Clinical trial NCT06854757: Families Left Behind
Official title: Families Left Behind: Addressing Prolonged Grief and Substance Use Disorders Among People Bereaved by Drug Overdose Deaths
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Grief
Grief Disorder, Prolonged
Overdose Accidental
Substance Use Disorders
Keywords: overdose
grief
bereavement
prolonged grief disorder
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Peer Support Community Partners
First posted: 2025-03-03
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a randomized controlled trial (RCT) of peer grief support plus enhanced care as usual vs. enhanced care as usual only (i.e., parallel interventional study model).
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant Grief Symptoms
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Avoidance of Grief Reminders
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Bereavement Coping Strategies
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Acceptance of the Loss
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Perceived Connectedness
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Secondary outcomes:
measure: Participant Substance Use
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Depression Severity
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Posttraumatic Stress Symptoms
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
measure: Participant Physical Pain Severity
timeFrame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Jefferson County Coroner/Medical Examiner's Office
state: Alabama
city: San Diego
country: United States
facility: San Diego County Medical Examiner Office
state: California
city: Farmington
country: United States
facility: Connecticut Office of the Chief Medical Examiner
state: Connecticut
city: Watertown
country: United States
facility: Peer Support Community Partners
state: Massachusetts
Study officials:
affiliation: RAND
name: Alison Athey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Karen Osilla, PhD
role: PRINCIPAL_INVESTIGATOR
References: