Recruiting

RIVER Model

Sponsor:

RAND

Code:

NCT06854757

Conditions

Grief

Grief Disorder, Prolonged

Overdose Accidental

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RIVER

Enhanced care as usual

Study Details

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

Study ID

NCT06854757

Start date

Jun 13, 2025

Status verified date

Aug, 2025

Completion date

Oct, 2030

Anticipated

Primary completion date

Aug 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

active comparator: Enhanced care as usual

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

Interventions

RIVER

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Karen Osilla, PhD

kosilla@stanford.edu

Locations

Jefferson County Coroner/Medical Examiner's Office

Recruiting

Birmingham, Alabama, United States, 35203

Contacts

Daniel Dye, MD

dwdye@uab.edu

San Diego County Medical Examiner Office

Recruiting

San Diego, California, United States, 92123

Contacts

Connecticut Office of the Chief Medical Examiner

Recruiting

Farmington, Connecticut, United States, 06032

Contacts

James Gill, MD

jgill@ocme.org

More Information

Sponsor

RAND

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Keywords

  • overdose
  • grief
  • bereavement
  • prolonged grief disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RAND on 2025-08-21.