Clinical trial NCT06876740: Project Safe Guard-Trauma
Official title: Project Safe Guard-Trauma (PSG-T): A Randomized Controlled Trial of Counseling to Promote a Secure Home Environment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Firearm Injury
Suicide Prevention
Firearm Safety
Keywords: PTSD
Firearm Injury
Suicide Prevention
Firearm safety
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who meet inclusion and exclusion criteria will be equally randomized between the two intervention conditions following the pre-intervention assessment. We will use computerized block randomization to allocate participants into either Project Safe Guard-Trauma or Project Safe Guard. Block randomization will vary by the number of participants in each block to ensure that the research staff cannot anticipate the next randomization, thereby reducing potential for bias. Biostatisticians will oversee randomization.
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Firearm Storage Practices
timeFrame: Baseline to 6-Month Follow-Up
Secondary outcomes:
measure: Knowledge of Firearm Storage Practices and Suicide Risk Link
timeFrame: Baseline to 6-Month Follow-Up
measure: Intentions to Securely Store Firearms
timeFrame: Baseline to 6-Month Follow-Up
measure: Posttraumatic Cognitions Inventory (PTCI) negative-world subscale
timeFrame: Baseline to 6-Month Follow-Up
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Baseline to 6-Month Follow-Up
measure: Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Illness-5 (DSM-5) (PCL-5):
timeFrame: Baseline to 6-Month Follow-Up
measure: Depressive Symptom Index-Suicidality Subscale (DSI-SS)
timeFrame: Baseline to 6-Month Follow-Up
measure: Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
timeFrame: Baseline to 6-Month Follow-Up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References: