Project Safe Guard-Trauma

Официальное название

Project Safe Guard-Trauma (PSG-T): A Randomized Controlled Trial of Counseling to Promote a Secure Home Environment

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Project Safe Guard - Trauma
  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 hel
• Поведенческое Project Safe Guard
  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

Первичные конечные точки

• Firearm Storage Practices [Срок оценки: Baseline to 6-Month Follow-Up]

Вторичные конечные точки (7)

• Knowledge of Firearm Storage Practices and Suicide Risk Link [Срок оценки: Baseline to 6-Month Follow-Up]
• Intentions to Securely Store Firearms [Срок оценки: Baseline to 6-Month Follow-Up]
• Posttraumatic Cognitions Inventory (PTCI) negative-world subscale [Срок оценки: Baseline to 6-Month Follow-Up]
• Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: Baseline to 6-Month Follow-Up]
• Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Illness-5 (DSM-5) (PCL-5): [Срок оценки: Baseline to 6-Month Follow-Up]
• Depressive Symptom Index-Suicidality Subscale (DSI-SS) [Срок оценки: Baseline to 6-Month Follow-Up]
• Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) [Срок оценки: Baseline to 6-Month Follow-Up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT06876740 · 24-1287 · HT9425-24-1-0693

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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