Firearm InjuryNCT06719713
Store Safely: Rural Firearm Injury Prevention for Families
A study testing Store Safely in people with Firearm Injury, run by University of Michigan at 2 sites in United States.
Trial summary
The researchers are testing a firearm safety prevention strategy tailored for families with children who reside in a rural area. Researchers hypothesize that the intervention will lead to improvements in household firearm storage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Firearm Injury
- What is being tested?
- Store Safely
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2025to May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Age 18 or older
- English-speaking
- Have a child under 18 living at home
- Currently keep at least one firearm on their property
- Reside in Michigan's Upper Peninsula (U.P.)
- Access to a computer/mobile device and wifi
- Have sufficient information about household storage to complete surveys
Who cannot join
- Unable to be consented in English
- Under the age of 18
- Lack of firearm on their property
- No child in the home
- Residence outside the U.P.
- No access to technology
- Previously enrolled in 2020 pilot project
- Previously access the Store Safely website
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Christina Magness, 734-252-6315, cmagness@med.umich.edu
Cynthia Ewell Foster, Ph.D.
- Recruiting
Marquette County Health Department
Negaunee, Michigan, 49866
Sarah Derwin, 906-475-9977, sderwin@mqtco.gov
Cynthia Ewell Foster
About this study
The researchers are testing a firearm safety prevention strategy tailored for families with children who reside in a rural area. Researchers hypothesize that the intervention will lead to improvements in household firearm storage.
- Conditions
- Firearm Injury
- Being tested
- Store Safely
- Keywords
- rural, firearm safe storage, injury prevention, suicide prevention, community education
- Medical subject headings
- Suicide Prevention, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Store SafelyBehavioural
The Store Safely intervention occurs online and is self-administered. Once directed to the Store Safely website, participants are welcomed and instructed to complete each step of the online program. Upon clicking "Start," participants are taken to Step 1 of the intervention and instructed to review a brief video. Step 2 involves a review of a data infographics. Participants are then directed to the Decision Aid in Step 3. In Step 4, participants are instructed to complete the Family Firearm Storage Action Plan. In Step 5, participants will review another brief video. There will also be an optional step, consisting of a resource page that details local options for obtaining safe storage devices. At the end of each step, participants mark a checkbox to indicate they have completed the intervention activity which facilitates website analytics of participant engagement. Lastly, participants are thanked and provided with details about the final steps of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Store Safely | Experimental | The Store Safely arm (consisting of a community sample) will receive the Store Safely intervention, usual community-based care, and 988 suicide and crisis lifeline number and a publicly available safe storage information resource numbers. Receives: Behavioral: Store Safely |
| Waitlist control | No intervention | The waitlist control group (consisting of a community sample) will not receive the intervention during the clinical trial but will be offered 988 suicide and crisis lifeline number and a publicly available safe storage information resource numbers. Following the clinical trial they will have access to the Store Safely intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of firearms stored locked
Measured using a self-report item from the Family Firearm Storage Behaviors Survey (Ewell Foster et al., 2024) administered at 3 months. May range from 1-40 based on pilot data
Measured: Approximately 3 months
Parent Engagement in Harm Reduction Firearm Storage Behaviors Score
Measured using the Family Firearm Storage Behaviors Survey (Ewell Foster et al., 2024) administered at 3 months. The survey is 14 items, endorsed as Y/N. Score range is 0-14.
Measured: Approximately 3 months
Secondary outcomes (3)
Parent Self-Efficacy for Firearm Safety Questionnaire
Measured: Baseline, Immediate/2-Week
Number of firearms unloaded
Measured using a self-report item from the Family Firearm Storage Behaviors Survey (Ewell Foster et al., 2024) administered at 3 months.
Measured: Approximately 3 months
Number of firearms unlocked and loaded
Measured using a self-report item from the Family Firearm Storage Behaviors Survey (Ewell Foster et al., 2024) administered at 3 months.
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start11 Aug 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist control and intervention
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Marquette County Health Department
- Responsible party
- Principal investigator, Cynthia Ewell Foster, University of Michigan
- Investigators
- Cynthia Ewell Foster, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719713
- Sponsor's protocol ID
- HUM00250518
- Other IDs
- 1 R01CE003629-01-00, 1R01CE003629-01
- Status last verified
- May 2026
- First submitted
- 3 Dec 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is complete and data has been cleaned and de-identified, the archived data will be transmitted to and securely stored at the University of Michigan Institute for Firearm Injury Prevention Data Repository, for use by other researchers including those outside of the study.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Store Safely: Rural Firearm Injury Prevention for Families
- ClinicalTrials.gov ID
- NCT06719713
- Acronym / sponsor ID
- HUM00250518
- Conditions
- Firearm Injury
- Keywords
- rural, firearm safe storage, injury prevention, suicide prevention, community education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Marquette County Health Department
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Dec 2024 (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.
The researchers are testing a firearm safety prevention strategy tailored for families with children who reside in a rural area. Researchers hypothesize that the intervention will lead to improvements in household firearm storage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control and intervention
| Arm | Type | Receives |
|---|---|---|
| Store Safely | Experimental | Behavioral: Store SafelyThe Store Safely arm (consisting of a community sample) will receive the Store Safely intervention, usual community-based care, and 988 suicide and crisis lifeline number and a publicly available safe storage information resource numbers. |
| Waitlist control | No intervention | –The waitlist control group (consisting of a community sample) will not receive the intervention during the clinical trial but will be offered 988 suicide and crisis lifeline number and a publicly available safe storage information resource numbers. Following the clinical trial they will have access to the Store Safely intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Age 18 or older
- English-speaking
- Have a child under 18 living at home
- Currently keep at least one firearm on their property
Key exclusion criteria (8 listed)
- Unable to be consented in English
- Under the age of 18
- Lack of firearm on their property
- No child in the home
- Residence outside the U.P.
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 |
|---|---|---|
| Store SafelyThe Store Safely intervention occurs online and is self-administered. Once directed to the Store Safely website, participants are welcomed and instructed to complete each step of the online program. Upon clicking "Start," participants are taken to Step 1 of the intervention and instructed to review a brief video. Step 2 involves a review of a data infographics. Participants are then directed to the Decision Aid in Step 3. In Step 4, participants are instructed to complete the Family Firearm Storage Action Plan. In Step 5, participants will review another brief video. There will also be an optional step, consisting of a resource page that details local options for obtaining safe storage devices. At the end of each step, participants mark a checkbox to indicate they have completed the intervention activity which facilitates website analytics of participant engagement. Lastly, participants are thanked and provided with details about the final steps of the trial. | Behavioural | Store Safely |
Primary outcome
Number of firearms stored locked
Time frame: Approximately 3 months
Measured using a self-report item from the Family Firearm Storage Behaviors Survey (Ewell Foster et al., 2024) administered at 3 months. May range from 1-40 based on pilot data
Parent Engagement in Harm Reduction Firearm Storage Behaviors Score
Time frame: Approximately 3 months
Measured using the Family Firearm Storage Behaviors Survey (Ewell Foster et al., 2024) administered at 3 months. The survey is 14 items, endorsed as Y/N. Score range is 0-14.
3 secondary outcomes
Parent Self-Efficacy for Firearm Safety Questionnaire
Time frame: Baseline, Immediate/2-Week
Number of firearms unloaded
Time frame: Approximately 3 months
Number of firearms unlocked and loaded
Time frame: Approximately 3 months
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 14 May 2026.
- Individual participant dataSharing planned: Yes. After the study is complete and data has been cleaned and de-identified, the archived data will be transmitted to and securely stored at the University of Michigan Institute for Firearm Injury Prevention Data Repository, for use by other researchers including those outside of the study.
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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.
Cynthia Ewell Foster, Ph.D. principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Store Safely in people with Firearm Injury, run by University of Michigan at 2 sites 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Christina Magness (734-252-6315, cmagness@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of firearms stored locked (time frame: Approximately 3 months). 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 14 May 2026.