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临床试验/NCT06651528
NCT06651528Enrolling By Invitation不适用

An Innovative, Trauma-informed Approach for Reducing Overdose Risk Among Women Re-entering the Community From Prison

Michele Staton7 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2025年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
264
试验地点
7
主要终点
Change in overdose risk

研究概览

简要总结

The overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI).

详细描述

R61 Phase (Intervention adaptation): The TBRI intervention will be strategically adapted for CLS-involved women during the R61 to achieve 2 specific aims: 1) Adapt TBRI by focusing on adapting two intervention components - prison group sessions and re-entry recovery support - using focus groups with key stakeholders (N=30) including administrators, practitioners, and women with "lived experience," and target alignment with the unique treatment needs of the women and establish intervention approach feasibility; and 2) Pilot test the adapted intervention components in one group of women (n=8) at the KCIW facility. Final adaptations will be made to the TRUST manual for the R33 implementation.

R33 Phase (Intervention testing): The R33 will test the effectiveness of the adapted TBRI-WRA to reduce overdose risk in the community following prison release, while also collecting data on key constructs hypothesized to influence successful intervention implementation. The primary aim of the R33 is to examine effectiveness of the adapted TBRI Women's Re-entry Approach (TBRI-WRA) in reducing overdose risk among women (N=264) in four sites following release from prison-based SUD treatment. Study conditions include (1) Treatment as Usual (TAU, standard in-prison SUD treatment, n=88), (2) In-prison TBRI (TAU + TBRI prison-based sessions only; n=88), and (3) TBRI + Re-entry Recovery Support (TAU + prison-based TBRI sessions + Re-entry Recovery Support; n=88). The R33 will also examine implementation factors associated with study preparation, launch, sustainability, and scalability.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •participating in corrections-based SUD treatment
  • •have an anticipated parole eligibility date within 4 months
  • •self-identified history of violent victimization
  • •are willing to work with at least one person living in the community who will be supportive of your recovery when you get out
  • •interested in participating in the study

排除标准

  • •not participating in corrections-based SUD treatment
  • •anticipated parole eligibility date greater than 4 months
  • •no self-identified history of violent victimization
  • •not willing to work with at least one person living in the community who will be supportive of your recovery when you get out
  • •not interested in participating in the study

研究组 & 干预措施

Treatment As Usual (TAU)

Active Comparator

Traditional in-prison SUD treatment

干预措施: Treatment as Usual (TAU) (Other)

TRUST only

Experimental

Treatment as usual and the adapted version of TBRI for adult women (TRUST Intervention)

干预措施: TAU + TRUST (Behavioral)

TRUST + Re-entry Recovery Support

Experimental

Treatment as usual, the adapted intervention (TRUST), and on-going re-entry recovery support with the Safe Support Person (SSP).

干预措施: TAU + TRUST + Re-entry Recovery Support (Behavioral)

结局指标

主要结局

Change in overdose risk

时间窗: Baseline and at 3 and 6 months post-release from prison

Change in number of days of any substance from baseline to post-release using self-report data

次要结局

  • Change in trauma-related symptoms(Baseline and at 3 and 6 months post-release from prison)

研究者

发起方
Michele Staton
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele Staton

Professor

University of Kentucky

研究点 (7)

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