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Набор скоро начнётся NCT07033884

Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling

Фаза I / Фаза II С лечением Suicide Secure Firearm Storage

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer Engagement and Exploration of Responsibility and Safety, Active Control.
Кому может быть актуально
Состояния в реестре: Suicide, Secure Firearm Storage. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

Suicide prevention is a top priority for the Department of Veterans Affairs (VA), with a major emphasis on developing innovative and effective ways to prevent firearm suicide. Research suggests that secure firearm storage can decrease risk for suicide and the current project aims to evaluate a novel approach to increasing secure storage through an experimental design. The intervention takes one-hour or less and involves a peer-to-peer discussion about secure firearm storage, focusing on participants' reasons for and against using more secure firearm storage practices. The project will evaluate whether Veterans who receive this intervention report greater use of secure firearm storage practices than Veterans who receive only psychoeducational materials on this topic. Secure firearm storage practices will be evaluated over the course of one year. It is hypothesized that Veterans who engage in the peer-to-peer intervention will report greater use of secure firearm storage practices than those who receive only psychoeducational materials. Relevant to Veterans' health, secure firearm storage decreases Veteran firearm suicide risk and may help prevent suicide. In addition, this peer-delivered intervention is preferred by Veterans, and has the flexibility to be implemented before suicide risk develops and in settings outside of the VA. This means the intervention has the potential to reach more Veterans, even those who do not receive VA healthcare.

Подробное описание

Veterans die by suicide at a rate 1.72 times greater than civilian counterparts. Notably, 72% of Veteran suicides result from a firearm, making firearm suicide prevention a leading priority for the Department of Veterans Affairs (VA). Secure firearm storage (e.g., unloaded, locked) mitigates risk of firearm suicide, but these practices are uncommon among firearm owning Veterans. Lethal means counseling (LMC), an intervention that promotes reduced access to potentially lethal suicide methods (e.g., firearms) through one-on-one interactions, is a promising approach to promoting secure firearm storage among Veterans. However, there are limitations to the reach and acceptability of LMC among firearm owning Veterans within VA, including healthcare providers' limited time during appointments and firearm owners' stated preference to discuss firearms with those perceived to be credible, such as fellow Veterans. As a result, most Veteran firearm owners, including those with recent suicidal ideation, report that they have not discussed firearm access with their healthcare providers. It is crucial to expand LMC efforts to non-clinician messengers to reach more Veterans. What remains unknown is how effective preferred messengers are in changing firearm storage behaviors, as well as what mechanisms impact or account for subsequent changes in firearm storage behaviors. Thus, there is a critical need to evaluate the effectiveness of peer-delivered LMC among Veteran firearm owners. Without such knowledge, preventing suicide within this population will likely remain difficult.

The overall objective of the current study is to estimate the effectiveness, as well as factors that impact or account for the effectiveness, of peer-delivered LMC. My central hypothesis is that peer-delivered LMC will lead to greater use of secure firearm storage and this will be accounted for and influenced by mechanisms conceptualized by the Theory of Planned Behavior (TPB), those proposed to be relevant in prior research, and unique mechanisms that have yet to be identified. This hypothesis was formulated on the basis of preliminary data generated through a Clinical Sciences Research and Development Career Development Award-1. During that study, I adapted a healthcare provider-delivered LMC intervention, found to increase secure firearm storage among National Guard members, for peer-delivery through an expert panel. The resulting intervention, Peer Engagement and Exploration of Responsibility and Safety (PEERS), is a 15-60 minute one-on-one LMC session centered around Motivational Interviewing principles and delivered by Veterans. In a single arm pilot trial, PEERS was feasible and acceptable among Veteran firearm owners. Thus, the rationale for this project is to determine the effectiveness, as well as mechanisms that impact or account for the effectiveness, of PEERS, providing new opportunities for suicide prevention among Veteran firearm owners. Two specific aims are proposed:

1. Estimate the superiority of PEERS compared to a psychoeducation control condition on secure firearm storage in a randomized controlled trial (N = 100; 1:1). My working hypothesis is Veterans receiving PEERS will demonstrate greater use of secure firearm storage than Veterans in the psychoeducation condition. 2. Identify indirect (2a \& 2c) and moderating (2b \& 2c) effects of the relationship between PEERS and secure firearm storage. My working hypothesis, based on the TPB, is that changes in secure firearm storage will be indirect through attitudes towards secure firearm storage, subjective norms about secure firearm storage, perceived ease of changing firearm storage, and intentions to change firearm storage (2a). I further hypothesize, based on prior research, that primary motivation for ownership (personal/family protection), Posttraumatic Stress Disorder hyperarousal symptoms, and low belief in the relationship between firearms and suicide risk, will attenuate changes in secure firearm storage (2b). To identify other factors that may influence the relationship between PEERS and secure firearm storage, I will recruit up to 24 Veterans who participated in PEERS for individual qualitative interviews regarding barriers and facilitators to engagement in the intervention (2c).

Вмешательства

  • Поведенческое Peer Engagement and Exploration of Responsibility and Safety
    PEERS involves a one-on-one session with a firearm-owning Veteran peer interventionist. The appointment will last between 15 minutes and one hour, and the modality (i.e., in-person or virtual) will be based on Veteran participant preference. Principal components of the PEERS session will include: 1) engaging - initiating conversation in a non-confrontational manner; 2) focusing - quickly concentrating the discussion on the topic of firearms and means safety; 3) evoking - reflecting the participa
  • Другое Active Control
    Veterans will receive no treatment and will not interact with peers. A no treatment control condition was selected due to the preventative nature of PEERS, as well as the early stage of evaluation for this intervention. However, given the varied recruitment outlets and subsequent lack of standardized "usual care," as well as ethical concerns with not providing important resources to firearm owning Veterans, two informational handouts will be added to this control condition. Specifically, Veteran

Первичные конечные точки

  • Modified MIRECC Lethal Means Questionnaire [Срок оценки: Eligibility Screening, Baseline, Follow-ups (1-week, 6-months, 1-year)]
  • Theory of Planned Behavior [Срок оценки: Baseline and Follow-ups (1-week, 6-months, 1-year)]
  • Beliefs and Attitudes about Firearms and Suicide [Срок оценки: Baseline and Follow-ups (1-week, 6-months, 1-year)]
  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline and Follow-ups (1-week, 6-months, 1-year)]
Вторичные конечные точки (1)
  • Semi-Structured Interview [Срок оценки: Post 1-year Follow-up]

Критерии участия

Критерии включения

  • Veteran
  • Owns at least one personal firearm
  • Displays some level of unsecure firearm storage (i.e., scores < 6 on MIRECC Lethal Means Questionnaire eligibility screener)
  • Capable of meeting via virtual modalities for appointments (i.e., owns a device capable of connecting for virtual appointments, has internet access)

Критерии исключения

  • Active psychosis
  • Insufficient English language skills
  • No reliable access to a telephone and/or device for attending appointments via virtual modalities
  • Prior participation in the PI's CDA-1 study (N = 16)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Southeast Louisiana Veterans Health Care System, New Orleans, LA — New Orleans

Идентификаторы

NCT: NCT07033884 · MHBC-003-24F · 1IK2CX002877-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗