Families Left Behind

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders; Grief; Overdose Accidental; Grief Disorder, Prolonged
• Intervention / Treatment: Behavioral: RIVER; Behavioral: Enhanced care as usual

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Osilla, PhD; Email: kosilla@stanford.edu
• Study Contact Backup: Name: Alison Athey, PhD; Phone Number: 5680 (703) 413-1100; Email: aathey@rand.org

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Recruiting
      • Jefferson County Coroner/Medical Examiner's Office
      • Contact: Daniel Dye, MD; Email: dwdye@uab.edu
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • San Diego County Medical Examiner Office
      • Contact: Jonathan Lucas, MD; Email: jonathan.lucas@sdcounty.ca.gov
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Recruiting
      • Connecticut Office of the Chief Medical Examiner
      • Contact: James Gill, MD; Email: jgill@ocme.org
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Active, not recruiting
      • Peer Support Community Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer grief support + enhanced care as usual; Participants in this arm will be matched with a peer grief support specialist who will provide support that aligns with the RIVER process model developed by Peer Community Support Partners. They will also receive a psychoeducational booklet and a list of local grief support resources (i.e., the enhanced care as usual condition).	Behavioral: RIVER; RIVER is a peer grief support process intervention developed by Peer Support Community Partners.; Behavioral: 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.
Active Comparator: Enhanced care as usual; Participants will receive a psychoeducational booklet and a list of local grief support resources.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Grief Symptoms	Brief Grief Questionnaire; evaluates the presence of prolonged grief	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Avoidance of Grief Reminders	Grief-Related Avoidance Questionnaire (GRAQ); evaluating the presence and extent of avoidance behaviors due to feelings of grief	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Bereavement Coping Strategies	Coping Assessment for Bereavement (CABLE); evaluating what coping strategies are being utilized and at what frequency	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Acceptance of the Loss	Typical Beliefs Questionnaire (TBQ); evaluating the presence of maladaptive cognitions related to complicated grief	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Perceived Connectedness	Continuing Bonds Scale; assessing the extent to which the participant feels bonded to the descendent	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Substance Use	Tobacco, Alcohol, Prescription Medications, and Other Substances Tool (TAPS); assessing the presence and frequency of past 30-day substance use	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Depression Severity	Beck Depression Inventory (BDI); evaluating the presence and severity of depressive symptoms	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Posttraumatic Stress Symptoms	Posttraumatic Stress Disorder Checklist (PCL-5); evaluating the severity of symptoms associated with posttraumatic stress disorder	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Physical Pain Severity	PEG; evaluating the intensity and interference of physical pain on daily life and well-being	Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Stanford University; Peer Support Community Partners
• Investigators: Principal Investigator: Karen Osilla, PhD, Stanford University; Principal Investigator: Alison Athey, PhD, RAND

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: overdose; prolonged grief disorder; grief; bereavement
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Drug Misuse; Mental Disorders; Chemically-Induced Disorders; Prescription Drug Misuse; Prolonged Grief Disorder; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: 2024-N0522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared by following NIH HEAL Data Sharing Policies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No