跳至主要内容
临床试验/NCT07365293
NCT07365293招募中不适用

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

Chestnut Health Systems1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2026年2月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
254
试验地点
1
主要终点
Change in Opioid and/or Stimulant Use from Baseline to 18 months

研究概览

简要总结

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/).

详细描述

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/).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • -- Alcohol use disorder

研究组 & 干预措施

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) 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.

干预措施: Just Care for Families (JCFF) App (Behavioral)

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.

干预措施: Just Care for Families (JCFF) (Behavioral)

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).

干预措施: Just Care for Families (JCFF) (Behavioral)

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).

干预措施: Just Care for Families (JCFF) App (Behavioral)

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.

干预措施: Just Care for Families (JCFF) (Behavioral)

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.

干预措施: Just Care for Families (JCFF) App Feedback (Behavioral)

结局指标

主要结局

Change in Opioid and/or Stimulant Use from Baseline to 18 months

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Up to 18 months

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

次要结局

  • Child Reunification(Up to 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Saldana

Research Scientist

Chestnut Health Systems

研究点 (1)

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