Maniilaq Association
Kotzebue, Alaska, 99752, United States
NCT Number: NCT05657119
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kotzebue, Alaska, 99752, United States
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:
They are then randomly assigned into one of two groups using a grouped randomization table:
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.
All participants will be compensated for their time taking the baseline survey, regardless of group assignment.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Motivational Interviewing lethal means reduction, firearm storage supplies, Tailored text messages
Scripted lethal means reduction, firearm storage supplies, tailored text messages
General information on gun safety, firearm storage supplies, tailored text messages
firearm storage supplies
Time frame: Baseline
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.
Time frame: Assessed at 6 week follow up
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.
Time frame: Assessed at 6 week follow up
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.
Time frame: Assessed at baseline and 6-week follow up; 6 week follow up reported
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.
University of Michigan
Other
Family Safety Net: Developing an Upstream Suicide Prevention Approach to Encourage Safe Firearm Storage in Rural and Remote
Acronym: FSN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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