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

Sponsor

University of Michigan (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05657119

Collaborator

Maniilaq Association (Other)

Enrollment

Location

Arms

10.4

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this 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 feasible and acceptable in a primarily Alaska Native population in Northwest Alaska.

Intervention participants will complete:

Screening Survey - Every household will receive, one voucher that an adult may bring back to take the screening survey and be entered into the raffle.
Baseline Surveys - We will conduct surveys with individuals with at least one gun in their home and who answers "yes" to one of our seven mental health questions about someone else in their home:
Brief Motivational Interviewing (MI) session - Participants will receive a 20-minute session conducted by trained University of Michigan research staff to encourage firearm safe storage in participant homes.
Offering materials to take home - After the brief MI session, firearm safety items will be offered including trigger locks, cable locks, and ammo boxes. Additionally, items promoting mental health will also be available including Careline magnets, educational materials, flyers for upcoming parenting classes, etc.
4-weeks of text messages - Participants will receive text message reminders and encouragement will be tailored by survey responses and delivered between 2x and 4X weekly depending on the baseline survey responses.
1-month follow-up Qualtrics survey - The follow-up survey consists of the baseline survey + 9 satisfaction questions about the MI sessions, materials brought home, text messages received, and actions taken

Researchers will compare people from the same population to see if household firearm storage practices change because of the MI intervention and access to firearm safety devices.

Screening Survey - Every household will receive, one voucher that an adult may bring back to take the screening survey and be entered into the raffle.
Baseline Surveys - We will conduct surveys with individuals with at least one gun in their home:
Receive Information - The comparison arm will receive information on firearm safe storage and household safety.
Offering materials to take home - The comparison arm will receive the gun safety information and will be offered to take home a carbon monoxide detector and mental health information.
1-month follow-up Qualtrics survey - The follow-up survey consists of the baseline survey + 9 satisfaction questions about the MI sessions, materials brought home, text messages received, and actions taken

Condition or Disease	Intervention/Treatment	Phase
Suicide Accidental Injuries Firearm Injury	Behavioral: FSN Intervention Behavioral: Comparison	N/A

Detailed Description

The goal of this 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 feasible and acceptable in a primarily Alaska Native population in NW Alaska.
One adult per household within a community will fill out a very short questionnaire to check their eligibility to participate in the study. By coming to the community location and filling out a 5-minute screening survey, each participant will be entered into a raffle to receive a $500 drum of heating oil. Anyone who comes with a recruitment voucher will take a 5-minute Qualtrics survey on the iPad. The screening survey seeks to identify those who meet our eligibility criteria.
The screening survey will link to a consent form with a unique identifier if the person is eligible to participate in the study. Research staff will confirm eligibility criteria and go through the consent form on the iPad and answer the participant's questions. If they agree to participate, they will mark their consent and be randomly assigned to the comparison or intervention group.
When people agree to participate in either group, they will be asked to complete a 10-15-minute baseline survey independently on the iPad.
After participants complete the baseline survey, then the interventionist will facilitate the 10-15-minute baseline structured interview.

For intervention group participants, they will participate in a short 20-30-minute motivational interviewing (MI) session that includes:

introduction to the session and setting the agenda;
discussing the person's goals and strengths related to keeping loved ones safe through safe firearm 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);
offering normative feedback about safe firearm storage practices within the community;
talk about the benefits of safer firearm storage practices (e.g. enhancing youth safety or avoiding youth harm);
action planning to increase self-efficacy to overcome barriers and move toward reducing access to firearms by locking and unloading all household guns;
offering ideas about the importance of supporting others in 'non-demanding' ways;
Action planning to brainstorm ways of supporting others in the household in non-demanding ways;
picking out safe storage devices to take home as 'cues for action' (e.g., magnets, trigger locks, cable locks, medicine boxes, etc); and
picking out wellness resources (e.g., mental health resources magnets, You Matter cards, sweets to share, local resource information, etc.);
summarizing key content of the session to re-enforce benefits, goals and values and support self-efficacy to facilitate safe firearm storage practices and wellness support at home. Depending on the participant's interests and goals, this MI session will focus on safe firearm storage, supporting others in their household's mental wellness or both.

Receive 4-weeks of text messages tailored by their survey responses (1x to 4x weekly depending on baseline survey and baseline structured interview responses). They may opt out at any time.
One month after the initial session, for both comparison and intervention groups, 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 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, those who did the FSN 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. Additionally, participants will have the opportunity to take the Follow-Up Survey in-person on an iPad with the research team and will be informed ahead of time about day, time, and location the research team will be available.

Researchers will compare people from the same population to see if household firearm storage practices change because of the MI intervention and access to firearm safety devices.

Comparison group:

When people agree to participate and are randomly assigned to the comparison group, they will be asked to complete a 10-15-minute baseline survey independently on the iPad.
After participants complete the baseline survey, then the interventionist will facilitate the 10-15-minute baseline structured interview.
Participate in a home safety discussion and take home a carbon monoxide detector, a carbon monoxide info sheet, a gun storage pamphlet, and a mental health resource magnet.
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 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, those who did the FSN 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. Additionally, participants will have the opportunity to take the Follow-Up Survey in-person on an iPad with the research team and will be informed ahead of time about day, time, and location the research team will be available.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FSN Intervention Participate in a short 20-30-minute motivational interviewing (MI) session that discusses the person's goals and strengths related to keeping loved ones safe through safe firearm 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), about the benefits of safer firearm storage practices (e.g. enhancing youth safety or avoiding youth harm), and then picking out safe storage devices and wellness resources to take home as 'cues for action'. Receive 4-weeks of text messages tailored by their survey responses (1x to 4x weekly depending on baseline survey and baseline structured interview responses). They may opt out at any time.	Behavioral: FSN Intervention Motivational Interviewing, firearm storage supplies, mental health wellness information
Active Comparator: Comparison Participate in a home safety discussion and take home a carbon monoxide detector, a carbon monoxide info sheet, a gun storage pamphlet, and a mental health resource magnet.	Behavioral: Comparison Safe home information, carbon monoxide information, carbon monoxide detector

Arm

Intervention/Treatment

Experimental: FSN Intervention

Participate in a short 20-30-minute motivational interviewing (MI) session that discusses the person's goals and strengths related to keeping loved ones safe through safe firearm 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), about the benefits of safer firearm storage practices (e.g. enhancing youth safety or avoiding youth harm), and then picking out safe storage devices and wellness resources to take home as 'cues for action'. Receive 4-weeks of text messages tailored by their survey responses (1x to 4x weekly depending on baseline survey and baseline structured interview responses). They may opt out at any time.

Behavioral: FSN Intervention

Motivational Interviewing, firearm storage supplies, mental health wellness information

Active Comparator: Comparison

Participate in a home safety discussion and take home a carbon monoxide detector, a carbon monoxide info sheet, a gun storage pamphlet, and a mental health resource magnet.

Behavioral: Comparison

Safe home information, carbon monoxide information, carbon monoxide detector

Outcome Measures

Primary Outcome Measures

Feasibility of FSN [Through study completion, an average of 6 weeks]
The feasibility of the intervention will be tested by assessing the % of people who are eligible and agree (# agree/# eligible). For feasibility, we will consider the level of attrition over the 4-week booster period, and the ability to collect follow-up data (target: 85% or 60 people) to assess participant satisfaction.
Acceptability of the intervention [Through study completion, an average of 6 weeks]
FSN Follow-up Survey includes 8 items focused on participant satisfaction. Participants indicate, with a 10 point Likert Scale, how much they agree with the following statements: (1) I am glad I participated in the Family Safety Net. (2) Family Safety Net is a respectful way to increase home safety. (3) I would recommend Family Safety Net to a friend or family member. (4) The information about home safety was valuable to me. (5) I liked getting texts from the Family Safety Net team.(6) The gun safety materials I got from the Family Safety Net worked well for me.(7) The ideas for how I can support young people's mental wellness were valuable to me. (8) The medication storage containers worked well for me. Answers will be aggregated for each item and overall. Items with an average 5.5 or more will be considered acceptable, and the intervention overall will be assessed by measurement average for all acceptability-related items of 5.5 or more.

Secondary Outcome Measures

Household Firearm Storage [Through study completion, an average of 6 weeks]
For each household firearm, the FSN Follow-up Survey asks them to characterize how that firearm is stored in their home today, 'checking all that apply' for each home firearm. Answer categories for each firearm are: 1=In a locked room; 2=Locked with a cable or trigger lock; 3=In a locked gun safe/cabinet; 4=On a gun rack; 5=In a hard to reach place (ex: under the bed, in a closet); 6=Unloaded; 7= Ammo stored away from gun(s); 8=Ammo locked in an ammo box?; 9=Other, please specify. Analyses include baseline and follow-up within person change over time for each safe storage item (locked/unlocked (items #2 or #3); unloaded/loaded (#6); ammo near/far (#7) and locked/unlocked ammo (#8) (% baseline/% follow-up). We aim to answer how many (%) people went from storing firearms 'less safely' (e.g. unlocked) at baseline to more safely (e.g. locked) at follow-up, comparing results from the intervention and comparison groups.