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SuicideFSNNCT05657119

Family Safety Net - Aim 3: Randomized Control Trial

A study testing MI FSN - Lethal Means Reduction, Scripted FSN - Lethal Means Reduction and General Firearm Safety Intervention - General Firearm Safety in people with Suicide and Accidental Injuries, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Suicide, Accidental Injuries, Firearm Injury
What is being tested?
MI FSN - Lethal Means Reduction, Scripted FSN - Lethal Means Reduction and General Firearm Safety Intervention - General Firearm Safety
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
2 Nov 2022to 30 Dec 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Maniilaq Association

    Kotzebue, Alaska, 99752

Other trials in United States

About this study

Official title: 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?
Read more

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.
  1. General gun safety comparison group:
  • Can take home trigger locks, cable locks, and ammo boxes.
  • Complete 1-month follow-up survey.
Read the 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:
  2. Participate in a short 20-minute motivational interviewing (MI) session that includes:
  3. introduction to the session and setting the agenda;
  4. 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);
  5. offering normative feedback about safe firearm storage practices within the community;
  6. talk about the benefits of safer firearm and medication storage practices (e.g. enhancing youth safety or avoiding youth harm);
  7. 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
  8. 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.
  9. 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.)
  10. Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
  11. 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.
  12. The lethal means reduction bulleted script FSN group (n=10) will:
  13. 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.
  14. 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.)
  15. Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
  16. 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.
  17. The general firearm safety intervention group (n=10) will:
  18. Participate in a 10-minute conversation about safe firearm storage in their home including discussing locations and storage of firearms and ammo.
  19. Pick out safe storage devices to take home (e.g. trigger locks, cable locks, ammo boxes, local safety resources, etc.)
  20. Be told about the next steps of the study, including text messages, and follow-up survey and interview in about 4 weeks.
  21. 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.
  22. The general firearm safety comparison group (n=10) will:
  23. Pick out safe storage devices to take home (e.g. trigger locks, cable locks, ammo boxes, local safety resources, etc.)
  24. 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.

Being tested
MI FSN - Lethal Means Reduction, Scripted FSN - Lethal Means Reduction, General Firearm Safety Intervention - General Firearm Safety, General Firearm Comparison - General Firearm Safety
Keywords
Motivational Interviewing, Suicide Prevention, Alaska Native, Firearm Storage, Family Engagement
Medical subject headings
Suicide, Accidental Injuries, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MI FSN - Lethal Means ReductionBehavioural

    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
  • Scripted FSN - Lethal Means ReductionBehavioural

    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
  • General Firearm Safety Intervention - General Firearm SafetyBehavioural

    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
  • General Firearm Comparison - General Firearm SafetyBehavioural

    firearm storage supplies

    • Be offered to take home safe gun storage materials, including trigger locks, cable locks, and ammo boxes
Study groups in NCT05657119
Study groupRoleWhat they receive
FSN Lethal Means Scripted InterventionExperimentalParticipants 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).
Receives: Behavioral: Scripted FSN - Lethal Means Reduction
General Firearm Safety ComparisonActive comparatorParticipants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions: 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? Participants in the general safety condition were offered safe-storage resources.
Receives: Behavioral: General Firearm Comparison - General Firearm Safety
Experimental: FSN Lethal Means MI CounselingExperimentalParticipants 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).
Receives: Behavioral: MI FSN - Lethal Means Reduction
General Firearm Safety InterventionActive comparatorParticipants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions: 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? 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.
Receives: Behavioral: General Firearm Safety Intervention - General Firearm Safety

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Assessed at 6 week follow up

  3. 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.

    Measured: Assessed at 6 week follow up

Secondary outcomes (1)
  1. 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.

    Measured: Assessed at baseline and 6-week follow up; 6 week follow up reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start2 Nov 2022
  3. Primary completion30 Jun 2024
  4. Study completion30 Dec 2025

Resources

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
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.
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05657119
Sponsor's protocol ID
HUM00225431
Other IDs
1R61MH125757-01
Acronym
FSN
Status last verified
Mar 2026
First submitted
1 Dec 2022
Last updated
19 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29879094
  • Blake I, Holck P, Provost EM. Alaska native mortality update: 2009-2013. Alsk Native Epidemiol. Published online 2016.

  • Parker K. Alaska Trauma Registry. Trauma Admissions Involving Firearms; 2016.

  • Anglemyer A, Horvath T, Rutherford G. The accessibility of firearms and risk for suicide and homicide victimization among household members: a systematic review and meta-analysis. Ann Intern Med. 2014 Jan 21;160(2):101-10. doi: 10.7326/M13-1301.

    PubMed 24592495
  • Horn A, Grossman DC, Jones W, Berger LR. Community based program to improve firearm storage practices in rural Alaska. Inj Prev. 2003 Sep;9(3):231-4. doi: 10.1136/ip.9.3.231.

    PubMed 12966011
  • Grossman DC, Stafford HA, Koepsell TD, Hill R, Retzer KD, Jones W. Improving firearm storage in Alaska native villages: a randomized trial of household gun cabinets. Am J Public Health. 2012 May;102 Suppl 2(Suppl 2):S291-7. doi: 10.2105/AJPH.2011.300421. Epub 2012 Mar 8.

    PubMed 22401514
  • Crosby AE, Ortega L, Stevens MR; Centers for Disease Control and Prevention (CDC). Suicides - United States, 2005-2009. MMWR Suppl. 2013 Nov 22;62(3):179-83.

    PubMed 24264512
  • Alaska bureau of vital statistics. Data and Statistics.; 2016.

  • Collins PY, Delgado RA, Pringle BA, Roca C, Phillips A. Suicide prevention in Arctic Indigenous communities. Lancet Psychiatry. 2017 Feb;4(2):92-94. doi: 10.1016/S2215-0366(16)30349-2. No abstract available.

    PubMed 28137384
  • Yip PS, Caine E, Yousuf S, Chang SS, Wu KC, Chen YY. Means restriction for suicide prevention. Lancet. 2012 Jun 23;379(9834):2393-9. doi: 10.1016/S0140-6736(12)60521-2.

    PubMed 22726520
  • Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Hoschl C, Barzilay R, Balazs J, Purebl G, Kahn JP, Saiz PA, Lipsicas CB, Bobes J, Cozman D, Hegerl U, Zohar J. Suicide prevention strategies revisited: 10-year systematic review. Lancet Psychiatry. 2016 Jul;3(7):646-59. doi: 10.1016/S2215-0366(16)30030-X. Epub 2016 Jun 8.

    PubMed 27289303
  • van der Feltz-Cornelis CM, Sarchiapone M, Postuvan V, Volker D, Roskar S, Grum AT, Carli V, McDaid D, O'Connor R, Maxwell M, Ibelshauser A, Van Audenhove C, Scheerder G, Sisask M, Gusmao R, Hegerl U. Best practice elements of multilevel suicide prevention strategies: a review of systematic reviews. Crisis. 2011;32(6):319-33. doi: 10.1027/0227-5910/a000109.

    PubMed 21945840
  • Barber CW, Miller MJ. Reducing a suicidal person's access to lethal means of suicide: a research agenda. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S264-72. doi: 10.1016/j.amepre.2014.05.028.

    PubMed 25145749
  • Strayer H, Craig J, Asay E, Haakenson A, Provost E. Alaska Native injury atlas: An update. In: Center IPPaANE, ed. 2014. Alaska Native Tribal Health Consortium; 2014.

  • Ngo QM, Sigel E, Moon A, Stein SF, Massey LS, Rivara F, King C, Ilgen M, Cunningham R, Walton MA; FACTS Consortium. State of the science: a scoping review of primary prevention of firearm injuries among children and adolescents. J Behav Med. 2019 Aug;42(4):811-829. doi: 10.1007/s10865-019-00043-2. Epub 2019 Aug 1.

    PubMed 31367940

Questions about this trial

What is this clinical trial studying?

A study testing MI FSN - Lethal Means Reduction, Scripted FSN - Lethal Means Reduction and General Firearm Safety Intervention - General Firearm Safety in people with Suicide and Accidental Injuries, run by University of Michigan at 1 site 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 19 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 1 site 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?

Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Intervention (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05657119, which also lists 112 linked publications.

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 19 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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