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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61MH125757-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Maniilaq Association | UNKNOWN |
| National Institute of Mental Health (NIMH) | NIH |
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Our parallel group clinical trial of the Family Safety Net (FSN) intervention addresses two main questions:
All participants will complete a baseline survey with firearm storage questions as well as 3 questions about mental health concerns in their family (e.g. 'Are you worried that someone in your home is at risk of suicide?').
If participants answer "yes" to any of the following family-focused mental health questions, they will be randomly assigned to one of the two FSN intervention groups (1 and 2 below): 1. In the past two months, has anyone in your household been going through a rough time? 2. In the past two months, has someone in your home seemed down, sad, or depressed? 3. Are you worried that someone in your home is at risk of suicide?
If they do not endorse any of the three family-focused mental health questions, they will be randomly assigned to one of two general firearm safety conditions (3 and 4 below).
Both FSN groups (1 and 2):
Can take home trigger locks, cable locks, ammo boxes, medication boxes and mental health resources
Receive 4 weeks of tailored text message reminders and encouragement.
Complete 1-month follow-up survey consisting of items related to firearm storage, and facilitating factors hypothesized to contribute to this behavior.
Participants in both FSN conditions will be invited to participate in a semi-structured interview at follow-up focused on satisfaction and perceptions of the program.
3 General gun safety intervention group will participate in a 10-minute scripted conversation about safe gun storage practice, and:
Can take home trigger locks, cable locks, and ammo boxes.
Receive 4 weeks of tailored text message reminders and encouragement.
Complete 1-month follow-up survey consisting of items related to firearm storage, and facilitating factors hypothesized to contribute to this behavior.
4. General gun safety comparison group:
Can take home trigger locks, cable locks, and ammo boxes.
Complete 1-month follow-up survey.
The primary goal of this parallel-group clinical trial is to test the Family Safety Net (FSN) intervention in a primarily Alaska Native population in NW Alaska. The main question[s] it aims to answer are:
Is the Family Safety Net (FSN) intervention acceptable in two formats, motivational interviewing counseling session, and scripted psychoeducational session, with a primarily Alaska Native population in Northwest Alaska?
Secondarily, our small trial will describe signals of efficacy in improving home safe storage of firearms (unloaded, locked with ammunition separate from firearms) and medication.
Participants will learn about the study from radio announcements or from receiving a respondent-driven sampling (RDS) coupon from another community member. We will aim to recruit an adult from at least 25% of the households in the community.
Participants will be asked verbally if they qualify for the study, which will additionally be confirmed in the first few questions on the baseline survey, before they are consented. Participants qualify for the study if they:
If the participant qualifies and agrees to participate, they will be brought to a private room by the research staff. Research staff will walk through the screening criteria in the survey with the participant and go through the consent form on the iPad or on paper and answer the participant's questions. If they agree to participate, they will mark their consent, for both their participation and separately to have their session recorded, and additionally be offered a paper copy of the consent form to take home.
Once consented, participants will be asked to complete a 10-15-minute baseline survey on the iPad. The survey will be done independently or with the help of the researcher if troubled by reading comprehension or navigating the iPad technology.
Participants will be screened into either the lethal-means reduction-focused FSN program or the general firearm safety program based on their survey responses. If a respondent answers "yes" to one of the following questions, they are in the lethal-means reduction FSN arm of the program:
They are then randomly assigned into one of two groups using a grouped randomization table:
The lethal means reduction MI FSN group (n=10) will:
Participate in a short 20-minute motivational interviewing (MI) session that includes:
Pick out safe storage devices to take home (e.g. trigger locks, cable locks, ammo boxes, medicine boxes, mental health crisis resources, local safety resources, etc.)
Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
Receive 4 weeks of text messages tailored by their survey responses (1x to 4x weekly depending on baseline survey responses). They may opt-out at any time.
The lethal means reduction bulleted script FSN group (n=10) will:
The general firearm safety intervention group (n=10) will:
Researchers will compare people from the same population as the general gun safety group to see if household firearm storage practices change because of the scripted conversation around gun safety.
The general firearm safety comparison group (n=10) will:
All participants will be compensated for their time taking the baseline survey, regardless of group assignment.
One month after the initial session, a link will be sent to participants via text/email to complete a 10-15-minute (depending on skip logic) follow-up survey. The follow-up survey consists of items related to firearm storage and facilitating factors hypothesized to contribute to this behavior. The survey will include items focused on mechanisms of change, including self-efficacy, and on the current household gun storage (# and type of firearm; locked/unlocked, loaded/unloaded and location of ammo for each) and actions taken to support mental wellness for others in their home. Additionally, participants will also answer questions about their satisfaction with the FSN (acceptability, cultural responsiveness). For both comparison and intervention groups, the follow-up will capture a "snapshot" of current household firearm storage practices that day.
Participants will additionally be invited at the follow-up to take part in a 20-minute phone interview (semi-structured) also one month after their initial session. The follow-up semi-structured interview consists of questions about satisfaction with the program, what participants liked and didn't like, follow-up questions on the mental health concerns they have in their home, and follow-up on what they did with the home safety equipment they brought home and why as well as how the supplies worked for them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSN Lethal Means Scripted Intervention | Experimental | Participants were randomized to one of two lethal-means reduction-focused FSN programs if they answer "yes" to any of the screening questions. The scripted FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. Using a handout depicting a typical home, participants review where firearms, ammunition, and medications are stored, reinforcing that "10 minutes can save a life" and encouraging the display of mental health resources. Participants receive safe firearm storage materials and #988 crisis line magnets and stickers. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
|
| General Firearm Safety Comparison | Active Comparator | Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions:
|
|
| Experimental: FSN Lethal Means MI Counseling | Experimental | Participants will be screened into one of two lethal-means reduction-focused FSN programs if they answer "yes" to one or more of the screening questions. The MI FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. The MI session asked broad open-ended questions about what that person might do to increase environmental safety in their home. At the end of the session, participants were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI FSN - Lethal Means Reduction | Behavioral | Motivational Interviewing lethal means reduction, firearm storage supplies, Tailored text messages
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention | Feasibility was measured by examining the number of people who met eligibility criteria and chose to participate in the study. This basic process measure allowed us to assess the scope and scalability of the FSN intervention. | Baseline |
| Participant Agreement With the Statement: "I am Glad I Participated in the Family Safety Net" | Participants were asked how much they agree with the statement "I am glad I participated in the Family Safety Net" using a 10-point Likert scale (1-10 agreement scale). Items with an average 5.5 or more were considered acceptable. | Assessed at 6 week follow up |
| Participant Agreement With the Statement: "I Would Recommend the Family Safety Net" | Participants were asked how much they agree with the statement "I would recommend the Family Safety Net" using a 10-point Likert scale (1-10 agreement scale). Items with an average 5.5 or more were considered acceptable. | Assessed at 6 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Household Firearm Storage | We developed a firearm inventory to assess safety practices for up to five firearms in the home. For each reported firearm, participants indicated whether: (1) the firearm was locked with a cable or trigger lock or stored in a locked gun safe or cabinet; (2) the firearm was unloaded; (3) ammunition was stored separately from the firearm; and (4) the ammunition was locked in an ammunition box. Each safe storage practice endorsed was assigned one point, yielding a score of 0-4 per firearm. Scores were then averaged across all reported firearms to create a composite safe storage score. If a participant reported that a firearm named on the baseline was no longer in the home at follow-up, they were asked if they had moved the firearm out of the house for safety reasons. If they removed a firearm, they were not asked the safe storage questions for that firearm, and it was not calculated in the total composite score. |
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Inclusion Criteria:
Adults (over 18) who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Wexler, PhD, MSW | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maniilaq Association | Kotzebue | Alaska | 99752 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29879094 | Background | Stone DM, Simon TR, Fowler KA, Kegler SR, Yuan K, Holland KM, Ivey-Stephenson AZ, Crosby AE. Vital Signs: Trends in State Suicide Rates - United States, 1999-2016 and Circumstances Contributing to Suicide - 27 States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jun 8;67(22):617-624. doi: 10.15585/mmwr.mm6722a1. | |
| Background | Blake I, Holck P, Provost EM. Alaska native mortality update: 2009-2013. Alsk Native Epidemiol. Published online 2016. | ||
| Background | Parker K. Alaska Trauma Registry. Trauma Admissions Involving Firearms; 2016. | ||
| 24592495 |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention, Web-based Injury Statistics Query and Reporting System (WISQARS). Fatal Injury Reports, Calculations were based on five years of most recently available data: 2013 to 2017. | View source |
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Participants who endorsed any of the three screening questions were randomized to one of two Family Safety Network (FSN) interventions; those who did not were randomized to one of two general firearm safety interventions.
The study occurred between March and May 2023 in a small community in Northwest Alaska. Participants were adults who had lived in the region for at least five years, in a home with one or more firearms, who had a cell phone that received text messages. Participants were invited to come to a community building to meet with researchers through flyers, word-of-mouth invitations, and local radio announcements.
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| ID | Title | Description |
|---|---|---|
| FG000 | FSN Lethal Means Scripted Intervention | The scripted FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. Using a handout depicting a typical home, participants review where firearms, ammunition, and medications are stored, reinforcing that "10 minutes can save a life" and encouraging the display of mental health resources. Participants receive safe firearm storage materials and #988 crisis line magnets and stickers. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2023 |
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Using a parallel group design trial, our design considers the acceptability, feasibility and signals of impact of two different interventions: (1) the Family Safety Net for those whose household may benefit from lethal means reduction counseling due to having someone in their home who is struggling; and (2) a General Firearm Safety intervention for households with firearms who did not endorse an item on the family-focused mental health screening.
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|
| General Firearm Safety Intervention | Active Comparator | Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions:
|
|
|
| Scripted FSN - Lethal Means Reduction | Behavioral | Scripted lethal means reduction, firearm storage supplies, tailored text messages
|
|
| General Firearm Safety Intervention - General Firearm Safety | Behavioral | General information on gun safety, firearm storage supplies, tailored text messages
|
|
| General Firearm Comparison - General Firearm Safety | Behavioral | firearm storage supplies * Be offered to take home safe gun storage materials, including trigger locks, cable locks, and ammo boxes |
|
| Assessed at baseline and 6-week follow up; 6 week follow up reported |
| Background |
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| 19413785 | Result | Apodaca TR, Longabaugh R. Mechanisms of change in motivational interviewing: a review and preliminary evaluation of the evidence. Addiction. 2009 May;104(5):705-15. doi: 10.1111/j.1360-0443.2009.02527.x. |
| Result | Kelley K. Confidence Intervals for Standardized Effect Sizes: Theory, Application, and Implementation. J Stat Softw. 2007;20(8). doi:10.18637/jss.v020.i08 |
| FG001 | General Firearm Safety Comparison | Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes. |
| FG002 | FSN Lethal Means MI Counseling | The MI FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. The MI session asked broad open-ended questions about what that person might do to increase environmental safety in their home. At the end of the session, participants were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
| FG003 | General Firearm Safety Intervention | Participants in the general safety intervention were offered safe-storage resources and received a scripted general safety session encouraging locking and unloading firearms at home. |
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis includes only information from participants who completed both baseline and follow-up surveys
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FSN Lethal Means MI Counseling | The MI FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. The MI session asked broad open-ended questions about what that person might do to increase environmental safety in their home. At the end of the session, participants were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
| BG001 | FSN Lethal Means Scripted Intervention | The scripted FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. Using a handout depicting a typical home, participants review where firearms, ammunition, and medications are stored, reinforcing that "10 minutes can save a life" and encouraging the display of mental health resources. Participants receive safe firearm storage materials and #988 crisis line magnets and stickers. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
| BG002 | General Firearm Safety Intervention | Participants in the general safety intervention were offered safe-storage resources and received a scripted general safety session encouraging locking and unloading firearms at home. |
| BG003 | General Firearm Safety Comparison | Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Analysis includes only information from participants who completed both baseline and follow-up surveys | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Analysis includes only information from participants who completed both baseline and follow-up surveys | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Northwest Alaska - Health Region served by Maniilaq Association | Analysis includes only information from participants who completed both baseline and follow-up surveys | Number | Participants |
| |||||||||
| Household Firearm Storage | We developed a firearm inventory to assess safety practices for up to five firearms in the home. For each reported firearm, participants indicated whether: (1) the firearm was locked with a cable or trigger lock or stored in a locked gun safe or cabinet; (2) the firearm was unloaded; (3) ammunition was stored separately from the firearm; and (4) the ammunition was locked in an ammunition box. Each safe storage practice endorsed was assigned one point, yielding a score of 0-4 per firearm. Scores were then averaged across all reported firearms to create a composite safe storage score. | Analysis includes only information from participants who reported having one or more firearms in their home. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Intervention | Feasibility was measured by examining the number of people who met eligibility criteria and chose to participate in the study. This basic process measure allowed us to assess the scope and scalability of the FSN intervention. | For this outcome measure, the overall number of participants analyzed is higher than our n because it includes those who were screened but subsequently declined to participate in the study. Only data for the FSN Lethal Means Intervention and General Firearm Safety Comparisons Arms are reported for this outcome measure. This measure represents participants prior to being randomized to the other two Arms. | Posted | Count of Participants | Participants | Baseline |
|
|
| |||||||||||||||||||||||||||||
| Primary | Participant Agreement With the Statement: "I am Glad I Participated in the Family Safety Net" | Participants were asked how much they agree with the statement "I am glad I participated in the Family Safety Net" using a 10-point Likert scale (1-10 agreement scale). Items with an average 5.5 or more were considered acceptable. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 6 week follow up |
| |||||||||||||||||||||||||||||||
| Primary | Participant Agreement With the Statement: "I Would Recommend the Family Safety Net" | Participants were asked how much they agree with the statement "I would recommend the Family Safety Net" using a 10-point Likert scale (1-10 agreement scale). Items with an average 5.5 or more were considered acceptable. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 6 week follow up |
| |||||||||||||||||||||||||||||||
| Secondary | Household Firearm Storage | We developed a firearm inventory to assess safety practices for up to five firearms in the home. For each reported firearm, participants indicated whether: (1) the firearm was locked with a cable or trigger lock or stored in a locked gun safe or cabinet; (2) the firearm was unloaded; (3) ammunition was stored separately from the firearm; and (4) the ammunition was locked in an ammunition box. Each safe storage practice endorsed was assigned one point, yielding a score of 0-4 per firearm. Scores were then averaged across all reported firearms to create a composite safe storage score. If a participant reported that a firearm named on the baseline was no longer in the home at follow-up, they were asked if they had moved the firearm out of the house for safety reasons. If they removed a firearm, they were not asked the safe storage questions for that firearm, and it was not calculated in the total composite score. | Analysis includes only information from participants who reported having one or more firearms in their home. the number of participants analyzed for this outcome measure is lower than what was reported at baseline due to the fact that some participants reported they did not have the firearm(s) they reported to have at baseline at the 6 week follow up. Only participants who reported having a firearm at baseline AND at the 6-week follow up were included in this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and 6-week follow up; 6 week follow up reported |
|
From enrollment until the end of follow-up, up to 8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FSN Lethal Means MI Counseling | The MI FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. The MI session asked broad open-ended questions about what that person might do to increase environmental safety in their home. At the end of the session, participants were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | FSN Lethal Means Scripted Intervention | The scripted FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. Using a handout depicting a typical home, participants review where firearms, ammunition, and medications are stored, reinforcing that "10 minutes can save a life" and encouraging the display of mental health resources. Participants receive safe firearm storage materials and #988 crisis line magnets and stickers. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | General Firearm Safety Intervention | Participants in the general safety intervention were offered safe-storage resources and received a scripted general safety session encouraging locking and unloading firearms at home. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | General Firearm Safety Comparison | Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes. | 0 | 21 | 0 | 21 | 0 | 21 |
Not provided
Not provided
Participants were a self-selected sample interested in joining a study that included firearm safety supplies as incentives. The convenient sample was recruited in one small community, which limits the generalizability of these findings. Along with this selection bias, social desirability could affect follow up responses.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Wexler, Research Professor, Institute for Social Research | University of Michigan | 7347647806 | Lwexler@umich.edu |
| Jan 14, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2023 | Jan 14, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D000081084 | Accidental Injuries |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014947 | Wounds and Injuries |
Not provided
Not provided
|
|
|
|
|
| OG002 | General Firearm Safety Intervention | Participants in the general safety intervention were offered safe-storage resources and received a scripted general safety session encouraging locking and unloading firearms at home. |
| OG003 | General Firearm Safety Comparison | Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes. |
|
|
| OG002 | General Firearm Safety Intervention | Participants in the general safety intervention were offered safe-storage resources and received a scripted general safety session encouraging locking and unloading firearms at home. |
| OG003 | General Firearm Safety Comparison | Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes. |
|
|
| OG001 | FSN Lethal Means Scripted Intervention | The scripted FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home. Using a handout depicting a typical home, participants review where firearms, ammunition, and medications are stored, reinforcing that "10 minutes can save a life" and encouraging the display of mental health resources. Participants receive safe firearm storage materials and #988 crisis line magnets and stickers. They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices). |
| OG002 | General Firearm Safety Comparison | Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes. |
| OG003 | General Firearm Safety Intervention | Participants in the general safety intervention were offered safe-storage resources and received a scripted general safety session encouraging locking and unloading firearms at home. |
|
|