Family Safety Net - Aim 3: Randomized Control Trial

NCT05657119 | Active Not Recruiting DMC

• 1 other identifier: HUM00225431
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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).
• 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.
• 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.

Conditions

Suicide; Accidental Injuries; Firearm Injury

Keywords

Motivational Interviewing; Suicide Prevention; Alaska Native; Firearm Storage; Family Engagement

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Household Firearm Storage

  Through data collection, an average of 6 weeks

Study Arms (2)

FSN Lethal Means Reduction

EXPERIMENTAL

\* Participants will be screened into the lethal-means reduction-focused FSN program if they answer "yes" to one or more of the following questions: 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? Participants are then assigned to either the MI FSN intervention or the Scripted FSN intervention

Behavioral: MI FSN - Lethal Means Reduction; Behavioral: Scripted FSN - Lethal Means Reduction

General Firearm Safety Comparison

ACTIVE COMPARATOR

General Firearm Safety \* Participants will be screened into the general firearm safety arm of the program if they do not answer "yes" to any of the following questions: 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? Participants are then assigned to either the General Firearm Safety Intervention or General Firearm Comparison

Behavioral: General Firearm Safety Intervention - General Firearm Safety; Behavioral: General Firearm Comparison - General Firearm Safety

Interventions

MI FSN - Lethal Means Reduction BEHAVIORAL

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

FSN Lethal Means Reduction

Scripted FSN - Lethal Means Reduction BEHAVIORAL

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

FSN Lethal Means Reduction

General Firearm Safety Intervention - General Firearm Safety BEHAVIORAL

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 Safety Comparison

General Firearm Comparison - General Firearm Safety BEHAVIORAL

firearm storage supplies \* Be offered to take home safe gun storage materials, including trigger locks, cable locks, and ammo boxes

General Firearm Safety Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Someone else in the household has already participated in the study

Sponsors & Collaborators

• University of Michigan: lead
• Maniilaq Association: collaborator

Study Sites (1)

Maniilaq Association

Kotzebue, Alaska, 99752, United States

Location

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Related 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.

MeSH Terms

Conditions

Suicide; Accidental Injuries; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Wounds and Injuries

Study Officials

• Lisa M Wexler, PhD, MSW

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Social Work

Model Details: Using a parallel group design trial, our design considers the acceptability, feasibility and signals of impact of two different interventions: (1) the Family Safety Net for those whose household may benefit from lethal means reduction counseling due to having someone in their home who is struggling; and (2) a General Firearm Safety intervention for households with firearms who did not endorse an item on the family-focused mental health screening.

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 20, 2022
• Study Start: November 2, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)