Families Left Behind

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRAND

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Peer grief support + enhanced care as usualExperimental treatment 2 interventions
Group B: Enhanced care as usualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Participant Grief Symptoms

Brief Grief Questionnaire; evaluates the presence of prolonged grief

Time frame
Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
2

Participant Avoidance of Grief Reminders

Grief-Related Avoidance Questionnaire (GRAQ); evaluating the presence and extent of avoidance behaviors due to feelings of grief

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

Participant Bereavement Coping Strategies

Coping Assessment for Bereavement (CABLE); evaluating what coping strategies are being utilized and at what frequency

Time frame
Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
4

Participant Acceptance of the Loss

Typical Beliefs Questionnaire (TBQ); evaluating the presence of maladaptive cognitions related to complicated grief

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

Secondary outcomes

1

Participant Substance Use

Tobacco, Alcohol, Prescription Medications, and Other Substances Tool (TAPS); assessing the presence and frequency of past 30-day substance use

Time frame
Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
2

Participant Depression Severity

Beck Depression Inventory (BDI); evaluating the presence and severity of depressive symptoms

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

Participant Posttraumatic Stress Symptoms

Posttraumatic Stress Disorder Checklist (PCL-5); evaluating the severity of symptoms associated with posttraumatic stress disorder

Time frame
Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
4

Participant Physical Pain Severity

PEG; evaluating the intensity and interference of physical pain on daily life and well-being

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

Other outcomes

Sponsors and contacts

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RAND

Lead sponsor

Stanford University

Collaborator

Peer Support Community Partners

Collaborator