跳至主要内容
临床试验/NCT04899934
NCT04899934已完成不适用

Multi-Site Feasibility Evaluation of Crisis Stabilization Units Across Three Jurisdictions With High Opioid Use Disorders and a Proposed Follow-Up RCT

Florida State University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Retention of participants

研究概览

简要总结

In this study investigators are examining the feasibility and acceptability of an expanded and technology-assisted aftercare program with persons released from a crisis stabilization unit (CSU) who were brought to the CSU by choice of law enforcement. Investigators are assessing the critical elements of CSUs, examining the feasibility and acceptability of pairing mobile and technology-assisted aftercare to improve treatment access and retention; and developing a study protocol to be used in a future multisite randomized controlled trial (RCT).

Crisis stabilization units provide law enforcement officers an alternative to jail for individuals experiencing a substance use or mental health disorder crisis contributing to criminalized behavior. This study is designed to assist with the diversion of individuals toward treatment and away from subsequent contact with law enforcement through piloting mobile and technology assisted aftercare services to persons released from a CSU. One of the largest barriers to the effectiveness of CSUs is retaining the individual in treatment after discharge. Logistical factors including transportation, stable housing, and long waitlists for community-based treatment decrease treatment access. These factors may also be complicated by an individual's understanding of the importance of remaining in treatment as well as their motivation to continue. To overcome these barriers and enhance the impact of CSUs, investigators are developing an expanded model which includes mobile and technology-assisted modalities that address psychological, behavioral, and medication-assisted treatment.

详细描述

This study is a mixed methods design, combining a randomized controlled trial and qualitative interviews into the feasibility of the pilot program, mobile and technology assisted aftercare. The randomized controlled trial consists of a 1:1 comparison of the pilot CSU aftercare services and the treatment as usual (TAU) services for persons releasing from a CSU.

Participants (n=24) are recruited into the study prior to their discharge from a CSU. Research team members are alerted of potential eligible participants who meet study criteria and are soon-to-be discharged by CSU staff. At this point, research team members approach the eligible participants to conduct the recruitment and consent process. Due to the short length of stay in a CSU, the research team does one-to-one randomization and pre-randomize of the pool of participants prior to recruitment. For example, the pre-randomization may results in Tx Tx Ctrl Tx Ctrl Ctrl assignments for each sequential enrollment in the study. Or it may result in a different pattern Ctrl Txt Ctrl, etc. Participants are notified of their randomization status at the end of the consent and baseline data collection interview.

The pilot program of mobile and technology assisted aftercare service connects participants with a Community Support Specialist (CSS) who provides mobile aftercare (i.e., meet the client in their homes or other community settings) up to once a week for 6 months. Participants also have 24/7 access to behavioral health mobile applications on a smart phone. Mobile apps recommended to participants include, moodtools-depression aid, virtual hope box, recovery path, and intellicare hub. All mobile apps have undergone one or a combination of RCTs, clinical trials, and/or developed with mental health professionals.

Data is collected through participant interviews and collection of health and administrative records from agency collaborators. Participants will complete a total of 4 interviews over a period of 6 months. Baseline interviews will be conducted at study enrollment. Time 1 (T1) interviews will be conducted 2 weeks post-discharge from the CSU. Time 2 (T2) interviews will be conducted 3 months post-discharge from CSU. Time 3 (T3) will be conducted 6 months post-discharge from the CSU. The investigators are monitoring trends in participants during their participation in the pilot program and all consented participants for the treatment and control groups will complete a series of interviews. The assessed trends include readmission to a CSU, employment stability, financial stability, criminal justice involvement, perception of social support, use of acute and long-term services, and multiple psychosocial measures listed below.

Data assessing the feasibility and acceptability of the mobile and technology-assisted aftercare is also assessed through qualitative interviews and focus groups with our community mental health partner. This qualitative data will be used to create a protocol for CSU aftercare that can respond to diverse jurisdictional characteristics leading to CSU aftercare services that are feasible and scalable.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • brought to Meridian Behavioral Health CSU by the choice of law enforcement
  • over 18 years of age
  • self-report to be residing in Alachua, Columbia, or Levy county for at least 6 months following their discharge from the CSU.
  • conversational in English
  • being able to cognitively consent

排除标准

  • younger than 18 years old
  • not cognitively able to consent
  • not conversational in English
  • not releasing from the CSU to Alachua, Columbia, or Levy County, Florida
  • not brought to the CSU by choice of law enforcement

结局指标

主要结局

Retention of participants

时间窗: up to 6 months

Retention of participants is tracked by the number of recruited participants who complete the intervention

Number of participants recruited

时间窗: up to 6 months

Number of eligible participant who agree to participate out of total number of eligible participants

Number of intervention sessions completed

时间窗: up to 6 months

Number of intervention sessions completed is tracked by the number of sessions participants complete over 6 months

次要结局

  • Change in arrest rates(up to 6 months)
  • Frequency of acute service use(up to 6 months)
  • Admission into a crisis stabilization unit(up to 6 months)
  • Frequency of long-term treatment use(up to 6 months)
  • Acceptability of intervention specific aftercare services(up to 12 months)

研究者

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

Carrie Pettus-Davis

associate professor; founder and executive director Institute of Justice Research & Development

Florida State University

研究点 (2)

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