Trial Outcomes & Findings for Family Safety Net - Aim 3: Randomized Control Trial (NCT NCT05657119)
NCT ID: NCT05657119
Last Updated: 2026-05-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline
Results posted on
2026-05-19
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
General Firearm Safety Comparison
Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes.
|
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).
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
21
|
10
|
19
|
|
Overall Study
COMPLETED
|
8
|
21
|
10
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis includes only information from participants who completed both baseline and follow-up surveys
Baseline characteristics by cohort
| Measure |
FSN Lethal Means MI Counseling
n=10 Participants
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).
|
FSN Lethal Means Scripted Intervention
n=8 Participants
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 Intervention
n=19 Participants
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.
|
General Firearm Safety Comparison
n=21 Participants
Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 18.8 • n=10 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
39.75 years
STANDARD_DEVIATION 13.85 • n=8 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
47.53 years
STANDARD_DEVIATION 17.39 • n=19 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
41.29 years
STANDARD_DEVIATION 16.65 • n=21 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
42.72 years
STANDARD_DEVIATION 16.75 • n=58 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
3 Participants
n=8 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
7 Participants
n=19 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
8 Participants
n=21 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
22 Participants
n=58 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
5 Participants
n=8 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
12 Participants
n=19 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
13 Participants
n=21 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
36 Participants
n=58 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
19 Participants
n=19 Participants
|
18 Participants
n=21 Participants
|
55 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=10 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
8 Participants
n=8 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
19 Participants
n=19 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
21 Participants
n=21 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
58 Participants
n=58 Participants • Analysis includes only information from participants who completed both baseline and follow-up surveys
|
|
Household Firearm Storage
|
2.18 units on a scale
STANDARD_DEVIATION 0.47 • n=9 Participants • Analysis includes only information from participants who reported having one or more firearms in their home.
|
2.78 units on a scale
STANDARD_DEVIATION 0.64 • n=8 Participants • Analysis includes only information from participants who reported having one or more firearms in their home.
|
2.53 units on a scale
STANDARD_DEVIATION 0.91 • n=18 Participants • Analysis includes only information from participants who reported having one or more firearms in their home.
|
2.83 units on a scale
STANDARD_DEVIATION 0.79 • n=21 Participants • Analysis includes only information from participants who reported having one or more firearms in their home.
|
2.62 units on a scale
STANDARD_DEVIATION 0.79 • n=56 Participants • Analysis includes only information from participants who reported having one or more firearms in their home.
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
General Firearm Safety Comparison
Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes.
|
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.
|
FSN Lethal Means Intervention
n=19 Participants
The two FSN conditions were: (1) a scripted counseling session, delivered by all members of the research team, and (2) a motivational interviewing (MI) brief counseling session, delivered by a Master's-level social worker. Due to the limited feasibility of implementing a large-scale MI intervention done by a Masters-level social worker in a remote area, a less resource-intensive scripted session was tested for comparable acceptability. Participants in both FSN conditions directly addressed the connection between an identified 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. Both FSN interventions (MI counseling and scripted) asked participants to reflect on specific ways they can keep their loved one safe, however, the MI session asked broader open-ended questions about what that person might do to increase environmental safety in their home, while the scripted session uses a handout with an image of a typical home for participants to walk through and discuss where and how their firearms, ammunition, and medications are stored, emphasizing that "10 minutes can save a life" and encouraging them to display mental health resources in the home. At the end of the session, participants in both sessions were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line.
|
General Firearm Safety Comparison
n=43 Participants
Participants who did not endorse any of the three screening items indicating concern for a household member were randomized to one of two general safety conditions: (1) a scripted general safety session encouraging locking and unloading firearms at home, and offering firearm safe-storage resources, and (2) offering safe-storage resources only.
|
|---|---|---|---|---|
|
Feasibility of the Intervention
|
—
|
—
|
18 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 week follow upParticipants 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.
Outcome measures
| Measure |
General Firearm Safety Comparison
n=19 Participants
Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes.
|
General Firearm Safety Intervention
n=21 Participants
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.
|
FSN Lethal Means Intervention
n=10 Participants
The two FSN conditions were: (1) a scripted counseling session, delivered by all members of the research team, and (2) a motivational interviewing (MI) brief counseling session, delivered by a Master's-level social worker. Due to the limited feasibility of implementing a large-scale MI intervention done by a Masters-level social worker in a remote area, a less resource-intensive scripted session was tested for comparable acceptability. Participants in both FSN conditions directly addressed the connection between an identified 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. Both FSN interventions (MI counseling and scripted) asked participants to reflect on specific ways they can keep their loved one safe, however, the MI session asked broader open-ended questions about what that person might do to increase environmental safety in their home, while the scripted session uses a handout with an image of a typical home for participants to walk through and discuss where and how their firearms, ammunition, and medications are stored, emphasizing that "10 minutes can save a life" and encouraging them to display mental health resources in the home. At the end of the session, participants in both sessions were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line.
|
General Firearm Safety Comparison
n=8 Participants
Participants who did not endorse any of the three screening items indicating concern for a household member were randomized to one of two general safety conditions: (1) a scripted general safety session encouraging locking and unloading firearms at home, and offering firearm safe-storage resources, and (2) offering safe-storage resources only.
|
|---|---|---|---|---|
|
Participant Agreement With the Statement: "I am Glad I Participated in the Family Safety Net"
|
9.63 score on a scale
Standard Deviation 0.9
|
9.95 score on a scale
Standard Deviation 0.22
|
9.1 score on a scale
Standard Deviation 1.91
|
9.88 score on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: Assessed at 6 week follow upParticipants 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.
Outcome measures
| Measure |
General Firearm Safety Comparison
n=19 Participants
Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes.
|
General Firearm Safety Intervention
n=21 Participants
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.
|
FSN Lethal Means Intervention
n=10 Participants
The two FSN conditions were: (1) a scripted counseling session, delivered by all members of the research team, and (2) a motivational interviewing (MI) brief counseling session, delivered by a Master's-level social worker. Due to the limited feasibility of implementing a large-scale MI intervention done by a Masters-level social worker in a remote area, a less resource-intensive scripted session was tested for comparable acceptability. Participants in both FSN conditions directly addressed the connection between an identified 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. Both FSN interventions (MI counseling and scripted) asked participants to reflect on specific ways they can keep their loved one safe, however, the MI session asked broader open-ended questions about what that person might do to increase environmental safety in their home, while the scripted session uses a handout with an image of a typical home for participants to walk through and discuss where and how their firearms, ammunition, and medications are stored, emphasizing that "10 minutes can save a life" and encouraging them to display mental health resources in the home. At the end of the session, participants in both sessions were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line.
|
General Firearm Safety Comparison
n=8 Participants
Participants who did not endorse any of the three screening items indicating concern for a household member were randomized to one of two general safety conditions: (1) a scripted general safety session encouraging locking and unloading firearms at home, and offering firearm safe-storage resources, and (2) offering safe-storage resources only.
|
|---|---|---|---|---|
|
Participant Agreement With the Statement: "I Would Recommend the Family Safety Net"
|
9.63 score on a scale
Standard Deviation 1.11
|
9.9 score on a scale
Standard Deviation 0.44
|
8.9 score on a scale
Standard Deviation 1.91
|
9.63 score on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Assessed at baseline and 6-week follow up; 6 week follow up reportedPopulation: 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.
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.
Outcome measures
| Measure |
General Firearm Safety Comparison
n=17 Participants
Participants in the general safety condition were offered safe-storage resources, including trigger locks, cable locks, and ammo boxes.
|
General Firearm Safety Intervention
n=16 Participants
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.
|
FSN Lethal Means Intervention
n=8 Participants
The two FSN conditions were: (1) a scripted counseling session, delivered by all members of the research team, and (2) a motivational interviewing (MI) brief counseling session, delivered by a Master's-level social worker. Due to the limited feasibility of implementing a large-scale MI intervention done by a Masters-level social worker in a remote area, a less resource-intensive scripted session was tested for comparable acceptability. Participants in both FSN conditions directly addressed the connection between an identified 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. Both FSN interventions (MI counseling and scripted) asked participants to reflect on specific ways they can keep their loved one safe, however, the MI session asked broader open-ended questions about what that person might do to increase environmental safety in their home, while the scripted session uses a handout with an image of a typical home for participants to walk through and discuss where and how their firearms, ammunition, and medications are stored, emphasizing that "10 minutes can save a life" and encouraging them to display mental health resources in the home. At the end of the session, participants in both sessions were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line.
|
General Firearm Safety Comparison
n=7 Participants
Participants who did not endorse any of the three screening items indicating concern for a household member were randomized to one of two general safety conditions: (1) a scripted general safety session encouraging locking and unloading firearms at home, and offering firearm safe-storage resources, and (2) offering safe-storage resources only.
|
|---|---|---|---|---|
|
Household Firearm Storage
|
3.45 score on a scale
Standard Deviation 0.73 • Interval 0.22 to 1.18
|
3.74 score on a scale
Standard Deviation 0.52 • Interval 0.76 to 1.6
|
3.46 score on a scale
Standard Deviation 0.8 • Interval 0.26 to 2.25
|
3.96 score on a scale
Standard Deviation 0.09 • Interval 0.58 to 18.5
|
Adverse Events
FSN Lethal Means MI Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FSN Lethal Means Scripted Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Firearm Safety Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Firearm Safety Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Wexler, Research Professor, Institute for Social Research
University of Michigan
Phone: 7347647806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place