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
2 other identifiers
interventional
266
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2023
CompletedFirst Submitted
Initial submission to the registry
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2028
February 9, 2026
August 1, 2025
3.9 years
July 10, 2024
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Changes in opioid or methamphetamine use as measured by Urinalysis testing
Baseline through 18 months (weekly)
Study Arms (1)
Just Care for Families
EXPERIMENTALParents receiving Just Care for Families
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Alcohol use disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chestnut Health Systemslead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Chestnut Health Systems
Eugene, Oregon, 97401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Saldana, PhD
Chestnut Health Systems
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
July 10, 2024
First Posted
August 19, 2024
Study Start
November 24, 2023
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
January 30, 2028
Last Updated
February 9, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.