Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
Study NCT ID:
NCT06560866
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-07-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Disrupting SDOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-02', 'size': 395700, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-10T17:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a single group intensive longitudinal observational study. This is not a randomized trial. All participants will receive Just Care for Families treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Determinants of Health', 'timeFrame': 'Baseline, 9 months and 18 months', 'description': 'PhenX toolkit collection including: access to health services, annual family income, current employment status, educational attainment, language proficiency, and food insecurity.'}, {'measure': 'Urine Drug Screens', 'timeFrame': 'Baseline, 9 months and 18 months', 'description': '12-panel instant urine toxicology screens and fentanyl strip screens.'}, {'measure': 'Brief Symptom Inventory (BSI)', 'timeFrame': 'Baseline, 9 months and 18 months post-baseline', 'description': '53-item self-report measure of mental health symptoms in the last 7 days, rated from 1 (not at all) to 5 (Extremely) where 5 indicates greater severity.'}, {'measure': 'Trauma Symptom Checklist (TSC)', 'timeFrame': 'Baseline, 9-months, 18-months', 'description': 'Self-report questionnaire of responses to stressful events on a scale from 0 (never) to 3 (Often) where higher scores indicates greater severity.'}, {'measure': 'Patient Health Questionnaire (PHQ)', 'timeFrame': 'Baseline, 9-months, 18-months', 'description': 'Self-report measure of depression and suicide behaviors from 0 (Not At All) to 3 (Nearly Every Day). Higher scores indicate greater symptom severity.'}, {'measure': 'Demographics', 'timeFrame': 'Baseline, 9-months, 18-months', 'description': 'Demographic questionnaire including: race, ethnicity, gender identity, sex, and family constellation. Consistent with the PhenX toolkit protocol.'}, {'measure': 'Parent Digital Check-In', 'timeFrame': 'Baseline through 18 months post-Baseline', 'description': 'Weekly self report of SDOH factors (e.g., employment, housing, food security, etc.).'}, {'measure': 'Clinician Weekly Report', 'timeFrame': 'through treatment completion, an average of 9 months.', 'description': 'Clinician report of SDOH factors targeted during treatment.'}, {'measure': 'ODHS Administrative Data - case closure', 'timeFrame': 'Data will be collected for each participant at the end of their participation and include 24 months of data per participant.', 'description': 'Data related to parent involvement in the ODHS system including date of case closure.'}, {'measure': 'ODHS Administrative Data - new referras', 'timeFrame': 'Data will be collected for each participant at the end of their participation and include 24 months of data per participant.', 'description': 'Data related to parent involvement in the ODHS system including new hotline reports.'}, {'measure': 'County Social Determinants of Health', 'timeFrame': 'Study Year 2 through Study Year 5; approximately 3 years', 'description': 'Publicly available data from participating counties on presence of structural SDOH (no scale)'}, {'measure': 'Just Care for Families Program Delivery Coding', 'timeFrame': 'Study Year 2 through Study Year 5; approximately 3 years.', 'description': 'Expert coding of group supervision sessions (no scale). More (higher) observed skills is an indication of better program delivery.'}, {'measure': 'Clinician Identified Participant SDOH needs', 'timeFrame': 'Study Year 2 through Study Year 5.', 'description': 'Clinicians will report weekly in case documentation participant SDOH needs.'}, {'measure': 'Life Events Checklist (LEC)', 'timeFrame': 'Baseline, 9-months, 18-months', 'description': 'Self-report measure of lifetime exposure to potentially traumatic experiences. Consistent with the PhenX toolkit protocol.'}, {'measure': 'Oregon Health Plan/Medicaid behavioral health encounter data', 'timeFrame': 'Data will be collected for each participant at the end of their participation and include 24 months of data per participant.', 'description': 'Administrative data collected to measure long-term prevention outcomes including: l behavioral health encounters related to Opioid/Methamphetamine misuse disorders.'}, {'measure': 'Oregon Health Plan/Medicaid medical encounter data', 'timeFrame': 'Data will be collected for each participant at the end of their participation and include 24 months of data per participant.', 'description': 'Administrative data collected to measure long-term prevention outcomes including: medical encounters related to Opioid/Methamphetamine misuse disorders.'}, {'measure': 'Service delivery and treatment costs', 'timeFrame': 'through treatment completion, an average of 9 months.', 'description': 'Costs (direct and indirect) associated with delivery of treatment for each patient.'}, {'measure': 'Health Literacy', 'timeFrame': 'Baseline, 9-months, 18-months', 'description': 'Assessment of the ability to read and understand common medical terms. Consistent with the PhenX toolkit protocol. Scored from 0-18, with higher scores better. Scores between 0-14 indicate low health literacy.'}, {'measure': 'Major Experiences of Everyday Discrimination', 'timeFrame': 'Baseline, 9-months, 18-months', 'description': 'Self-report measure of discrimination experiences and frequency. 10 items where higher is better (less SDOH issues)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Determinants of Health', 'Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effectiveness of the Just Care for Families program in preventing Oregon Department of Human Services (ODHS)-involved parents in rural communities from escalating opioid and/or methamphetamine use and mental health disorders by disrupting the associated social determinants of health (SDOH). In addition, investigators will examine the impacts of SDOH on Just Care treatment and the associated costs from the perspective of provider clinics delivering Just Care. Just Care is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. Just Care involves treatment components, supported by ongoing purposeful engagement: (1) Substance use treatment; (2) Mental health treatment; (3) Parent management training; (4) Community building; (5) Systems Navigation; and (6) Addressing basic needs.', 'detailedDescription': "This study provides multiple tests of the mechanisms by which Just Care for Families disrupts the effects of lifetime social determinants of health (SDOH) on ultimate outcomes of preventing escalation of opioid and/or methamphetamine use and suicide (ideation, intention, attempts). Just Care for Families 's effect on these outcomes is hypothesized to occur through two mechanisms of action: (1) improvement in malleable SDOH (direct targets of intervention) and (2) improvement in substance use and mental health problems (intermediate prevention outcomes). Analyses will examine whether the effects vary as a function of non-malleable external, structural SDOH, such as community poverty and healthcare service availability. Additionally, system dynamics will be used to examine patterns of influence between SDOH and Just Care for Families intervention targets, case outcomes, and associated costs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParents:\n\n* Use or misuse of opioids in the last year, and/or any methamphetamine use in the last year\n* Parent of a child, age 0-18\n* Current mental health symptoms\n* Resident of participating county (Lane, Linn, Benton, Douglas, Lincoln)\n* Insured by Oregon Health Plan (Medicaid)\n* Access to a computer or smartphone; or wireless/cellular connection if a device were to be provided; or reliable access to a landline to receive a brief weekly phone assessment in place of the digital assessment\n\nClinical Staff:\n\n* clinician at a participating clinic\n* Providing Just Care for Families services to parents in the study at any point during study\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT06560866', 'briefTitle': 'Disrupting SDOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions', 'organization': {'class': 'OTHER', 'fullName': 'Chestnut Health Systems'}, 'officialTitle': 'Disrupting Social Determinants of Health to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions', 'orgStudyIdInfo': {'id': '1172-0623'}, 'secondaryIdInfos': [{'id': 'R01DA057556', 'link': 'https://reporter.nih.gov/quickSearch/R01DA057556', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Just Care for Families', 'description': 'Parents receiving Just Care for Families', 'interventionNames': ['Behavioral: Just Care for Families']}], 'interventions': [{'name': 'Just Care for Families', 'type': 'BEHAVIORAL', 'description': 'Just Care for Families is a behavioral intervention to address the needs of families involved in or at-risk for involvement with the child welfare system. Just Care involves treatment components, supported by ongoing purposeful engagement: (1) Substance use treatment including contingency management and positive reinforcement, day planning, healthy environments and peer choices, and refusal skills; (2) Mental health treatment including cognitive behavioral therapy, developing healthy coping skills, emotion regulation skills, exposure therapy, and referral for medication management; (3) Parent management training including parenting skills, nurturing and attachment, reinforcement, emotion regulation, supervision, structure, non-harsh discipline, and nutrition; (4) Community building including indigenous and external social supports; (5) Systems navigation; and (6) provision of assistance with basic needs including assistance with housing and employment.', 'armGroupLabels': ['Just Care for Families']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Baker', 'role': 'CONTACT', 'email': 'mkbaker@chestnut.org', 'phone': '309-451-7855'}, {'name': 'Lisa Saldana, PhD', 'role': 'CONTACT', 'email': 'lsaldana@chestnut.org', 'phone': '541-915-6614'}, {'name': 'Lisa Saldana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chestnut Health Systems', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'centralContacts': [{'name': 'Lisa Saldana, PhD', 'role': 'CONTACT', 'email': 'lsaldana@chestnut.org', 'phone': '541-915-6614'}, {'name': 'Ryan Singh, PhD', 'role': 'CONTACT', 'email': 'rrsingh@chestnut.org', 'phone': '541-844-8532'}], 'overallOfficials': [{'name': 'Lisa Saldana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chestnut Health Systems'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chestnut Health Systems', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Lisa Saldana', 'investigatorAffiliation': 'Chestnut Health Systems'}}}}