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

NCT06651528 | Enrolling By Invitation DMC

• 2 other identifiers: 94956R33DA061365
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 4

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).

Conditions

Substance Use Disorder (SUD)

Keywords

Overdose; Criminal legal system; Trust-based relational intervention (TBRI)

Outcome Measures

Primary Outcomes (1)

• Change in overdose risk

  Change in number of days of any substance from baseline to post-release using self-report data

  Baseline and at 3 and 6 months post-release from prison

Secondary Outcomes (1)

• Change in trauma-related symptoms

  Baseline and at 3 and 6 months post-release from prison

Study Arms (3)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Traditional in-prison SUD treatment

Other: Treatment as Usual (TAU)

TRUST only

EXPERIMENTAL

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

Behavioral: TAU + TRUST

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).

Behavioral: TAU + TRUST + Re-entry Recovery Support

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.

TRUST only

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).

TRUST + Re-entry Recovery Support

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.

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Michele Staton: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Franklin County Regional Jail

Frankfort, Kentucky, 40601, United States

Location

Kentucky Correctional Institution for Women

Pewee Valley, Kentucky, 40056, United States

Location

Chillicothe Correctional Center

Chillicothe, Missouri, 64601, United States

Location

Women's Eastern Reception, Diagnostic and Correctional Center

Vandalia, Missouri, 63382, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Drug Overdose

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse

Study Officials

• Michele Staton, MSW, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Kevin Knight, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: December 9, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)