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

Disrupting Social Risk Factors of Health to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions

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 risk factors of health (SRFOH). In addition, investigators will examine the impacts of SRFOH 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. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).

Study Overview

• Status: Active, not recruiting
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Behavioral: Just Care for Families

Detailed Description

This study provides multiple tests of the mechanisms by which Just Care for Families disrupts the effects of lifetime social risk factors of health (SRFOH) 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 SRFOH (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 SRFOH, such as community poverty and healthcare service availability. Additionally, system dynamics will be used to examine patterns of influence between SRFOH and Just Care for Families intervention targets, case outcomes, and associated costs. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Chestnut Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Parents:

• Any substance misuse in the last year
• Parent of a child, age 0-18
• 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:

• Alcohol use disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Just Care for Families; Parents receiving Just Care for Families

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in opioid use	Changes in any opioid use in past 30 days as assessed by Addiction Severity Index opioid use items (heroin, methadone, and other).	baseline, 9 months, and 18 months
Change in methamphetamine use	Changes in any methamphetamine use in past 30 days as assessed by Addiction Severity Index.	baseline, 9 months, 18 months
Change in depression severity	Changes in intensity of depression-related distress in the past week as measured by the Brief Symptom Inventory Depression Subscale items (Sum of responses to 6 Likert-type items, range 0-24).	Baseline, 9 months and 18 months
Change in anxiety	Changes in intensity of anxiety-related distress in the past week as measured by the Brief Symptom Inventory Anxiety Subscale items (Sum of responses to 6 Likert-type items, range 0-24).	baseline, 9 months, 18 months
Change in Social Risk Factors Needs	Changes in total number of needs or problems across Social Risk Factors of Health domains as assessed by PhenX toolkit items in a weekly parent survey. The number of items endorsed in the past week out of 43 items comprising 7 risk factor domains are scored. Domains include Work and money, neighborhood and transportation, education and training, food, community safety and support, healthcare system, internet and phone, and health and well-being.	Baseline through 18 months (weekly)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in opioid or methamphetamine use as measured by Urinalysis testing	Positive urine drug screen for opioids or methamphetamines as measured by 12-panel instant urine toxicology screens and fentanyl strip screens.	Baseline through 18 months (weekly)

Collaborators and Investigators

• Sponsor: Chestnut Health Systems
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lisa Saldana, PhD, Chestnut Health Systems

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: opioid; prevention; methamphetamine; evidence-based; child welfare; social risk factors
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1172-0623; R01DA057556 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, this study will follow the data sharing protocols as outlined by the HEAL Data Sharing Policy.
• IPD Sharing Time Frame: Data will be shared upon acceptance of the data for publication or within six months after the completion of Baseline data collection (within 12 months for the 9-month and 18-month assessments), whichever is earlier.
• IPD Sharing Access Criteria: Data will be deposited in the NAHDAP data repository. These data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes. Requested primary study data and metadata will be made available to investigators according to the policies of the NAHDAP.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No