Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition
NCT ID: NCT06651528
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
264 participants
INTERVENTIONAL
2025-12-31
2029-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment As Usual (TAU)
Traditional in-prison SUD treatment
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.
TRUST only
Treatment as usual and the adapted version of TBRI for adult women (TRUST Intervention)
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.
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).
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).
Interventions
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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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* no self-identified history of violent victimization
* indication of current suicidal risk
* 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
18 Years
99 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institutes of Health (NIH)
NIH
Michele Staton
OTHER
Responsible Party
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Michele Staton
Professor
Principal Investigators
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Michele Staton, MSW, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Kevin Knight, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Christian University
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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94956
Identifier Type: -
Identifier Source: org_study_id