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NCT05657119 · ClinicalTrials.gov registry record · NA

Family Safety Net - Aim 3: Randomized Control Trial

A NA study of Suicide and Firearm Injury, sponsored by University of Michigan.

Active
Registry status
NA
Development phase
86
Enrollment target
1
Study location

NCT05657119 is a NA study of Suicide and Firearm Injury that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 86 participants, below the 6,989-participant average among 92 other Suicide trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05657119, a NA study of Suicide and Firearm Injury, is active but no longer recruiting, sponsored by University of Michigan.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
86 participants
Enrollment target
1
Study location

Study 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 s

Interventions

  • BEHAVIORAL MI FSN - Lethal Means Reduction
  • BEHAVIORAL Scripted FSN - Lethal Means Reduction
  • BEHAVIORAL General Firearm Safety Intervention - General Firearm Safety
  • BEHAVIORAL General Firearm Comparison - General Firearm Safety

Study Locations (1)

Alaska

  • Maniilaq Association - Kotzebue

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2022-11-02
Est. Completion 2025-12-30
Phase NA

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT05657119

The ClinicalTrials.gov registry entry for NCT05657119 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,989-participant average among 92 other Suicide trials with a reported enrollment target (99% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Suicide appearing as the primary indexed condition, and to 4 interventions - of which MI FSN - Lethal Means Reduction is the first listed.

NCT05657119 reports 1 study location spanning 1 distinct geographic area - top geographies include Alaska.

Frequently Asked Questions

What is clinical trial NCT05657119 about?

NCT05657119 is a clinical study titled "Family Safety Net - Aim 3: Randomized Control Trial". 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 Scripte...

What is the current status of trial NCT05657119?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2022-11-02. Estimated completion is 2025-12-30.

What conditions does trial NCT05657119 study?

This clinical trial studies the following conditions: Suicide, Firearm Injury, Accidental Injuries.

What interventions are being tested in trial NCT05657119?

The interventions under investigation include: MI FSN - Lethal Means Reduction (BEHAVIORAL), Scripted FSN - Lethal Means Reduction (BEHAVIORAL), General Firearm Safety Intervention - General Firearm Safety (BEHAVIORAL), General Firearm Comparison - General Firearm Safety (BEHAVIORAL).

Who is sponsoring clinical trial NCT05657119?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05657119 being conducted?

This trial has 1 study location across Alaska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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