- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06719713
Store Safely: Rural Firearm Injury Prevention for Families
May 13, 2026 updated by: Cynthia Ewell Foster, University of Michigan
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 Overview
Study Type
Interventional
Enrollment (Estimated)
600
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
- Name: Christina Magness
- Phone Number: 734-252-6315
- Email: cmagness@med.umich.edu
Study Contact Backup
- Name: Lauren Majlinger, BA
- Phone Number: 7349312162
- Email: lmajling@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Not yet recruiting
- University of Michigan
-
Contact:
- Christina Magness
- Phone Number: 734-252-6315
- Email: cmagness@med.umich.edu
-
Principal Investigator:
- Cynthia Ewell Foster, Ph.D.
-
Negaunee, Michigan, United States, 49866
- Recruiting
- Marquette County Health Department
-
Contact:
- Sarah Derwin
- Phone Number: 906-475-9977
- Email: sderwin@mqtco.gov
-
Principal Investigator:
- Cynthia Ewell Foster
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Store Safely
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.
|
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.
|
|
No Intervention: Waitlist control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Approximately 3 months
|
|
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.
|
Approximately 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Self-Efficacy for Firearm Safety Questionnaire
Time Frame: Baseline, Immediate/2-Week
|
Baseline, Immediate/2-Week
|
|
|
Number of firearms unloaded
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.
|
Approximately 3 months
|
|
Number of firearms unlocked and loaded
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.
|
Approximately 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Ewell Foster, Ph.D., University of Michigan
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 (Actual)
August 11, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
December 3, 2024
First Submitted That Met QC Criteria
December 3, 2024
First Posted (Actual)
December 6, 2024
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00250518
- 1 R01CE003629-01-00 (Other Grant/Funding Number: Centers for Disease Control and Prevention)
- 1R01CE003629-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
After the study is completed and available according to Firearm Injury Prevention Data Repository policy.
IPD Sharing Access Criteria
Researchers can request data from the study contacts listed in the study.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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