Family Safety Net - Aim 3: Randomized Control Trial

NCT05657119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-19

Study results available
· View outcomes & findings →

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 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.

Conditions

  • Suicide
  • Accidental Injuries
  • Firearm Injury

Interventions

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

BEHAVIORAL

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

BEHAVIORAL

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

BEHAVIORAL

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

Sponsors & Collaborators

  • Maniilaq Association

    collaborator UNKNOWN
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Michigan

    lead OTHER

Principal Investigators

  • Lisa M Wexler, PhD, MSW · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2024-06-30
Completion
2025-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657119 on ClinicalTrials.gov