An Innovative, Trauma-informed Approach for Reducing Overdose Risk Among Women Re-entering the Community From Prison
| Registry | NCT06651528, acronym TRUST |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 264 (Estimated) |
| Sponsor | Michele Staton (Other); collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
| Conditions | Substance Use Disorder (SUD) |
| Interventions | TAU + TRUST, TAU + TRUST + Re-entry Recovery Support, Treatment as Usual (TAU) (Behavioral, other) |
| Dates | start 2025-12-09, primary completion 2029-09-30 (estimated), completion 2029-09-30 (estimated), first posted 2024-10-21, last updated 2026-06-09 |
| Locations | 4 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Substance Use Disorder (SUD) All trials of TAU + TRUST All trials of TAU + TRUST + Re-entry Recovery Support
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU) | Traditional in-prison SUD treatment |
| TRUST only | Experimental | Behavioral: TAU + TRUST | Treatment as usual and the adapted version of TBRI for adult women (TRUST Intervention) |
| TRUST + Re-entry Recovery Support | Experimental | Behavioral: TAU + 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). |
Sex: Female, ages: 18 Years to 99 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Franklin County Regional Jail | Frankfort, Kentucky | United States | |
| Kentucky Correctional Institution for Women | Pewee Valley, Kentucky | United States | |
| Chillicothe Correctional Center | Chillicothe, Missouri | United States | |
| Women's Eastern Reception, Diagnostic and Correctional Center | Vandalia, Missouri | United States |
NIH grants: R33DA061365