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

C

Chestnut Health Systems

Status

Not yet enrolling

Conditions

Substance Related Disorders

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07365293
2025-60
RM1DA064527 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

254 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Exclusion criteria

-- Alcohol use disorder

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

254 participants in 4 patient groups

No Intervention
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Behavioral: Just Care for Families (JCFF)
Just Care for Families (JCFF) plus App
Experimental group
Description:
Participants will receive the Just Care for Families (JCFF) behavioral intervention in addition to using a JCFF digital support application (App).
Treatment:
Behavioral: Just Care for Families (JCFF) App
Behavioral: Just Care for Families (JCFF)
Just Care for Families (JCFF) plus App plus Feedback
Experimental group
Description:
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.
Treatment:
Behavioral: Just Care for Families (JCFF) App
Behavioral: Just Care for Families (JCFF) App Feedback
Behavioral: Just Care for Families (JCFF)

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Ryan R Sigh, PhD; Rowan M McClelland-Bishop

Data sourced from clinicaltrials.gov

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