Families Left Behind

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое RIVER
  RIVER is a peer grief support process intervention developed by Peer Support Community Partners.
• Поведенческое Enhanced care as usual
  The enhanced care as usual condition involves a psychoeducational booklet developed by What's Your Grief, as well as a list of local grief resources.

Первичные конечные точки

• Participant Grief Symptoms [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Avoidance of Grief Reminders [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Bereavement Coping Strategies [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Acceptance of the Loss [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Perceived Connectedness [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]

Вторичные конечные точки (4)

• Participant Substance Use [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Depression Severity [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Posttraumatic Stress Symptoms [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]
• Participant Physical Pain Severity [Срок оценки: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

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

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 4 центра

• Jefferson County Coroner/Medical Examiner's Office — Birmingham
• San Diego County Medical Examiner Office — San Diego
• Connecticut Office of the Chief Medical Examiner — Farmington
• Peer Support Community Partners — Watertown

Публикации

• Osilla KC, Watkins KE, Lord T, Lord G, Cook F, Nameth K, Kim JP, Hawkins W, Athey A. Study protocol for a randomized trial examining a peer grief support approach for people grieving drug overdose deaths. Addict Sci Clin Pract. 2026 Feb 11;21(1):24. doi: 10.1186/s13722-026-00652-8. PMID 41668117
• Osilla KC, Watkins KE, Lord T, Lord G, Cook F, Nameth K, Kim JP, Hawkins W, Athey A. Study protocol for a randomized trial examining a peer grief support approach for people grieving drug overdose deaths. Res Sq [Preprint]. 2025 Aug 21:rs.3.rs-6959900. doi: 10.21203/rs.3.rs-6959900/v1. PMID 40894007

Идентификаторы

NCT: NCT06854757 · 2024-N0522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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