SuicideNCT06886776
Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)
A study testing Implementation package (training and facilitation) in people with Suicide, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide
- What is being tested?
- Implementation package (training and facilitation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2026to 13 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Suicide
- Being tested
- Implementation package (training and facilitation)
- Keywords
- Implementation science, Firearms, Suicide, Pediatrics, Federally qualified health centers
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation package (training and facilitation)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2.5 years (duration of the study - control through sustainment)
Secondary outcomes (2)
Firearm storage behavior
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.
Measured: 2.5 years (duration of the study - control through sustainment)
Acceptability
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.
Measured: 2.5 years (duration of the study - control through sustainment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start14 Jul 2026
- Primary completion13 Jan 2029 (estimated)
- Study completion13 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,086 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- AllianceChicago, Illinois Primary Health Care Association, University of Pennsylvania, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rinad Beidas, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886776
- Sponsor's protocol ID
- FP00003311
- Other IDs
- R01NR021291
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)
- ClinicalTrials.gov ID
- NCT06886776
- Acronym / sponsor ID
- FP00003311
- Conditions
- Suicide
- Keywords
- Implementation science, Firearms, Suicide, Pediatrics, Federally qualified health centers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,086 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- AllianceChicago, Illinois Primary Health Care Association, University of Pennsylvania, National Institute of Nursing Research (NINR)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 13 Jan 2029 (estimated)
- Study completion
- 13 Jan 2029 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Stepped wedge randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Implementation package (training and facilitation)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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Behavioural | Active implementation phase (training and facilitation received, S.A.F.E. Firearm delivered) |
Primary outcome
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.
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.
2 secondary outcomes
Firearm storage behavior
Time frame: 2.5 years (duration of the study - control through sustainment)
Acceptability
Time frame: 2.5 years (duration of the study - control through sustainment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation package (training and facilitation) in people with Suicide, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 2.5 years (duration of the study - control through sustainment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.