Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-26 @ 9:11 PM
Study NCT ID:
NCT06854757
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Families Left Behind
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090382', 'term': 'Prolonged Grief Disorder'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045483', 'term': 'Rivers'}], 'ancestors': [{'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D005618', 'term': 'Fresh Water'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Grief Symptoms', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Brief Grief Questionnaire; evaluates the presence of prolonged grief'}, {'measure': 'Participant Avoidance of Grief Reminders', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Grief-Related Avoidance Questionnaire (GRAQ); evaluating the presence and extent of avoidance behaviors due to feelings of grief'}, {'measure': 'Participant Bereavement Coping Strategies', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Coping Assessment for Bereavement (CABLE); evaluating what coping strategies are being utilized and at what frequency'}, {'measure': 'Participant Acceptance of the Loss', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Typical Beliefs Questionnaire (TBQ); evaluating the presence of maladaptive cognitions related to complicated grief'}, {'measure': 'Participant Perceived Connectedness', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Continuing Bonds Scale; assessing the extent to which the participant feels bonded to the descendent'}], 'secondaryOutcomes': [{'measure': 'Participant Substance Use', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Tobacco, Alcohol, Prescription Medications, and Other Substances Tool (TAPS); assessing the presence and frequency of past 30-day substance use'}, {'measure': 'Participant Depression Severity', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Beck Depression Inventory (BDI); evaluating the presence and severity of depressive symptoms'}, {'measure': 'Participant Posttraumatic Stress Symptoms', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'Posttraumatic Stress Disorder Checklist (PCL-5); evaluating the severity of symptoms associated with posttraumatic stress disorder'}, {'measure': 'Participant Physical Pain Severity', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow up, and 12-month follow up', 'description': 'PEG; evaluating the intensity and interference of physical pain on daily life and well-being'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overdose', 'grief', 'bereavement', 'prolonged grief disorder'], 'conditions': ['Grief', 'Grief Disorder, Prolonged', 'Overdose Accidental', 'Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '40894007', 'type': 'DERIVED', 'citation': '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. Res Sq [Preprint]. 2025 Aug 21:rs.3.rs-6959900. doi: 10.21203/rs.3.rs-6959900/v1.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people who lost a loved one to an unintentional drug overdose death within the past year\n* age 18 and older\n* fluently understand English or Spanish\n* have the capacity to give consent (e.g., excluding those with severe cognitive impairment, those in active psychosis, and those with developmental disabilities).\n\nExclusion Criteria:\n\n* 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.)\n* people have active suicidal ideation\n* people who lost someone to a drug overdose death more than one year ago\n* people who lost someone to a drug overdose death that was suicidal in nature or of undetermined intent'}, 'identificationModule': {'nctId': 'NCT06854757', 'briefTitle': 'Families Left Behind', 'organization': {'class': 'OTHER', 'fullName': 'RAND'}, 'officialTitle': 'Families Left Behind: Addressing Prolonged Grief and Substance Use Disorders Among People Bereaved by Drug Overdose Deaths', 'orgStudyIdInfo': {'id': '2024-N0522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer grief support + enhanced care as usual', 'description': '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).', 'interventionNames': ['Behavioral: RIVER', 'Behavioral: Enhanced care as usual']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced care as usual', 'description': 'Participants will receive a psychoeducational booklet and a list of local grief support resources.', 'interventionNames': ['Behavioral: Enhanced care as usual']}], 'interventions': [{'name': 'RIVER', 'type': 'BEHAVIORAL', 'description': 'RIVER is a peer grief support process intervention developed by Peer Support Community Partners.', 'armGroupLabels': ['Peer grief support + enhanced care as usual']}, {'name': 'Enhanced care as usual', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Enhanced care as usual', 'Peer grief support + enhanced care as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35203', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Dye, MD', 'role': 'CONTACT', 'email': 'dwdye@uab.edu'}], 'facility': "Jefferson County Coroner/Medical Examiner's Office", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Lucas, MD', 'role': 'CONTACT', 'email': 'jonathan.lucas@sdcounty.ca.gov'}], 'facility': 'San Diego County Medical Examiner Office', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06032', 'city': 'Farmington', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Gill, MD', 'role': 'CONTACT', 'email': 'jgill@ocme.org'}], 'facility': 'Connecticut Office of the Chief Medical Examiner', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Peer Support Community Partners', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}], 'centralContacts': [{'name': 'Alison Athey, PhD', 'role': 'CONTACT', 'email': 'aathey@rand.org', 'phone': '(703) 413-1100', 'phoneExt': '5680'}, {'name': 'Karen Osilla, PhD', 'role': 'CONTACT', 'email': 'kosilla@stanford.edu'}], 'overallOfficials': [{'name': 'Alison Athey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAND'}, {'name': 'Karen Osilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data will be shared by following NIH HEAL Data Sharing Policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAND', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Peer Support Community Partners', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Behavioral Scientist', 'investigatorFullName': 'Alison Athey', 'investigatorAffiliation': 'RAND'}}}}