Project Safe Guard-Trauma (PSG-T): A Randomized Controlled Trial of Counseling to Promote a Secure Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Firearm Storage Practices
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Firearm Storage Practices
时间窗: Baseline to 6-Month Follow-Up
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.
次要结局
- 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)
- Depressive Symptom Index-Suicidality Subscale (DSI-SS)(Baseline to 6-Month Follow-Up)
- Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)(Baseline to 6-Month Follow-Up)