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Clinical Trials/NCT06651528
NCT06651528Enrolling By InvitationNot Applicable

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

Michele Staton7 sites in 1 country264 target enrollmentStarted: December 9, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
264
Locations
7
Primary Endpoint
Change in overdose risk

Study Overview

Brief 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).

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Treatment As Usual (TAU)

Active Comparator

Traditional in-prison SUD treatment

Intervention: Treatment as Usual (TAU) (Other)

TRUST only

Experimental

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

Intervention: 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).

Intervention: TAU + TRUST + Re-entry Recovery Support (Behavioral)

Outcomes

Primary Outcomes

Change in overdose risk

Time Frame: 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

Secondary Outcomes

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

Investigators

Sponsor
Michele Staton
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Michele Staton

Professor

University of Kentucky

Study Sites (7)

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