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NCT Number: NCT06854757

Families Left Behind

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIVER

Behavioral

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

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.

Primary outcomes

  1. Participant Grief Symptoms

    Time frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up

    Brief Grief Questionnaire; evaluates the presence of prolonged grief

  2. Participant Avoidance of Grief Reminders

    Time frame: 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

  3. Participant Bereavement Coping Strategies

    Time frame: 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

  4. Participant Acceptance of the Loss

    Time frame: 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

  5. Participant Perceived Connectedness

    Time frame: 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 outcomes

  1. Participant Substance Use

    Time frame: 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

  2. Participant Depression Severity

    Time frame: 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

  3. Participant Posttraumatic Stress Symptoms

    Time frame: 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

  4. Participant Physical Pain Severity

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Athey, PhD

CONTACT

[email protected]

(703) 413-1100 ext. 5680

Karen Osilla, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Peer Support Community Partners
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Mar 3, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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