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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA057556 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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 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/).
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/).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Just Care for Families | Experimental | Parents receiving Just Care for Families |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Parents:
Clinical Staff:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Saldana, PhD | Chestnut Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chestnut Health Systems | Eugene | Oregon | 97401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42032776 | Derived | Saldana L, Cruden G, Chapman JE, Singh RR, Jaramillo J, Dir A, Campbell M, Peterson JM, Bybee M, Radich J, Becker K, Spain M, Schaper H, Glass JE. Observational trial of the preventive impact of a social risk factor focused program for co-occurring opioid and methamphetamine use disorders and suicide risk in parents: study protocol. Addict Sci Clin Pract. 2026 Apr 24;21(1):39. doi: 10.1186/s13722-026-00667-1. |
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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.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2024 | Apr 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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