Disrupting SDOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions
NCT Number: NCT06560866
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Determinants of Health|Substance-Related Disorders
Interventions: BEHAVIORAL: Just Care for Families
Sponsor: Chestnut Health Systems
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-24
Completion Date: 2028-01-30
Locations: Chestnut Health Systems, Eugene, Oregon, 97401, United States

Summary:
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.

Primary Outcome Measures: Social Determinants of Health, PhenX toolkit collection including: access to health services, annual family income, current employment status, educational attainment, language proficiency, and food insecurity., Baseline, 9 months and 18 months|Urine Drug Screens, 12-panel instant urine toxicology screens and fentanyl strip screens., Baseline, 9 months and 18 months|Brief Symptom Inventory (BSI), 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., Baseline, 9 months and 18 months post-baseline|Trauma Symptom Checklist (TSC), Self-report questionnaire of responses to stressful events on a scale from 0 (never) to 3 (Often) where higher scores indicates greater severity., Baseline, 9-months, 18-months|Patient Health Questionnaire (PHQ), Self-report measure of depression and suicide behaviors from 0 (Not At All) to 3 (Nearly Every Day). Higher scores indicate greater symptom severity., Baseline, 9-months, 18-months|Demographics, Demographic questionnaire including: race, ethnicity, gender identity, sex, and family constellation. Consistent with the PhenX toolkit protocol., Baseline, 9-months, 18-months|Parent Digital Check-In, Weekly self report of SDOH factors (e.g., employment, housing, food security, etc.)., Baseline through 18 months post-Baseline|Clinician Weekly Report, Clinician report of SDOH factors targeted during treatment., through treatment completion, an average of 9 months.|ODHS Administrative Data - case closure, Data related to parent involvement in the ODHS system including date of case closure., Data will be collected for each participant at the end of their participation and include 24 months of data per participant.|ODHS Administrative Data - new referras, Data related to parent involvement in the ODHS system including new hotline reports., Data will be collected for each participant at the end of their participation and include 24 months of data per participant.|County Social Determinants of Health, Publicly available data from participating counties on presence of structural SDOH (no scale), Study Year 2 through Study Year 5; approximately 3 years|Just Care for Families Program Delivery Coding, Expert coding of group supervision sessions (no scale). More (higher) observed skills is an indication of better program delivery., Study Year 2 through Study Year 5; approximately 3 years.|Clinician Identified Participant SDOH needs, Clinicians will report weekly in case documentation participant SDOH needs., Study Year 2 through Study Year 5.|Life Events Checklist (LEC), Self-report measure of lifetime exposure to potentially traumatic experiences. Consistent with the PhenX toolkit protocol., Baseline, 9-months, 18-months|Oregon Health Plan/Medicaid behavioral health encounter data, Administrative data collected to measure long-term prevention outcomes including: l behavioral health encounters related to Opioid/Methamphetamine misuse disorders., Data will be collected for each participant at the end of their participation and include 24 months of data per participant.|Oregon Health Plan/Medicaid medical encounter data, Administrative data collected to measure long-term prevention outcomes including: medical encounters related to Opioid/Methamphetamine misuse disorders., Data will be collected for each participant at the end of their participation and include 24 months of data per participant.|Service delivery and treatment costs, Costs (direct and indirect) associated with delivery of treatment for each patient., through treatment completion, an average of 9 months.|Health Literacy, 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., Baseline, 9-months, 18-months|Major Experiences of Everyday Discrimination, Self-report measure of discrimination experiences and frequency. 10 items where higher is better (less SDOH issues), Baseline, 9-months, 18-months