NCT03835585

Brief Summary

This study compares the effectiveness of two interventions for suicide over the course of a month. The experimental intervention includes the provision of a gun lock with video instructions, in addition to standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, and lethal means counseling). The comparison intervention group will receive the same standard suicide risk interventions without the gun lock and video. The targeted outcome will be level of engagement in gun safety behaviors (e.g., using a gun lock, using a gun safe, considering getting rid of guns). It is predicted that the experimental intervention will result in greater increases over time in engagement in gun safety behaviors, as compared to the comparison intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

2.4 years

First QC Date

February 4, 2019

Last Update Submit

April 6, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Engagement in Firearm Safety Behaviors

    This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")

    Immediately prior to intervention

  • Engagement in Firearm Safety Behaviors

    This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")

    Two weeks after intervention

  • Engagement in Firearm Safety Behaviors

    This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")

    One month after intervention

Secondary Outcomes (8)

  • Intentions to Adhere to Clinician Recommendations

    Immediately prior to Intervention

  • Intentions to Adhere to Clinician Recommendations

    Immediately after intervention

  • Intentions to Adhere to Clinician Recommendations

    Two weeks after intervention

  • Intentions to Adhere to Clinician Recommendations

    One month after intervention

  • Acceptability of Intervention

    Immediately prior to intervention

  • +3 more secondary outcomes

Study Arms (2)

Gun lock

EXPERIMENTAL

Participants will be provided a gun lock and video instructions for its proper use, in addition to standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling).

Device: Gun lockOther: Suicide Risk AssessmentBehavioral: Safety PlanningBehavioral: Lethal Means Counseling

Standard intervention

ACTIVE COMPARATOR

Participants will be provided standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling) without a gun lock. A gun lock and video instructions will be provided upon completion of the study.

Other: Suicide Risk AssessmentBehavioral: Safety PlanningBehavioral: Lethal Means Counseling

Interventions

Gun lockDEVICE

A cable-style gun lock that can be applied to a wide variety of guns for safe storage. The application of this device to most firearms renders them impossible to use properly while the device is in place and locked.

Gun lock

Thorough suicide risk assessment according to guidelines established by research (Joiner et al., 1999; Chu et al., 2015). This is used to determine the severity of suicide risk and appropriate actions to be taken.

Gun lockStandard intervention
Safety PlanningBEHAVIORAL

A psychological intervention for suicide risk that is based on research (Chu et al., 2015; Stanley \& Brown, 2012). This involves listing the following on an index card: activities individuals can use to feel better during a crisis, contact numbers that are important to the individuals, emergency options that are always accessible, and reasons for living. Although the individualized nature of safety plans does not allow for a scripted/uniform approach, for this study they will all include 8 steps and steps 5-8 (emergency options) will be the same for each individual.

Gun lockStandard intervention

A psychological intervention for suicide risk that is based on research (Bryan et al., 2011; Chu et al., 2015; Rudd, 2006; Stanley, 2018). This involves a psychological clinician discussing, with an at-risk individual, the importance for increasing the distance/obstacles between the individual at risk for suicide and specific types of lethal means. In the present study, the lethal means targeted was firearms and the lethal means counseling approach was able to be standardized/scripted as has been done in previous research (see Stanley, 2018).

Gun lockStandard intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must own and have access to a firearm
  • Must have at least one lifetime episode of suicide ideation
  • Must be 18 years of age or older

You may not qualify if:

  • \- May not be under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Thomas E Joiner, PhD

    Robert O. Lawton Distinguished Professor

    STUDY DIRECTOR
  • Bruno Chiurliza, MS

    Graduate Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants are informed that the purpose of the study is to "test the effects that providing gun locks as part of a psychological intervention has on gun safety behaviors" and that there are two treatment groups and that one is a "gun lock" group and that one is "standard intervention" group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Experimental group and comparison group measured immediately prior to intervention, immediately after intervention, 2 weeks after intervention, and one month after intervention. Analyses conducted will be Repeated Measures Analysis of Variance (RM-ANOVA).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 8, 2019

Study Start

November 1, 2019

Primary Completion

April 2, 2022

Study Completion

April 2, 2022

Last Updated

April 8, 2022

Record last verified: 2022-04

Locations