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

NCT ID: NCT06560866

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2028-01-30

Brief Summary

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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

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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.

Conditions

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Social Determinants of Health Substance-Related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Just Care for Families

Parents receiving Just Care for Families

Group Type EXPERIMENTAL

Just Care for Families

Intervention Type BEHAVIORAL

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.

Interventions

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Just Care for Families

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Chestnut Health Systems

OTHER

Sponsor Role lead

Responsible Party

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Lisa Saldana

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Saldana, PhD

Role: PRINCIPAL_INVESTIGATOR

Chestnut Health Systems

Locations

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Chestnut Health Systems

Eugene, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Saldana, PhD

Role: CONTACT

541-915-6614

Ryan Singh, PhD

Role: CONTACT

541-844-8532

Facility Contacts

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Melissa Baker

Role: primary

309-451-7855

Lisa Saldana, PhD

Role: backup

541-915-6614

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DA057556

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1172-0623

Identifier Type: -

Identifier Source: org_study_id

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