Family Safety Net: Developing an Upstream Suicide Prevention Approach to Encourage Safe Firearm Storage in Rural and Remote
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Feasibility of FSN
研究概览
简要总结
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).
- 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.
- 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.
详细描述
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:
- Are 18 or older
- Live in a home with at least one firearm
- Live in a home where young people (under 29) spend time
- Live in the region
- Are the only person from their household to participate in the study
- 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:
- In the past two months, has anyone in your household been going through a rough time?
- In the past two months, has someone in your home seemed down, sad, or depressed?
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Someone else in the household has already participated in the study
研究组 & 干预措施
General Firearm Safety Comparison
Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions:
- In the past two months, has anyone in your household been going through a rough time?
- In the past two months, has someone in your home seemed down, sad, or depressed?
- Are you worried that someone in your home is at risk of suicide? Participants in the general safety condition were offered safe-storage resources.
干预措施: General Firearm Comparison - General Firearm Safety (Behavioral)
FSN Lethal Means Scripted Intervention
Participants 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).
干预措施: Scripted FSN - Lethal Means Reduction (Behavioral)
Experimental: FSN Lethal Means MI Counseling
Participants 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).
干预措施: MI FSN - Lethal Means Reduction (Behavioral)
General Firearm Safety Intervention
Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions:
- In the past two months, has anyone in your household been going through a rough time?
- In the past two months, has someone in your home seemed down, sad, or depressed?
- 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.
干预措施: General Firearm Safety Intervention - General Firearm Safety (Behavioral)
结局指标
主要结局
Feasibility of FSN
时间窗: Through data collection, 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). 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.
Acceptability of the intervention
时间窗: Through data collection. Average of 6 weeks
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.
Feasibility of the Intervention
时间窗: 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.
Participant Agreement With the Statement: "I am Glad I Participated in the Family Safety Net"
时间窗: 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.
Participant Agreement With the Statement: "I Would Recommend the Family Safety Net"
时间窗: 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.
次要结局
- Household Firearm Storage(Through data collection, an average of 6 weeks)
- Household Firearm Storage(Assessed at baseline and 6-week follow up; 6 week follow up reported)
研究者
Lisa Wexler
Professor of Social Work
University of Michigan