Clinical trial NCT06560866: Disrupting SDOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions
Official title: Disrupting Social Determinants of Health to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Determinants of Health
Substance-Related Disorders
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-19
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion Criteria:

Primary outcomes:
measure: Social Determinants of Health
timeFrame: Baseline, 9 months and 18 months
measure: Urine Drug Screens
timeFrame: Baseline, 9 months and 18 months
measure: Brief Symptom Inventory (BSI)
timeFrame: Baseline, 9 months and 18 months post-baseline
measure: Trauma Symptom Checklist (TSC)
timeFrame: Baseline, 9-months, 18-months
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline, 9-months, 18-months
measure: Demographics
timeFrame: Baseline, 9-months, 18-months
measure: Parent Digital Check-In
timeFrame: Baseline through 18 months post-Baseline
measure: Clinician Weekly Report
timeFrame: through treatment completion, an average of 9 months.
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.
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.
measure: County Social Determinants of Health
timeFrame: Study Year 2 through Study Year 5; approximately 3 years
measure: Just Care for Families Program Delivery Coding
timeFrame: Study Year 2 through Study Year 5; approximately 3 years.
measure: Clinician Identified Participant SDOH needs
timeFrame: Study Year 2 through Study Year 5.
measure: Life Events Checklist (LEC)
timeFrame: Baseline, 9-months, 18-months
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.
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.
measure: Service delivery and treatment costs
timeFrame: through treatment completion, an average of 9 months.
measure: Health Literacy
timeFrame: Baseline, 9-months, 18-months
measure: Major Experiences of Everyday Discrimination
timeFrame: Baseline, 9-months, 18-months
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Chestnut Health Systems
state: Oregon
Study officials:
affiliation: Chestnut Health Systems
name: Lisa Saldana, PhD
role: PRINCIPAL_INVESTIGATOR
References: