Skip to content

Families Left Behind

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06854757
Enrollment
340
Registered
2025-03-03
Start date
2025-06-13
Completion date
2030-10-31
Last updated
2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grief, Grief Disorder, Prolonged, Overdose Accidental, Substance Use Disorders

Keywords

overdose, grief, bereavement, prolonged grief disorder

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.

Interventions

BEHAVIORALRIVER

RIVER is a peer grief support process intervention developed by Peer Support Community Partners.

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.

Sponsors

Stanford University
CollaboratorOTHER
Peer Support Community Partners
CollaboratorUNKNOWN
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant Perceived ConnectednessBaseline, 3-month follow up, 6-month follow up, and 12-month follow upContinuing Bonds Scale; assessing the extent to which the participant feels bonded to the descendent
Participant Avoidance of Grief RemindersBaseline, 3-month follow up, 6-month follow up, and 12-month follow upGrief-Related Avoidance Questionnaire (GRAQ); evaluating the presence and extent of avoidance behaviors due to feelings of grief
Participant Grief SymptomsBaseline, 3-month follow up, 6-month follow up, and 12-month follow upBrief Grief Questionnaire; evaluates the presence of prolonged grief
Participant Bereavement Coping StrategiesBaseline, 3-month follow up, 6-month follow up, and 12-month follow upCoping Assessment for Bereavement (CABLE); evaluating what coping strategies are being utilized and at what frequency
Participant Acceptance of the LossBaseline, 3-month follow up, 6-month follow up, and 12-month follow upTypical Beliefs Questionnaire (TBQ); evaluating the presence of maladaptive cognitions related to complicated grief

Secondary

MeasureTime frameDescription
Participant Depression SeverityBaseline, 3-month follow up, 6-month follow up, and 12-month follow upBeck Depression Inventory (BDI); evaluating the presence and severity of depressive symptoms
Participant Posttraumatic Stress SymptomsBaseline, 3-month follow up, 6-month follow up, and 12-month follow upPosttraumatic Stress Disorder Checklist (PCL-5); evaluating the severity of symptoms associated with posttraumatic stress disorder
Participant Physical Pain SeverityBaseline, 3-month follow up, 6-month follow up, and 12-month follow upPEG; evaluating the intensity and interference of physical pain on daily life and well-being
Participant Substance UseBaseline, 3-month follow up, 6-month follow up, and 12-month follow upTobacco, Alcohol, Prescription Medications, and Other Substances Tool (TAPS); assessing the presence and frequency of past 30-day substance use

Countries

United States

Contacts

Primary ContactAlison Athey, PhD
aathey@rand.org(703) 413-1100
Backup ContactKaren Osilla, PhD
kosilla@stanford.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026