CClinicalTrials.gg
RecruitingNCT07365293Updated Apr 17, 2026

Testing Implementation Strategies to Scale-up a Multicomponent Continuum of Service Intervention for Families Involved in Systems With Parental Opioid and Methamphetamine Use

An interventional study of Just Care for Families (JCFF) and Just Care for Families (JCFF) App in Substance Related Disorders, sponsored by Chestnut Health Systems. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Chestnut Health Systems · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
254
Allocation
Randomized
Sex
All
01

Study 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 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/).

02

Conditions studied

  • Substance Related Disorders

Keywords

  • opioid
  • child welfare
  • prevention
  • evidence-based
  • implementation
  • stimulants
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 254 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Chestnut Health Systems is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

-- Alcohol use disorder

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
254 participants (estimated)

Study arms

  • 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.

  • Experimental
    Just Care for Families (JCFF) only

    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.

    Behavioral: Just Care for Families (JCFF)

  • Experimental
    Just Care for Families (JCFF) plus App

    Participants will receive the Just Care for Families (JCFF) behavioral intervention in addition to using a JCFF digital support application (App).

    Behavioral: Just Care for Families (JCFF) · Behavioral: Just Care for Families (JCFF) App

  • Experimental
    Just Care for Families (JCFF) plus App plus Feedback

    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.

    Behavioral: Just Care for Families (JCFF) · Behavioral: Just Care for Families (JCFF) App · Behavioral: Just Care for Families (JCFF) App Feedback

Interventions

  • BehavioralJust 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.

  • BehavioralJust Care for Families (JCFF) App

    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.

  • BehavioralJust Care for Families (JCFF) App Feedback

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 4 months, 9 months, 14 months, and 18 months

  2. 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.

    Time frame: Up to 18 months

  3. 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.

    Time frame: Up to 18 months

  4. Child Welfare Re-Report

    Any new referrals for parent or child as reported in Oregon Department of Human Services Administrative Data.

    Time frame: 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.

    Time frame: Up to 18 months

07

Study locations

1 of 1 sites recruiting
  • Chestnut Health Systems
    Eugene, Oregon 97401, United States
    Recruiting
08

References and documents

Study documents

  • Informed consent form · Oct 29, 2025
  • Informed consent form · Oct 29, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07365293
Lead sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Lisa Saldana (Research Scientist, Chestnut Health Systems) — Principal investigator
First posted
Jan 26, 2026
Start date
Feb 12, 2026
Primary completion
Feb 1, 2030 (estimated)
Completion
May 31, 2030 (estimated)
Last update
Apr 17, 2026

Study contacts

Rowan M McClelland-Bishop
Contact
rmmcclellandbishop@chestnut.org
541-731-3476
Ryan R Sigh, PhD
Contact
rrsingh@chestnut.org
309-451-7748
Lisa Saldana, PhD
principal investigator · Chestnut Health Systems

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion