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

Michele Staton

Status: Invitation-only

Conditions: Substance Use Disorder (SUD)

Treatments: Behavioral: TAU + TRUST + Re-entry Recovery Support; Other: Treatment as Usual (TAU); Behavioral: TAU + TRUST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06651528

R33DA061365 (U.S. NIH Grant/Contract)

94956

Details and patient eligibility

About

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).

Full 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.

Enrollment: 264 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 3 patient groups

Treatment As Usual (TAU)

Active Comparator group

Description:

Traditional in-prison SUD treatment

Treatment:

Other: Treatment as Usual (TAU)

TRUST only

Experimental group

Description:

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

Treatment:

Behavioral: TAU + TRUST

TRUST + Re-entry Recovery Support

Experimental group

Description:

Treatment as usual, the adapted intervention (TRUST), and on-going re-entry recovery support with the Safe Support Person (SSP).

Treatment:

Behavioral: TAU + TRUST + Re-entry Recovery Support