Families Left Behind

NCT06854757 | Recruiting DMC

• 1 other identifier: 2024-N0522
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

overdose; grief; bereavement; prolonged grief disorder

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (2)

Peer grief support + enhanced care as usual

EXPERIMENTAL

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; Behavioral: Enhanced care as usual

Enhanced care as usual

ACTIVE COMPARATOR

Participants will receive a psychoeducational booklet and a list of local grief support resources.

Behavioral: Enhanced care as usual

Interventions

RIVER BEHAVIORAL

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

Peer grief support + enhanced care as usual

Enhanced care as usual BEHAVIORAL

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.

Enhanced care as usual; Peer grief support + enhanced care as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• RAND: lead
• Stanford University: collaborator
• Peer Support Community Partners: collaborator

Study Sites (4)

Jefferson County Coroner/Medical Examiner's Office

Birmingham, Alabama, 35203, United States

RECRUITING

San Diego County Medical Examiner Office

San Diego, California, 92123, United States

RECRUITING

Connecticut Office of the Chief Medical Examiner

Farmington, Connecticut, 06032, United States

RECRUITING

Peer Support Community Partners

Watertown, Massachusetts, 02472, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Prolonged Grief Disorder; Substance-Related Disorders; Drug Overdose

Interventions

Rivers

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Prescription Drug Misuse; Drug Misuse

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Fresh Water; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Alison Athey, PhD

  RAND

  PRINCIPAL INVESTIGATOR

• Karen Osilla, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Athey, PhD

CONTACT

(703) 413-1100; aathey@rand.org

Karen Osilla, PhD

CONTACT

kosilla@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Behavioral Scientist

Model Details: 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).

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (4)