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临床试验/NCT06854757
NCT06854757招募中不适用

Families Left Behind: Addressing Prolonged Grief and Substance Use Disorders Among People Bereaved by Drug Overdose Deaths

RAND8 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2025年6月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
RAND
入组人数
340
试验地点
8
主要终点
Participant Grief Symptoms

研究概览

简要总结

The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • people who lost a loved one to an unintentional drug overdose death within the past year
  • age 18 and older
  • fluently understand English or Spanish
  • have the capacity to give consent (e.g., excluding those with severe cognitive impairment, those in active psychosis, and those with developmental disabilities).

排除标准

  • people who need hospitalization for psychiatric symptoms or substance use disorders. (Note, people who use drugs but who do not require hospitalization will be included.)
  • people have active suicidal ideation
  • people who lost someone to a drug overdose death more than one year ago
  • people who lost someone to a drug overdose death that was suicidal in nature or of undetermined intent

结局指标

主要结局

Participant Grief Symptoms

时间窗: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Brief Grief Questionnaire; evaluates the presence of prolonged grief

Participant Avoidance of Grief Reminders

时间窗: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Grief-Related Avoidance Questionnaire (GRAQ); evaluating the presence and extent of avoidance behaviors due to feelings of grief

Participant Bereavement Coping Strategies

时间窗: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Coping Assessment for Bereavement (CABLE); evaluating what coping strategies are being utilized and at what frequency

Participant Acceptance of the Loss

时间窗: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Typical Beliefs Questionnaire (TBQ); evaluating the presence of maladaptive cognitions related to complicated grief

Participant Perceived Connectedness

时间窗: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Continuing Bonds Scale; assessing the extent to which the participant feels bonded to the descendent

次要结局

  • Participant Substance Use(Baseline, 3-month follow up, 6-month follow up, and 12-month follow up)
  • Participant Depression Severity(Baseline, 3-month follow up, 6-month follow up, and 12-month follow up)
  • Participant Posttraumatic Stress Symptoms(Baseline, 3-month follow up, 6-month follow up, and 12-month follow up)
  • Participant Physical Pain Severity(Baseline, 3-month follow up, 6-month follow up, and 12-month follow up)

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alison Athey

Behavioral Scientist

RAND

研究点 (8)

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