Project Safe Guard-Trauma (PSG-T)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Firearm Injury; Suicide Prevention; PTSD; Firearm Safety

Treatments: Behavioral: Project Safe Guard; Behavioral: Project Safe Guard - Trauma

Study type: Interventional

Funder types: Other

Identifiers

NCT06876740

HT9425-24-1-0693 (Other Grant/Funding Number)

24-1287

Details and patient eligibility

About

The goal of this randomized controlled trial is to determine if a counseling intervention, Project Safe Guard-Trauma (PSG-T), increases secure firearm storage practices in adults who screen positive for posttraumatic stress disorder (PTSD). The main questions this study aims to answer are:

• Does PSG-T lead to more secure firearm storage practices?
• Does PSG-T increase knowledge about the link between firearm storage practices and suicide risk?
• Does PSG-T increase intentions to store firearms securely?

Researchers will compare PSG-T to a control, Project Safe Guard (PSG), which is a counseling intervention that does not focus on the potential influence of PTSD symptoms on firearm storage practices. This will help to determine if PSG-T works better than PSG to increase secure firearm storage in adults with elevated PTSD symptoms.

Participants will:

• Complete a baseline survey
• Receive the counseling intervention
• Complete a survey immediately after the intervention and at 1-, 3-, and 6-months following the intervention

Full description

Firearms are the most common suicide method among service members, veterans, and civilians. Secure firearm storage reduces the risk of suicide. Lethal means safety counseling (LMSC) is an effective approach to promote secure firearm storage and, therefore, decrease the risk of suicide. Suicide risk is elevated among individuals with posttraumatic stress disorder (PTSD). PTSD affects safety perceptions and firearm storage practices. Current data indicate that the gold standard existing LMSC intervention - Project Safe Guard (PSG) - has reduced efficacy for individuals with elevated PTSD symptoms. Thus, there is a need to adapt LMSC for individuals with elevated PTSD symptoms.

Project Safe Guard-Trauma (PSG-T) is a brief LMSC intervention rooted in PSG principles but adapted specifically for firearm-owning individuals with PTSD. This study will evaluate the efficacy of PSG-T compared with control (standard PSG) in prompting more secure firearm storage behaviors. This study is a 2-arm randomized controlled trial. Participants will be randomized following the pre-intervention assessment. The participants will receive a single-session LMSC intervention, post-intervention assessment, and 1-, 3-, and 6- month follow-up assessments. The goal is to increase knowledge about the link between firearm storage practices and suicide risk, intentions to store firearms safely, and actual safer firearm storage behaviors.

Aim 1: To conduct a 2-armed randomized control trial to evaluate the efficacy of PSG-T compared with a control (PSG) in increasing knowledge about the link between firearm storage practices and suicide risk, intentions to store firearms safely, and actual safer firearm storage behaviors.

Hypothesis 1: Compared with PSG, at 1-, 3-, and 6-month follow-up, PSG-T will result in greater (a) knowledge about the link between firearm storage practices and suicide risk, (b) intentions to store firearms securely, and (c) actual more secure firearm storage behaviors (primary outcome at 6-month follow-up).

Aim 2: To evaluate differences in PTSD-related negative cognitions about the world as a potential mechanism of change in PSG-T for increasing knowledge, intentions, and behaviors regarding safe firearm storage practices.

Hypothesis 2: Participants who receive PSG-T will report fewer PTSD-related negative cognitions about the world compared with participants who receive PSG, and these decreases will be associated with increases in (a) knowledge about the link between firearm storage practices and suicide risk, (b) intentions to store firearms securely, and (c) actual more secure firearm storage behaviors.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18+ years
• Firearm owner
• History of one or more victimization traumas per the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (LEC-5), defined as having directly experienced physical assault, sexual assault, combat, and/or captivity
• Positive posttraumatic stress disorder (PTSD) screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
• Willing to provide physical location at time of Zoom sessions
• Willing to keep Zoom camera on during study sessions
• Ability to read, write, and speak English

Exclusion criteria

• Currently stores all personal firearms unloaded and locked
• Active psychosis or acute mania necessitating clinical intervention
• Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)
• Unable to provide informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Project Safe Guard - Trauma

Experimental group

Description:

Participants randomized into this arm will be offered Project Safe Guard-Trauma (PSG-T), which is a brief, single-session intervention designed to promote secure firearm storage practices among individuals with PTSD. Participants in this arm will also receive crisis response planning (CRP).

Treatment:

Behavioral: Project Safe Guard - Trauma

Project Safe Guard

Active Comparator group

Description:

Participants randomized into this arm will be offered Project Safe Guard (PSG), which is a brief, single-session intervention designed to promote secure firearm storage practices. Participants in this arm will also receive crisis response planning (CRP).

Treatment:

Behavioral: Project Safe Guard