GriefNCT06854757
Families Left Behind
A study testing RIVER and Enhanced care as usual in people with Grief and Grief Disorder, Prolonged, run by RAND at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grief, Grief Disorder, Prolonged, Overdose Accidental
- What is being tested?
- RIVER and Enhanced care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Jun 2025to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karen Osilla, PhD contact
United States4 sites, 3 recruiting
- Recruiting
Jefferson County Coroner/Medical Examiner's Office
Birmingham, Alabama, 35203
Daniel Dye, MD, dwdye@uab.edu
- Recruiting
Connecticut Office of the Chief Medical Examiner
Farmington, Connecticut, 06032
James Gill, MD, jgill@ocme.org
- Recruiting
San Diego County Medical Examiner Office
San Diego, California, 92123
Jonathan Lucas, MD, jonathan.lucas@sdcounty.ca.gov
- Active, not recruiting
Peer Support Community Partners
Watertown, Massachusetts, 02472
About this study
Official title: Families Left Behind: Addressing Prolonged Grief and Substance Use Disorders Among People Bereaved by Drug Overdose Deaths
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.
- Being tested
- RIVER, Enhanced care as usual
- Keywords
- overdose, grief, bereavement, prolonged grief disorder
- Medical subject headings
- Prolonged Grief Disorder, Substance-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIVERBehavioural
RIVER is a peer grief support process intervention developed by Peer Support Community Partners.
Enhanced care as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: RIVER; Behavioral: Enhanced care as usual |
| Enhanced care as usual | Active comparator | Participants will receive a psychoeducational booklet and a list of local grief support resources. Receives: Behavioral: Enhanced care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Grief Symptoms
Brief Grief Questionnaire; evaluates the presence of prolonged grief
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Avoidance of Grief Reminders
Grief-Related Avoidance Questionnaire (GRAQ); evaluating the presence and extent of avoidance behaviors due to feelings of grief
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Bereavement Coping Strategies
Coping Assessment for Bereavement (CABLE); evaluating what coping strategies are being utilized and at what frequency
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Acceptance of the Loss
Typical Beliefs Questionnaire (TBQ); evaluating the presence of maladaptive cognitions related to complicated grief
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Perceived Connectedness
Continuing Bonds Scale; assessing the extent to which the participant feels bonded to the descendent
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Secondary outcomes (4)
Participant Substance Use
Tobacco, Alcohol, Prescription Medications, and Other Substances Tool (TAPS); assessing the presence and frequency of past 30-day substance use
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Depression Severity
Beck Depression Inventory (BDI); evaluating the presence and severity of depressive symptoms
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Posttraumatic Stress Symptoms
Posttraumatic Stress Disorder Checklist (PCL-5); evaluating the severity of symptoms associated with posttraumatic stress disorder
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Physical Pain Severity
PEG; evaluating the intensity and interference of physical pain on daily life and well-being
Measured: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start13 Jun 2025
- Primary completion29 Aug 2026 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GriefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a randomized controlled trial (RCT) of peer grief support plus enhanced care as usual vs. enhanced care as usual only (i.e., parallel interventional study model).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Peer Support Community Partners
- Responsible party
- Principal investigator, Alison Athey, RAND
- Investigators
- Alison Athey, PhD, Principal investigator, RANDKaren Osilla, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854757
- Sponsor's protocol ID
- 2024-N0522
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared by following NIH HEAL Data Sharing Policies.
Publications
Osilla KC, Watkins KE, Lord T, Lord G, Cook F, Nameth K, Kim JP, Hawkins W, Athey A. Study protocol for a randomized trial examining a peer grief support approach for people grieving drug overdose deaths. Addict Sci Clin Pract. 2026 Feb 11;21(1):24. doi: 10.1186/s13722-026-00652-8.
PubMed 41668117Osilla KC, Watkins KE, Lord T, Lord G, Cook F, Nameth K, Kim JP, Hawkins W, Athey A. Study protocol for a randomized trial examining a peer grief support approach for people grieving drug overdose deaths. Res Sq [Preprint]. 2025 Aug 21:rs.3.rs-6959900. doi: 10.21203/rs.3.rs-6959900/v1.
PubMed 40894007
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Left Behind: Addressing Prolonged Grief and Substance Use Disorders Among People Bereaved by Drug Overdose Deaths
- ClinicalTrials.gov ID
- NCT06854757
- Acronym / sponsor ID
- 2024-N0522
- Keywords
- overdose, grief, bereavement, prolonged grief disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Stanford University, Peer Support Community Partners
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct a randomized controlled trial (RCT) of peer grief support plus enhanced care as usual vs. enhanced care as usual only (i.e., parallel interventional study model).
| Arm | Type | Receives |
|---|---|---|
| Peer grief support + enhanced care as usual | Experimental | Behavioral: RIVER, Behavioral: Enhanced care as usualParticipants 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). |
| Enhanced care as usual | Active comparator | Behavioral: Enhanced care as usualParticipants will receive a psychoeducational booklet and a list of local grief support resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIVERRIVER is a peer grief support process intervention developed by Peer Support Community Partners. | Behavioural | Peer grief support + enhanced care as usual |
| Enhanced care as usualThe enhanced care as usual condition involves a psychoeducational booklet developed by What's Your Grief, as well as a list of local grief resources. | Behavioural | Enhanced care as usual, Peer grief support + enhanced care as usual |
Primary outcome
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
4 secondary outcomes
Participant Substance Use
Time frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Depression Severity
Time frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Posttraumatic Stress Symptoms
Time frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Participant Physical Pain Severity
Time frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 41668117Osilla KC, Watkins KE, Lord T, Lord G, Cook F, Nameth K, Kim JP, Hawkins W, Athey A. Study protocol for a randomized trial examining a peer grief support approach for people grieving drug overdose deaths. Addict Sci Clin Pract. 2026 Feb 11;21(1):24. doi: 10.1186/s13722-026-00652-8.
- Derived from this study: PubMed 40894007Osilla KC, Watkins KE, Lord T, Lord G, Cook F, Nameth K, Kim JP, Hawkins W, Athey A. Study protocol for a randomized trial examining a peer grief support approach for people grieving drug overdose deaths. Res Sq [Preprint]. 2025 Aug 21:rs.3.rs-6959900. doi: 10.21203/rs.3.rs-6959900/v1.
- Individual participant dataSharing planned: Yes. Data will be shared by following NIH HEAL Data Sharing Policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Osilla, PhD contact
Alison Athey, PhD principal investigator
RAND
Karen Osilla, PhD principal investigator
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIVER and Enhanced care as usual in people with Grief and Grief Disorder, Prolonged, run by RAND at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Athey, PhD ((703) 413-1100 ext. 5680, aathey@rand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Grief Symptoms (time frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.