Family Safety Net - Aim 3: Randomized Control Trial (FSN)

Family Safety Net: Developing an Upstream Suicide Prevention Approach to Encourage Safe Firearm Storage in Rural and Remote

Our parallel group clinical trial of the Family Safety Net (FSN) intervention addresses two main questions:

• Is the Family Safety Net (FSN) intervention feasible and acceptable in two formats: motivational interviewing (FSN MI) counseling session and scripted psychoeducational session (FSN Scripted), with a primarily Alaska Native population in Northwest Alaska?
• Secondarily, are there signals of efficacy at improving home safety (firearms unloaded, locked with ammunition separate) and dangerous medication locked?

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).

  1. FSN MI group will participate in a 15-20-minute motivational interviewing (MI) session conducted by trained research staff focused on suicide lethal means reduction.
  2. FSN Scripted group will participate in a 10-minute scripted session focused on suicide lethal means reduction.

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.

Study Overview

• Status: Completed
• Conditions: Suicide; Accidental Injuries; Firearm Injury
• Intervention / Treatment: Behavioral: MI FSN - Lethal Means Reduction; Behavioral: Scripted FSN - Lethal Means Reduction; Behavioral: General Firearm Safety Intervention - General Firearm Safety; Behavioral: General Firearm Comparison - General Firearm Safety

Detailed Description

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:

  1. Are 18 or older
  2. Live in a home with at least one firearm
  3. Live in a home where young people (under 29) spend time
  4. Live in the region
  5. Are the only person from their household to participate in the study
  6. Have a cell phone that gets text messages
• 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:

  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?

They are then randomly assigned into one of two groups using a grouped randomization table:

1. The lethal means reduction MI FSN group (n=10) will:

   1. Participate in a short 20-minute motivational interviewing (MI) session that includes:

      1. introduction to the session and setting the agenda;
      2. discussing the person's goals and strengths related to keeping loved ones safe through safe firearm and medication storage (e.g. making one's home safer to protect the youth or other family living there) and supporting wellness (i.e. mental health promotion);
      3. offering normative feedback about safe firearm storage practices within the community;
      4. talk about the benefits of safer firearm and medication storage practices (e.g. enhancing youth safety or avoiding youth harm);
      5. action planning to increase self-efficacy to overcome barriers and move toward reducing access to firearms and medications by locking and unloading all household guns and medications; and
      6. summarizing key content of the session to re-enforce benefits, goals, and values and support self-efficacy to facilitate safe firearm and medication storage practices and wellness support at home.
   2. 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.)
   3. Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
   4. 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.

2. The lethal means reduction bulleted script FSN group (n=10) will:

   1. Participate in a 15-minute conversation about lethal means reduction in their home, emphasizing that 10-minutes can save a life - the conversation includes discussing locations and storage of firearms, ammo, medications, and location of mental health crisis resources.
   2. 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.)
   3. Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
   4. 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.

3. The general firearm safety intervention group (n=10) will:

   1. Participate in a 10-minute conversation about safe firearm storage in their home including discussing locations and storage of firearms and ammo.
   2. Pick out safe storage devices to take home (e.g. trigger locks, cable locks, ammo boxes, local safety resources, etc.)
   3. Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
   4. 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.

   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.

4. The general firearm safety comparison group (n=10) will:

   1. Pick out safe storage devices to take home (e.g. trigger locks, cable locks, ammo boxes, local safety resources, etc.)
   2. Be told about the next steps of the study, including a follow-up survey and interview in about 4 weeks.

All participants will be compensated for their time taking the baseline survey, regardless of group assignment.

• Participants will receive two RDS coupons at the end of their session to give to people in the community who they think would qualify and like to participate.
• The participants are instructed to check back in at the end of the day or later in the week to verify if either of the people they gave coupons to came in and participated.

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Kotzebue, Alaska, United States, 99752
      • Maniilaq Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults (over 18) who:

  • lives in the region,
  • Read and Understand English,
  • Live in a household with at least one gun,
  • Have a phone that can receive texts,
  • Lives in a household where young people (under 29) spend time

Exclusion Criteria:

• Someone else in the household has already participated in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FSN Lethal Means Scripted Intervention; 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).	Behavioral: Scripted FSN - Lethal Means Reduction; Scripted lethal means reduction, firearm storage supplies, tailored text messages; Participate in a 10-15-minute scripted session focused on gun safety and lethal means reduction; Be offered to home gun safety and lethal means reduction materials, including trigger locks, cable locks, ammo boxes, medication boxes and mental health resources; Receive 4 weeks of tailored text message reminders and encouragement
Active Comparator: General Firearm Safety Comparison; Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions: In the past two months, has anyone in your household been going through a rough time?; In the past two months, has someone in your home seemed down, sad, or depressed?; Are you worried that someone in your home is at risk of suicide? Participants in the general safety condition were offered safe-storage resources.	Behavioral: General Firearm Comparison - General Firearm Safety; firearm storage supplies * Be offered to take home safe gun storage materials, including trigger locks, cable locks, and ammo boxes
Experimental: Experimental: FSN Lethal Means MI Counseling; 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).	Behavioral: MI FSN - Lethal Means Reduction; Motivational Interviewing lethal means reduction, firearm storage supplies, Tailored text messages; Participate in a 15-20-minute motivational interviewing (MI) session conducted by trained University of Michigan research staff focused on encouraging suicide lethal means; Be offered to take home gun safety and lethal means reduction materials, including trigger locks, cable locks, ammo boxes, medication boxes and mental health resources; Receive 4 weeks of tailored text message reminders and encouragement
Active Comparator: General Firearm Safety Intervention; Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions: In the past two months, has anyone in your household been going through a rough time?; In the past two months, has someone in your home seemed down, sad, or depressed?; Are you worried that someone in your home is at risk of suicide? 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.	Behavioral: General Firearm Safety Intervention - General Firearm Safety; General information on gun safety, firearm storage supplies, tailored text messages; Participate in a 10-minute scripted conversation about safe gun storage practice; Be offered to take home safe gun storage materials, including trigger locks, cable locks, and ammo boxes; Receive 4 weeks of tailored text message reminders and encouragement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Assessed at baseline and 6-week follow up; 6 week follow up reported

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH); Maniilaq Association
• Investigators: Principal Investigator: Lisa M Wexler, PhD, MSW, University of Michigan

Publications and helpful links

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Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Alaska Native; Suicide Prevention; Family Engagement; Firearm Storage
• Additional Relevant MeSH Terms: Wounds and Injuries; Behavioral Symptoms; Self-Injurious Behavior; Behavior; Accidental Injuries; Suicide Prevention; Suicide
• Other Study ID Numbers: HUM00225431; 1R61MH125757-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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