Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое TAU + TRUST
  The adapted TBRI WRA (Prison Only Component) titled TRUST will consist of an individual introductory module (1 hour) and a series of group modules (a minimum of 4 sessions, approximately 1-2 hours in length, delivered over the course of 3 months, with the final number and frequency to be determined in R61) focused on the core components of TBRI. The original TBRI approach includes a focus on group skills training; similarly, it is anticipated that R61 phase adaptations will meet the need for tai
• Поведенческое TAU + TRUST + Re-entry Recovery Support
  This condition includes the proposed adapted TRUST intervention as well as on-going re-entry recovery support with the Safe Support Person (SSP). The SSP will be identified by the study participant as someone who will provide prosocial support during re-entry (e.g., support towards abstinence, establishing healthy recovery support relationships, rebuilding relationships with family and children) and in most cases will involve a close family member (mother, grandmother) or friend at the woman's i
• Другое Treatment as Usual (TAU)
  Women in the TAU condition will not receive TRUST intervention services, but will receive traditional in-prison SUD treatment over 6 months as usual in the four targeted prison sites. The programs are separate units with the prisons and emphasize participation by all program members in the overall goal of addressing substance use and criminal thinking. Although trauma and violence are addressed as part of the holistic group process approach in these programs, these topics are not addressed from

Первичные конечные точки

• Change in overdose risk [Срок оценки: Baseline and at 3 and 6 months post-release from prison]

Вторичные конечные точки (1)

• Change in trauma-related symptoms [Срок оценки: Baseline and at 3 and 6 months post-release from prison]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Franklin County Regional Jail — Frankfort
• Kentucky Correctional Institution for Women — Pewee Valley
• Chillicothe Correctional Center — Chillicothe
• Women's Eastern Reception, Diagnostic and Correctional Center — Vandalia

Публикации

• Staton M, Annett J, Carey P, Yang Y, Jones O, Bills L, Logan TK, Tillson M, Oser C, Knight K. Trauma-informed intervention to reduce substance use and to support community transition [TRUST]: Study protocol for a type 1 effectiveness-implementation hybrid trial to reduce overdose risk among justice-involved women. Trials. 2026 Apr 20;27(1):406. doi: 10.1186/s13063-026-09715-2. PMID 42010616

Идентификаторы

NCT: NCT06651528 · 94956 · R33DA061365

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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