Substance Related DisordersNCT07365293
Testing Implementation Strategies to Scale-up a Multicomponent Continuum of Service Intervention for Families Involved in Systems With Parental Opioid and Methamphetamine Use
A study testing Just Care for Families (JCFF), Just Care for Families (JCFF) App and Just Care for Families (JCFF) App Feedback in people with Substance Related Disorders, run by Chestnut Health Systems at 1 site in United States.
Trial summary
This study will explore how to expand the Just Care for Families (JCFF) program beyond its current sites in Oregon, while addressing two main challenges: the developer team cannot provide ongoing support to every new program, and rural counties face limits on caseloads and reimbursement because of long travel… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Related Disorders
- What is being tested?
- Just Care for Families (JCFF), Just Care for Families (JCFF) App and Just Care for Families (JCFF) App Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 31 May 2030
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Misuse of opioids and/or stimulants in the last year, including misuse of prescriptions
- parent of a child aged 0-18 with the child living in the home or a reunification plan in place
- residing in one of the nine participating counties
- insured by Medicaid
- access to a computer, smartphone, or wireless/cellular connection if a device were to be provided
- Willing to enroll with the first available Just Care coach
Who cannot join
- -- Alcohol use disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Chestnut Health Systems
Eugene, Oregon, 97401
Melissa Baker, AOR, CRA, 309-451-7855, mkbaker@chestnut.org
Lisa Saldana, PhD, 541-915-6614, lsaldana@chestnut.org
About this study
This study will explore how to expand the Just Care for Families (JCFF) program beyond its current sites in Oregon, while addressing two main challenges: the developer team cannot provide ongoing support to every new program, and rural counties face limits on caseloads and reimbursement because of long travel distances. To overcome these barriers, the trial will test two strategies-using a JCFF mobile app to improve outcomes and efficiency, and relying on trained Experts (instead of the developer team) to guide new counties. With five active counties and four new ones, researchers will study whether parents receiving JCFF with digital support show reduced opioid and stimulant use, better child welfare outcomes like reunification, and more efficient treatment. This study will also compare how well new counties implement JCFF compared to existing ones, and use modeling to see if digital tools help programs sustain themselves by balancing caseloads and reimbursement. 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 Hybrid Type II effectiveness-implementation trial uses an adaptation of a stepped-wedge design to test clinical outcomes spanning interception points within the Child Welfare system and implementation outcomes when Just Care for Families (JCFF) is delivered with the addition of a mobile App with provider feedback about parent App usage. Nine rural Oregon counties, five active counties previously implemented with developer support, and four new counties that will implement with new JCFF Expert support have been recruited to test the clinical effectiveness of JCFF when delivered with and without the App. A total of 254 parents with opioid and/or stimulant use and intersection with the Child Welfare system will be recruited to participate. Parents will receive usual services, JCFF, JCFF with the App, or JCFF with the App and feedback. Longitudinal in-person assessments at baseline, 4-months, 9-months, 14-months, and 18-months, and weekly text assessments of social determinants of health needs and Child Welfare intersection will test the reduction in parent opioid and stimulant use over time with increased treatment engagement, retention, completion and decreased length of Child Welfare case, reentry into treatment, and recidivism (arrest, Child Welfare re-referral). The effectiveness of the JCFF implementation approach will be tested when implemented with the support of new JCFF Experts versus developer Experts, with the aim of equal effectiveness. Clinical and implementation outcomes will be modeled to examine the impact that adding the App could have on program sustainment for rural programs, expanding the potential for JCFF to scale up in Oregon and elsewhere, positioning for public health impact. 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 (JCFF), Just Care for Families (JCFF) App, Just Care for Families (JCFF) App Feedback
- Keywords
- opioid, child welfare, prevention, evidence-based, implementation, stimulants
- 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 Families (JCFF)Behavioural
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 (JCFF) AppBehavioural
Participants will use a Just Care for Families digital support application (App). App features will include interactive tools modeled after those used for in-person interventions and practice exercises. Parent data will be stored within the App, including entered self-report and usage data.
Just Care for Families (JCFF) App FeedbackBehavioural
Coaches will receive feedback on parent's use of the App. Parent-reported current needs, clinical status (e.g., substance use and mental health symptoms), progress, and goals will be programmed into dashboards accessible to assigned Coaches (i.e., Feedback).
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | No services will be offered to participants. Participants are able to engage in any non-Just Care services that they choose, which could include substance use treatment, mental health treatment, child welfare or self-sufficiency case plans that include parenting classes, social services to access basic needs like food stamps, and support to obtain employment. Just Care for Families is not available in the counties during usual services recruitment. |
| Just Care for Families (JCFF) only | Experimental | 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. Receives: Behavioral: Just Care for Families (JCFF) |
| Just Care for Families (JCFF) plus App | Experimental | Participants will receive the Just Care for Families (JCFF) behavioral intervention in addition to using a JCFF digital support application (App). Receives: Behavioral: Just Care for Families (JCFF); Behavioral: Just Care for Families (JCFF) App |
| Just Care for Families (JCFF) plus App plus Feedback | Experimental | Participants will receive the Just Care for Families (JCFF) behavioral intervention, use of the App, and the intervention coaches will receive feedback on parent's use of the App. Receives: Behavioral: Just Care for Families (JCFF); Behavioral: Just Care for Families (JCFF) App; Behavioral: Just Care for Families (JCFF) App Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Opioid and/or Stimulant Use from Baseline to 18 months
Any opioid or stimulant use in the past 30 days as measured by the Addiction Severity Index.
Measured: Baseline, 4 months, 9 months, 14 months, and 18 months
Treatment Engagement
Number of sessions attended as reported by coaches in the Just Portal software used as part of the JCFF delivery and fidelity monitoring.
Measured: Up to 18 months
Treatment Retention
Retained in treatment through completion (i.e. mutual decision between client and coach for how to end treatment). Measured only for the first treatment episode.
Measured: Up to 18 months
Child Welfare Re-Report
Any new referrals for parent or child as reported in Oregon Department of Human Services Administrative Data.
Measured: Up to 18 months
Secondary outcomes (1)
Child Reunification
Any record of child being reunified with parent as reported in Oregon Department of Human Services Administrative Data.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start12 Feb 2026
- Primary completion1 Feb 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Ongoing delivery of JCFF in active counties supports commencement of recruitment upon IRB approval in Year 1. Eligible parents in new counties will be recruited as a no-treatment Usual Services control in Year 1. In Year 2, both active and new clinics will be assigned to two groups, balanced by county social risk factors and child welfare outcomes, and "stepped" from their Year 1 condition to receive JCFF with the addition of the JCFF App (JCFF+ App), and then again, when FB is provided to Coaches (JCFF+App+FB). Parents will be assigned to one of four conditions: JCFF, JCFF + a digital App alone, JCFF + the App and intervention Coach feedback (FB) or usual services. Thus, intervention condition varies over time for counties, teams, and Coaches, but it is a single status for each parent.
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
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
- NCT07365293
- Sponsor's protocol ID
- 2025-60
- Other IDs
- RM1DA064527
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD except for administrative data will be shared. For administrative data, a data use agreement signed by the research team and members of the third party will define the scope of appropriate access and use of the data. While overall or composite scores may be available to share publicly, ethical and legal considerations limit distribution of individual level data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Implementation Strategies to Scale-up a Multicomponent Continuum of Service Intervention for Families Involved in Systems With Parental Opioid and Methamphetamine Use
- ClinicalTrials.gov ID
- NCT07365293
- Acronym / sponsor ID
- 2025-60
- Conditions
- Substance Related Disorders
- Keywords
- opioid, child welfare, prevention, evidence-based, implementation, stimulants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 26 Jan 2026 (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.
This study will explore how to expand the Just Care for Families (JCFF) program beyond its current sites in Oregon, while addressing two main challenges: the developer team cannot provide ongoing support to every new program, and rural counties face limits on caseloads and reimbursement because of long travel distances. To overcome these barriers, the trial will test two strategies-using a JCFF mobile app to improve outcomes and efficiency, and relying on trained Experts (instead of the developer team) to guide new counties. With five active counties and four new ones, researchers will study whether parents receiving JCFF with digital support show reduced opioid and stimulant use, better child welfare outcomes like reunification, and more efficient treatment. This study will also compare how well new counties implement JCFF compared to existing ones, and use modeling to see if digital tools help programs sustain themselves by balancing caseloads and reimbursement. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).
Detailed description
This Hybrid Type II effectiveness-implementation trial uses an adaptation of a stepped-wedge design to test clinical outcomes spanning interception points within the Child Welfare system and implementation outcomes when Just Care for Families (JCFF) is delivered with the addition of a mobile App with provider feedback about parent App usage. Nine rural Oregon counties, five active counties previously implemented with developer support, and four new counties that will implement with new JCFF Expert support have been recruited to test the clinical effectiveness of JCFF when delivered with and without the App. A total of 254 parents with opioid and/or stimulant use and intersection with the Child Welfare system will be recruited to participate. Parents will receive usual services, JCFF, JCFF with the App, or JCFF with the App and feedback. Longitudinal in-person assessments at baseline, 4-months, 9-months, 14-months, and 18-months, and weekly text assessments of social determinants of health needs and Child Welfare intersection will test the reduction in parent opioid and stimulant use over time with increased treatment engagement, retention, completion and decreased length of Child Welfare case, reentry into treatment, and recidivism (arrest, Child Welfare re-referral). The effectiveness of the JCFF implementation approach will be tested when implemented with the support of new JCFF Experts versus developer Experts, with the aim of equal effectiveness. Clinical and implementation outcomes will be modeled to examine the impact that adding the App could have on program sustainment for rural programs, expanding the potential for JCFF to scale up in Oregon and elsewhere, positioning for public health impact. 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Ongoing delivery of JCFF in active counties supports commencement of recruitment upon IRB approval in Year 1. Eligible parents in new counties will be recruited as a no-treatment Usual Services control in Year 1. In Year 2, both active and new clinics will be assigned to two groups, balanced by county social risk factors and child welfare outcomes, and "stepped" from their Year 1 condition to receive JCFF with the addition of the JCFF App (JCFF+ App), and then again, when FB is provided to Coaches (JCFF+App+FB). Parents will be assigned to one of four conditions: JCFF, JCFF + a digital App alone, JCFF + the App and intervention Coach feedback (FB) or usual services. Thus, intervention condition varies over time for counties, teams, and Coaches, but it is a single status for each parent.
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –No services will be offered to participants. Participants are able to engage in any non-Just Care services that they choose, which could include substance use treatment, mental health treatment, child welfare or self-sufficiency case plans that include parenting classes, social services to access basic needs like food stamps, and support to obtain employment. Just Care for Families is not available in the counties during usual services recruitment. |
| Just Care for Families (JCFF) only | Experimental | Behavioral: Just Care for Families (JCFF)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 for Families (JCFF) plus App | Experimental | Behavioral: Just Care for Families (JCFF), Behavioral: Just Care for Families (JCFF) AppParticipants will receive the Just Care for Families (JCFF) behavioral intervention in addition to using a JCFF digital support application (App). |
| Just Care for Families (JCFF) plus App plus Feedback | Experimental | Behavioral: Just Care for Families (JCFF), Behavioral: Just Care for Families (JCFF) App, Behavioral: Just Care for Families (JCFF) App FeedbackParticipants will receive the Just Care for Families (JCFF) behavioral intervention, use of the App, and the intervention coaches will receive feedback on parent's use of the App. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Misuse of opioids and/or stimulants in the last year, including misuse of prescriptions
- parent of a child aged 0-18 with the child living in the home or a reunification plan in place
- residing in one of the nine participating counties
- insured by Medicaid
- access to a computer, smartphone, or wireless/cellular connection if a device were to be provided
Key exclusion criteria (1 listed)
- -- Alcohol use disorder
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 Families (JCFF)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. | Behavioural | Just Care for Families (JCFF) only, Just Care for Families (JCFF) plus App, Just Care for Families (JCFF) plus App plus Feedback |
| Just Care for Families (JCFF) AppParticipants will use a Just Care for Families digital support application (App). App features will include interactive tools modeled after those used for in-person interventions and practice exercises. Parent data will be stored within the App, including entered self-report and usage data. | Behavioural | Just Care for Families (JCFF) plus App, Just Care for Families (JCFF) plus App plus Feedback |
| Just Care for Families (JCFF) App FeedbackCoaches will receive feedback on parent's use of the App. Parent-reported current needs, clinical status (e.g., substance use and mental health symptoms), progress, and goals will be programmed into dashboards accessible to assigned Coaches (i.e., Feedback). | Behavioural | Just Care for Families (JCFF) plus App plus Feedback |
Primary outcome
Change in Opioid and/or Stimulant Use from Baseline to 18 months
Time frame: Baseline, 4 months, 9 months, 14 months, and 18 months
Any opioid or stimulant use in the past 30 days as measured by the Addiction Severity Index.
Treatment Engagement
Time frame: Up to 18 months
Number of sessions attended as reported by coaches in the Just Portal software used as part of the JCFF delivery and fidelity monitoring.
Treatment Retention
Time frame: Up to 18 months
Retained in treatment through completion (i.e. mutual decision between client and coach for how to end treatment). Measured only for the first treatment episode.
Child Welfare Re-Report
Time frame: Up to 18 months
Any new referrals for parent or child as reported in Oregon Department of Human Services Administrative Data.
1 secondary outcome
Child Reunification
Time frame: Up to 18 months
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 17 Apr 2026.
- Just Care for Families (JCFF) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD except for administrative data will be shared. For administrative data, a data use agreement signed by the research team and members of the third party will define the scope of appropriate access and use of the data. While overall or composite scores may be available to share publicly, ethical and legal considerations limit distribution of individual level data.
Related trials for Substance Related Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Alcohol Use Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
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.
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 (JCFF), Just Care for Families (JCFF) App and Just Care for Families (JCFF) App Feedback 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Apr 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?
Contact Rowan M McClelland-Bishop (541-731-3476, rmmcclellandbishop@chestnut.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Opioid and/or Stimulant Use from Baseline to 18 months (time frame: Baseline, 4 months, 9 months, 14 months, and 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.