Family Safety Net - Aim 3: Randomized Control Trial

Suicide Clinical Trial

— FSN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05657119
• Other study ID #: HUM00225431
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 these questions, they will be randomly assigned to one of the two FSN intervention groups (1 and 2 below).

• 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Firearm Injury
• Suicide
• Suicide Prevention
• Wounds and Injuries

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Maniilaq Association	Kotzebue	Alaska

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Maniilaq Association

Country where clinical trial is conducted

United States, 

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* Note: There are 112 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of FSN	The feasibility of the intervention will be tested by assessing the % of people who are eligible and agree (# agree/#eligible). The duration of each session will offer information about feasibility. We will also 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.	Through data collection, an average of 6 weeks
Primary	Acceptability of the intervention	Recorded FSN sessions will offer qualitative data about the acceptability of the intervention. Our analysis will capture instances within each session of acceptance through participants' willingness to discuss the connection between firearm or medication access and suicide risk; and curiosity or openness to learning about mental health resources. We will also make note of resistance (unacceptability), which likely include changes of subject, arguing and other 'avoidance talk'. We will consider the pattern of acceptability (and resistance) within each transcript. Across all FSN MI and script interventions, we will look for patterns of both acceptance and resistance to find trends in the data signaling the kinds of acceptable (and unacceptable) conversations within the FSN sessions.	Data collection for this aim will be done through data collection. Average 6 weeks
Primary	Acceptability of the intervention	FSN Follow-up Survey includes 4 items focused on participant satisfaction. Participants rank their favorite parts of the program and additionally, 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) The Family Safety Net helped me meet my needs. (3) I would recommend Family Safety Net to a friend or family member. 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.	Through data collection. Average of 6 weeks
Primary	Acceptability of the intervention	FSN Follow-up Semi-Structured Interview includes 6 items focused on participant satisfaction. Participants are asked how each of the items they took home worked for them as well as the following questions: (1) What did you like best about the session? (2) Did you talk to anyone about your experience with FSN? (3) What did you think about the text messages you received? (4) Now that you did the whole Family Safety Net - the session a month ago, bringing home some safety supplies, and receiving text messages for the last month, what do you think is the best part of the program? (5) What might make it even better? (6) Is there anything else you want to tell us about your experience?	Through data collection. Average of 6 weeks
Secondary	Household Firearm Storage	For each household firearm (up to five), the FSN Follow-up Survey asks them to characterize how that firearm is stored in their home today, indicating, "Yes", "No", or "Not Sure" for each home firearm. Questions for each firearm are: Is the firearm: (1) Stored in another's home for safety? (2) Locked with a cable or trigger lock? (3) In a locked gun safe/cabinet? (4) Unloaded? (5) Ammo stored away from the gun? (6) Ammo locked in an ammo box? (% 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 between groups.	Through data collection, an average of 6 weeks

External 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.