NCT06719713

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Aug 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Aug 2025May 2027

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 23, 2026

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

December 3, 2024

Last Update Submit

January 21, 2026

Conditions

Keywords

ruralfirearm safe storageinjury preventionsuicide preventioncommunity education

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Approximately 3 months

Secondary Outcomes (3)

  • Parent Self-Efficacy for Firearm Safety Questionnaire

    Baseline, Immediate/2-Week

  • Number of firearms unloaded

    Approximately 3 months

  • Number of firearms unlocked and loaded

    Approximately 3 months

Study Arms (2)

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.

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.

Interventions

Store SafelyBEHAVIORAL

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.

Store Safely

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • English-speaking
  • Have a child under 18 living at home
  • Own at least one firearm
  • Reside in Michigan's Upper Peninsula (UP)
  • Access to a computer/mobile device and wifi
  • Have sufficient information about household storage to complete surveys

You may not qualify if:

  • Unable to be consented in English
  • Lack of firearm in the home
  • No child in the home
  • Residence outside the UP
  • No access to technology
  • Previously enrolled in 2020 pilot project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Marquette County Health Department

Negaunee, Michigan, 49866, United States

RECRUITING

MeSH Terms

Conditions

Suicide PreventionHealth Education

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Cynthia Ewell Foster, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Magness

CONTACT

Lauren Majlinger, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Waitlist control and intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Psychiatry

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

August 11, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 23, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After the study is completed and available according to Firearm Injury Prevention Data Repository policy.
Access Criteria
Researchers can request data from the study contacts listed in the study.
More information

Locations