Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition
NCT06651528 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264
Last updated 2026-02-20
Summary
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).
Conditions
- Substance Use Disorder (SUD)
Interventions
- BEHAVIORAL
-
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 tailored skills training reflected by anticipated differences in the target population of women - including how their early attachment and trauma histories influence their current self-image and behavior (which likely has a tremendous impact on their relational attachments as adults). Group sessions will provide opportunities to build skills for regulating emotions and building healthy connections.
- BEHAVIORAL
-
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 identified home placement. This individual will be identified by the study participant as someone who is not involved in active substance use nor has a current legal system status (e.g., on probation).
- OTHER
-
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 an on-going systematic or relational perspective and are not specifically addressed as part of re-entry planning.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
National Institutes of Health (NIH)
collaborator NIH -
Michele Staton
lead OTHER
Principal Investigators
-
Michele Staton, MSW, PhD · University of Kentucky
-
Kevin Knight, PhD · Texas Christian University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-09
- Primary Completion
- 2029-09-30
- Completion
- 2029-09-30
Countries
- United States
Study Locations
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