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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-24-1-0693 | Other Grant/Funding Number | United States Department of Defense |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ian Stanley, PhD | Contact | 720-848-6777 | ian.stanley@cuanschutz.edu | |
| Julia Finn, MPH | Contact | (303) 653-6000 | emed_stanleylab@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| University of Colorado Anschutz Medical Campus Department of Emergency Medicine Funded Research | View source |
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This trial involves sensitive participant information, including information regarding suicidality, mental health, and firearm ownership and requires careful handling to prevent any negative impact on participants or their families.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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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.
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| 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. |
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| Baseline to 6-Month Follow-Up |
| 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). | Baseline to 6-Month Follow-Up |
| 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 | Baseline to 6-Month Follow-Up |
| 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. | Baseline to 6-Month Follow-Up |
| Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Illness-5 (DSM-5) (PCL-5): | PTSD symptoms will be evaluated using the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure. Participants rate the severity of each symptom over the past month on a 5-point scale (0 =Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). A composite score is generated from responses with symptom cluster scores corresponding to DSM-5 diagnostic criteria (i.e., intrusions, avoidance, negative alterations in cognitions and mood, hyperarousal); higher scores reflect more severe PTSD symptomatology. | Baseline to 6-Month Follow-Up |
| Depressive Symptom Index-Suicidality Subscale (DSI-SS) | Suicidal ideation severity over the past 2 weeks will be evaluated using the Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure. Respondents rate each item on a 4-point scale ranging from 0 to 3 (e.g., Item 1: 0 = I do not have thoughts of killing myself; 1 = Sometimes I have thoughts of killing myself; 2 = Most of the time I have thoughts of killing myself; 3 = I always have thoughts of killing myself). A total score ranging from 0 to 12 is calculated from summed responses, with higher scores indicating more severe suicidal ideation. | Baseline to 6-Month Follow-Up |
| Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) | The self-report SITBI-R assesses various aspects of self-injurious thoughts and behaviors. The evaluation measures will only include the questions about the lifetime occurrence of the target construct (e.g., the suicidal ideation module asks respondents, "Have you ever had thoughts of killing yourself?"). | Baseline to 6-Month Follow-Up |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |