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Clinical Trials/NCT06854757
NCT06854757RecruitingNot Applicable

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

RAND4 sites in 1 country340 target enrollmentStarted: June 13, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
RAND
Enrollment
340
Locations
4
Primary Endpoint
Participant Grief Symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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).

Intervention: RIVER (Behavioral)

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).

Intervention: Enhanced care as usual (Behavioral)

Enhanced care as usual

Active Comparator

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

Intervention: Enhanced care as usual (Behavioral)

Outcomes

Primary Outcomes

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

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

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

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

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

  • 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)

Investigators

Sponsor
RAND
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alison Athey

Behavioral Scientist

RAND

Study Sites (4)

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