Project Safe Guard-Trauma

NCT06876740 | Recruiting DMC

• 2 other identifiers: 24-1287HT9425-24-1-0693
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD; Firearm Injury; Suicide Prevention; Firearm Safety

Keywords

PTSD; Firearm Injury; Suicide Prevention; Firearm safety

Outcome Measures

Primary Outcomes (1)

• Firearm Storage Practices

  The primary endpoint is the improvement in actual secure firearm storage practices, as measured at the 6-month follow-up assessment, compared with baseline. The firearm storage assessment includes a grid question asking whether personally owned firearms are locked or unloaded-indicating secure storage practices. Participants can indicate that "none," "some," or "all" of their firearms are in an unloaded or locked condition. We assign a score of 2 if the secure practice applies to all firearms, 1 if it applies to some firearms, and 0 if it applies to none. A higher score corresponds to more secure storage practices. The maximum score, achieved when all firearms are both unloaded and locked, is 4, while the minimum score is 0. Improvement will be defined as a change score \> 0 between the pre-intervention and 6-month follow-up assessments.

  Baseline to 6-Month Follow-Up

Secondary Outcomes (7)

• Knowledge of Firearm Storage Practices and Suicide Risk Link

  Baseline to 6-Month Follow-Up

• Intentions to Securely Store Firearms

  Baseline to 6-Month Follow-Up

• Posttraumatic Cognitions Inventory (PTCI) negative-world subscale

  Baseline to 6-Month Follow-Up

• Client Satisfaction Questionnaire-8 (CSQ-8)

  Baseline to 6-Month Follow-Up

• Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Illness-5 (DSM-5) (PCL-5):

  Baseline to 6-Month Follow-Up

Study Arms (2)

Project Safe Guard - Trauma

EXPERIMENTAL

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).

Behavioral: Project Safe Guard - Trauma

Project Safe Guard

ACTIVE COMPARATOR

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).

Behavioral: Project Safe Guard

Interventions

Project Safe Guard - Trauma BEHAVIORAL

Project Safe Guard-Trauma (PSG-T) is a brief (15- to 20-minute), single-session lethal means safety counseling intervention (LMSC) for firearm-owning individuals with posttraumatic stress disorder (PTSD). PSG-T is designed to promote secure firearm storage practices by (1) using motivational interviewing techniques and (2) addressing the functional link between PTSD symptoms and unsafe firearm storage practices. In motivational interviewing-based LMSC, the clinician uses a guided approach to help individuals identify their values and motivations for secure firearm storage, rather than prescribing a certain set of actions. The focus is on respecting patients' autonomy and normalizing responsible firearm ownership by developing discrepancies, amplifying ambivalence, expressing empathy, rolling with resistance, and supporting self-efficacy. PSG-T combines PSG-proven motivational interviewing techniques with PTSD- and firearm-specific psychoeducation.

Project Safe Guard - Trauma

Project Safe Guard BEHAVIORAL

Project Safe Guard-Trauma (PSG) is a brief (15- to 20-minute), single-session lethal means safety counseling intervention (LMSC) for firearm-owning individuals. PSG-T is designed to promote secure firearm storage practices by using motivational interviewing techniques. In motivational interviewing-based LMSC, the clinician uses a guided approach to help individuals identify their values and motivations for secure firearm storage, rather than prescribing a certain set of actions. The focus is on respecting patients' autonomy and normalizing responsible firearm ownership by developing discrepancies, amplifying ambivalence, expressing empathy, rolling with resistance, and supporting self-efficacy.

Project Safe Guard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Links

• University of Colorado Anschutz Medical Campus Department of Emergency Medicine Funded Research

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Suicide Prevention

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Ian Stanley, PhD

CONTACT

720-848-6777; ian.stanley@cuanschutz.edu

Julia Finn, MPH

CONTACT

(303) 653-6000; emed_stanleylab@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): September 14, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)