (training, facilitation, other strategies selected in tandem with partners in the adaptation process). 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, other strategies selected in tandem with partners in the adaptation process) 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 (training and facilitation emphasizing S.A.F.E. Firearm delivery) on parent-reported receipt of S.A.F.E. Firearm (i.e., reach; 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.

Study Type

Interventional

Enrollment (Estimated)

666

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62704
        • Illinois Primary Health Care Association
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Parent participants

  • Be a parent 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Baseline/usual care
During the baseline data collection phase, no individuals will be exposed to S.A.F.E. Firearm. No training or facilitation will be received. The length of the baseline data collection phase will differ between each "wedge" (i.e., group of clinics) depending on when the group is randomly assigned to cross over into the implementation phase. All sites will be in the baseline data collection phase for at least six months before having the interventions activated.
Experimental: Implementation phase (training and facilitation received, S.A.F.E. Firearm delivered)
Once a group of clinics crosses over from the baseline data collection phase, the implementation approaches (e.g., training, facilitation) and the S.A.F.E. Firearm program will be enacted. S.A.F.E. Firearm involves pediatric clinicians having a secure firearm storage discussion with a parent or guardian during their child's well-visit and offering them a free cable firearm lock. This implementation phase will last for 12 months.
Behavioral: Implementation package (training and facilitation)

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 the launch of the trial, at which clinic staff will identify how and where S.A.F.E. Firearm will be implemented within the clinic; 3) goal-setting within the first few months of the program; 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.
No Intervention: Sustainment (training and facilitation removed)

Following the conclusion of the 12 months in which the implementation approaches (training and facilitation) are used at a clinic, outcomes will be assessed for the duration of the study during a "sustainment" window.

No additional training or facilitation will be received during the sustainment period following the experimental period. However, clinics will still continue to deliver S.A.F.E. Firearm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported reach of S.A.F.E. Firearm
Time Frame: Reach will be collected via survey sent to parents after well-visits for the 3-year study period (baseline through sustainment phases)
The proportion of eligible pediatric well-visits for which parents report receiving the two components of S.A.F.E. Firearm (discussion of secure firearm storage, offer of a free cable firearm lock)
Reach will be collected via survey sent to parents after well-visits for the 3-year study period (baseline through sustainment phases)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP00003311
  • R01NR021291 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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