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

NCT06560866 | Recruiting

• 2 other identifiers: 1172-0623R01DA057556
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 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.

Conditions

Substance-Related Disorders

Keywords

social risk factors; opioid; methamphetamine; child welfare; prevention; evidence-based

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

EXPERIMENTAL

Parents receiving Just Care for Families

Behavioral: Just Care for Families

Interventions

Just Care for Families 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.

Just Care for Families

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chestnut Health Systems: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Chestnut Health Systems

Eugene, Oregon, 97401, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa Saldana, PhD

  Chestnut Health Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylee knbecker@chestnut.org, PhD

CONTACT

888-655-9641; lsaldana@chestnut.org

Ryan Singh, PhD

CONTACT

541-844-8532; rrsingh@chestnut.org

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

Model Details: 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.

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.

Locations

US (1)