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

Обзор

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/).

Подробное описание

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/).

Вмешательства

• Поведенческое 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 skil
• Поведенческое Just 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.
• Поведенческое Just 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).

Первичные конечные точки

• Change in Opioid and/or Stimulant Use from Baseline to 18 months [Срок оценки: Baseline, 4 months, 9 months, 14 months, and 18 months]
• Treatment Engagement [Срок оценки: Up to 18 months]
• Treatment Retention [Срок оценки: Up to 18 months]
• Child Welfare Re-Report [Срок оценки: Up to 18 months]

Вторичные конечные точки (1)

• Child Reunification [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

\-- Alcohol use disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Chestnut Health Systems — Eugene

Идентификаторы

NCT: NCT07365293 · 2025-60 · RM1DA064527

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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