NCT07365293

Brief 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/).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026May 2030

First Submitted

Initial submission to the registry

January 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

April 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

January 22, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

opioidchild welfarepreventionevidence-basedimplementationstimulants

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Up to 18 months

Secondary Outcomes (1)

  • Child Reunification

    Up to 18 months

Study Arms (4)

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.

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).

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.

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

Interventions

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) onlyJust Care for Families (JCFF) plus AppJust Care for Families (JCFF) plus App plus 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).

Just Care for Families (JCFF) plus App plus Feedback

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) plus AppJust Care for Families (JCFF) plus App plus Feedback

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \-- Alcohol use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Health Systems

Eugene, Oregon, 97401, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Lisa Saldana, PhD

    Chestnut Health Systems

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rowan M McClelland-Bishop

CONTACT

Ryan R Sigh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 26, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

May 31, 2030

Last Updated

April 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 6 months after closing baseline data collection with no end date
Access Criteria
Data will be shared in accordance with the NIH Helping to End Addiction Long-term (HEAL) Initiative Public Access and Data Sharing Policy. All data will be submitted to the NAHDAP repository and will be findable and accessible through the HEAL Initiative Data Ecosystem. All data will also be submitted to the NIDA-funded Methodology and Advanced Analytics Resource Center (MAARC) located at the University of Chicago, a data commons built for the purpose of sharing research data collected by research "hubs" within the NIDA-funded Justice Community Overdose Innovation Network (JCOIN). Data will be shared with investigators working under an institution with Federal Wide Assurance (FWA) and could be used for secondary study purposes. Requested primary study data and metadata (e.g., format and organization) will be made available to investigators according to the policies of the University of Chicago MAARC and the NAHDAP repository.
More information

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