Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651528
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Innovative Trauma-informed Approach for Reducing Overdose Risk Among Women Re-entering the Community From Prison
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST
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 N30 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 n8 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 Womens Re-entry Approach TBRI-WRA in reducing overdose risk among women N264 in four sites following release from prison-based SUD treatment Study conditions include 1 Treatment as Usual TAU standard in-prison SUD treatment n88 2 In-prison TBRI TAU TBRI prison-based sessions only n88 and 3 TBRI Re-entry Recovery Support TAU prison-based TBRI sessions Re-entry Recovery Support n88 The R33 will also examine implementation factors associated with study preparation launch sustainability and scalability
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 Womens Re-entry Approach TBRI-WRA in reducing overdose risk among women N264 in four sites following release from prison-based SUD treatment Study conditions include 1 Treatment as Usual TAU standard in-prison SUD treatment n88 2 In-prison TBRI TAU TBRI prison-based sessions only n88 and 3 TBRI Re-entry Recovery Support TAU prison-based TBRI sessions Re-entry Recovery Support n88 The R33 will also examine implementation factors associated with study preparation launch sustainability and scalability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None