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

NCT06886776 | Not Yet Recruiting DMC

• 2 other identifiers: FP00003311R01NR021291
• Study Type: interventional
• Target: 666
• 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 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.

Conditions

Suicide

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Parent-reported reach of S.A.F.E. Firearm

  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)

Study Arms (3)

Baseline/usual care

NO INTERVENTION

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.

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

EXPERIMENTAL

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)

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 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.

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 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

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

Study Sites (1)

Illinois Primary Health Care Association

Springfield, Illinois, 62704, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Rinad S Beidas, PhD

CONTACT

312-503-0546; Rinad.beidas@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst and biostatistician 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 (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)