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

NCT06886776 | Enrolling By Invitation DMC

• 2 other identifiers: FP00003311R01NR021291
• Study Type: interventional
• Target: 1,086
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicide

Keywords

Implementation science; Firearms; Suicide; Pediatrics; Federally qualified health centers

Outcome Measures

Primary Outcomes (2)

• Reach

  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.

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

• Locks distributed

  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.

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

Secondary Outcomes (2)

• Firearm storage behavior

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

• Acceptability

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

Study Arms (3)

Control/usual care

NO INTERVENTION

During the control 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 active implementation phase. All sites will be in the control data collection phase for at least three months before having the interventions activated.

Active implementation phase (training and facilitation received, S.A.F.E. Firearm delivered)

EXPERIMENTAL

Once a group of clinics crosses over from the control 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 during their child's well-visit and offering them a free cable firearm lock. This active implementation phase will last for 12 months.

Behavioral: Implementation package (training and facilitation)

Sustainment (training and facilitation removed)

NO INTERVENTION

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.

Interventions

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.

Active implementation phase (training and facilitation received, S.A.F.E. Firearm delivered)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst will be blinded to randomization assignment
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Model Details: Stepped wedge randomized controlled trial

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: July 14, 2026
• Primary Completion (Estimated): January 13, 2029
• Study Completion (Estimated): January 13, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

US (1)