Disrupting SDOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions

Not Applicable

Recruiting

• Conditions: Social Determinants of Health; Substance-Related Disorders
• Interventions: Behavioral: Just Care for Families

• Registration Number: NCT06560866
• Lead Sponsor: Chestnut Health Systems

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-24
• Study First Submitted: 2024-07-10
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2027-10-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Parents:

• Use or misuse of opioids in the last year, and/or any methamphetamine use in the last year
• Parent of a child, age 0-18
• Current mental health symptoms
• Resident of participating county (Lane, Linn, Benton, Douglas, Lincoln)
• Insured by Oregon Health Plan (Medicaid)
• 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

Clinical Staff:

• clinician at a participating clinic
• Providing Just Care for Families services to parents in the study at any point during study

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Just Care for Families	Just Care for Families	Parents receiving Just Care for Families

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chestnut Health Systems; 🇺🇸 Eugene, Oregon, United States