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

Part of paid clinical trials in Frankfort, Kentucky.

Sponsor
Michele Staton
Study ID
NCT06651528
Status
Enrolling By Invitation

Conditions

  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • TAU + TRUST — BEHAVIORAL
    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.
  • TAU + TRUST + Re-entry Recovery Support — BEHAVIORAL
    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).
  • Treatment as Usual (TAU) — OTHER
    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.

Study Details

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).

Key Dates

Start date
Dec 9, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment As Usual (TAU)
    Traditional in-prison SUD treatment
  • Experimental: TRUST only
    Treatment as usual and the adapted version of TBRI for adult women (TRUST Intervention)
  • Experimental: TRUST + Re-entry Recovery Support
    Treatment as usual, the adapted intervention (TRUST), and on-going re-entry recovery support with the Safe Support Person (SSP).

Primary Outcome Measure

Change in overdose risk [ Time Frame: Baseline and at 3 and 6 months post-release from prison ]

Locations (4)

FacilityCityStateZIPSite coordinators
Franklin County Regional JailFrankfortKentucky40601-
Kentucky Correctional Institution for WomenPewee ValleyKentucky40056-
Chillicothe Correctional CenterChillicotheMissouri64601-
Women's Eastern Reception, Diagnostic and Correctional CenterVandaliaMissouri63382-

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