Clinical trial NCT06651528: Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition
Official title: An Innovative, Trauma-informed Approach for Reducing Overdose Risk Among Women Re-entering the Community From Prison
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorder (SUD)
Keywords: Overdose
Criminal legal system
Trust-based relational intervention (TBRI)
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2024-10-21
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* participating in prison-based SUD treatment program
* have a release date within 3 months
* self-identified history of violent victimization
* have no indication of current suicidal risk,
* able to identify one "Safe Support Person" (SSP) in the community who can be trusted to support recovery and is willing to be contacted about participation

Exclusion Criteria:

* release date greater than 3 months
* no self-identified history of violent victimization
* indication of current suicidal risk
* unable to identify one "Safe Support Person" (SSP) in the community who can be trusted to support recovery and is willing to be contacted about participation

Primary outcomes:
measure: Change in overdose risk
timeFrame: Baseline and at 3 and 6 months post-release from prison
Secondary outcomes:
measure: Change in trauma-related symptoms
timeFrame: Baseline and at 3 and 6 months post-release from prison
Other outcomes:
Locations:
city: Fredonia
country: United States
facility: Western Kentucky Correctional Complex
state: Kentucky
city: Pewee Valley
country: United States
facility: Kentucky Correctional Institution for Women
state: Kentucky
city: Chillicothe
country: United States
facility: Chillicothe Correctional Center
state: Missouri
city: Vandalia
country: United States
facility: Women's Eastern Reception, Diagnostic and Correctional Center
state: Missouri
Study officials:
affiliation: University of Kentucky
name: Michele Staton, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Christian University
name: Kevin Knight, PhD
role: PRINCIPAL_INVESTIGATOR
References: