Project Safe Guard-Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Project Safe Guard - Trauma
BehavioralProject 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
BehavioralProject 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.
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Project Safe Guard - TraumaExperimental treatment 1 intervention
Group B: Project Safe GuardActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to 6-Month Follow-UpSecondary outcomes
1
Knowledge of Firearm Storage Practices and Suicide Risk Link
Participants will be asked, "To what extent do you think owning a firearm is related to suicide risk?" and "To what extent do you think how a firearm is stored (e.g., unlocked, loaded) is related to suicide risk?" Responses are captured on a 5-point Likert scale (1 = Not at all, 2= Slightly, 3 = Moderately, 4 = Strongly, 5 = Extremely).
Time frame
Baseline to 6-Month Follow-Up2
Intentions to Securely Store Firearms
Participants will be asked: (a) "How likely would you be to adhere to your clinician's recommendations to store your firearm locked for safety purposes?" and (b) "How likely would you be to adhere to your clinician's recommendations to store your firearm unloaded for safety purposes?" Responses are captured on a 5-point scale (1 = Very Unlikely, 2 = Unlikely, 3 = Neutral/Possibly, 4 = Likely, 5 = Very Likely).
Time frame
Baseline to 6-Month Follow-Up3
Posttraumatic Cognitions Inventory (PTCI) negative-world subscale
Posttraumatic stress disorder-related negative cognitions about the world will be evaluated using the Posttraumatic Cognitions Inventory (PTCI). The PTCI is a 33-item self-report measure of negative cognitions about the self and world and self-blame. Respondents rate the degree to which they agree or disagree with each statement on a 7-point scale (1 = Totally disagree, 2 = Disagree very much, 3 = Disagree slightly, 4 = Neither agree nor disagree, 5 = Agree slightly, 6 = Agree very much, 7 = Totally agree). We will use the total score of the 7-item PTCI negative-world subscale to measure the purported mediator of change of Project Safe Guard-Trauma
Time frame
Baseline to 6-Month Follow-Up4
Client Satisfaction Questionnaire-8 (CSQ-8)
Participant acceptability of services will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item self-report measure. Each item evaluated using varying descriptive scales with corresponding numerical values. Scores are summed across items, with higher values indicating greater acceptability of the services received.
Time frame
Baseline to 6-Month Follow-UpSponsors and contacts
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Source ClinicalTrials.gov