Families Left Behind

Not Applicable

Not yet recruiting

• Conditions: Grief; Grief Disorder, Prolonged; Overdose Accidental; Substance Use Disorders

• Registration Number: NCT06854757
• Lead Sponsor: RAND

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2026-09-01
• Primary Completion: 2029-08-29
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 340

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Jefferson County Coroner/Medical Examiner's Office; 🇺🇸 Birmingham, Alabama, United States

San Diego County Medical Examiner Office; 🇺🇸 San Diego, California, United States

Connecticut Office of the Chief Medical Examiner; 🇺🇸 Farmington, Connecticut, United States

Peer Support Community Partners; 🇺🇸 Watertown, Massachusetts, United States