Substance-Related DisordersNCT06560866
Disrupting SRFOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions
A study testing Just Care for Families in people with Substance-Related Disorders, run by Chestnut Health Systems at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Just Care for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2023to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Clinical Staff:
- clinician at a participating clinic
- Providing Just Care for Families services to parents in the study at any point during study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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/).
Read the 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/).
- Conditions
- Substance-Related Disorders
- Being tested
- Just Care for Families
- Keywords
- social risk factors, opioid, methamphetamine, child welfare, prevention, evidence-based
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just Care for FamiliesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Just Care for Families | Experimental | Parents receiving Just Care for Families Receives: Behavioral: Just Care for Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline through 18 months (weekly)
Secondary outcomes (1)
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.
Measured: Baseline through 18 months (weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start24 Nov 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisa Saldana, Chestnut Health Systems
- Investigators
- Lisa Saldana, PhD, Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560866
- Sponsor's protocol ID
- 1172-0623
- Other IDs
- R01DA057556
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42032776
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disrupting Social Risk Factors of Health to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions
- ClinicalTrials.gov ID
- NCT06560866
- Acronym / sponsor ID
- 1172-0623
- Conditions
- Substance-Related Disorders
- Keywords
- social risk factors, opioid, methamphetamine, child welfare, prevention, evidence-based
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Just Care for Families | Experimental | Behavioral: Just Care for FamiliesParents receiving Just Care for Families |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Just Care for FamiliesJust 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. | Behavioural | Just Care for Families |
Primary outcome
Change in opioid use
Time frame: baseline, 9 months, and 18 months
Changes in any opioid use in past 30 days as assessed by Addiction Severity Index opioid use items (heroin, methadone, and other).
Change in methamphetamine use
Time frame: baseline, 9 months, 18 months
Changes in any methamphetamine use in past 30 days as assessed by Addiction Severity Index.
Change in depression severity
Time frame: Baseline, 9 months and 18 months
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).
Change in anxiety
Time frame: baseline, 9 months, 18 months
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).
Change in Social Risk Factors Needs
Time frame: Baseline through 18 months (weekly)
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.
1 secondary outcome
Changes in opioid or methamphetamine use as measured by Urinalysis testing
Time frame: Baseline through 18 months (weekly)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 42032776Saldana 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Saldana, PhD principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just Care for Families in people with Substance-Related Disorders, run by Chestnut Health Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in opioid use (time frame: baseline, 9 months, and 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.