Trauma-Informed Intervention for Substance Use Disorders

(TRUST Trial)

Not yet recruiting at 4 trial locations

Overseen By Olivia Jones, MSW

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michele Staton

Disqualifiers: Suicidal risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women involved with the criminal legal system reduce their risk of drug overdoses upon returning to their communities. It tests a new approach called the Trust-Based Relational Intervention (TBRI), which focuses on building supportive and trusting relationships. Participants are divided into three groups: one receiving standard prison treatment, another adding the TRUST approach, and a third including ongoing support after release. Women in prison for substance use issues, who have faced violence, and are close to parole might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to explore innovative support methods that could significantly improve their transition back into the community.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Trust-Based Relational Intervention (TBRI) is generally well-tolerated. It helps at-risk children and has been adapted for other groups, such as families dealing with substance use issues. Studies have not identified any major safety concerns, indicating that the intervention is safe for similar situations.

Although the study focuses on women involved with the criminal legal system, the approach builds on successful applications in other groups. Since the study is not in a specific trial phase, specific safety data for this exact group is limited. However, the successful use of TBRI in different populations provides reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trauma-Informed Intervention for Substance Use Disorders because it offers a fresh approach to treatment by integrating trust-building and support mechanisms. Unlike traditional in-prison substance use disorder treatment, this intervention includes the Trust-Based Relational Intervention (TBRI) adapted for adult women, known as the TRUST Intervention, which focuses on creating safe and supportive relationships to aid recovery. Additionally, another arm combines this intervention with ongoing re-entry recovery support, utilizing a Safe Support Person (SSP) to assist women as they transition back into their communities. These elements are designed to address the emotional and relational aspects of recovery, which are often overlooked in standard treatment options. By focusing on these areas, researchers hope to improve outcomes for individuals with substance use disorders.

What evidence suggests that the Trust-Based Relational Intervention (TBRI) could be effective for reducing overdose risk in CLS-involved women?

Studies have shown that Trust-Based Relational Intervention (TBRI) helps people who have experienced trauma. This trauma-informed method considers how past traumas affect current behavior and needs. Research indicates that TBRI has been adapted to help prevent substance use, particularly for at-risk families and individuals. Early results suggest that TBRI aids in building healthier relationships and coping skills, crucial for those dealing with substance use issues. In this trial, participants may receive the adapted version of TBRI, known as the TRUST Intervention, either alone or with additional re-entry recovery support. While most research focuses on young people, the approach is also being adjusted for adults, including those in the criminal justice system. ^{1 2 3 5 6}

Who Is on the Research Team?

Michele Staton, MSW, PhD

Principal Investigator

University of Kentucky

Kevin Knight, PhD

Principal Investigator

Texas Christian University

Are You a Good Fit for This Trial?

This trial is for women with substance use disorders who are transitioning back into the community from the criminal legal system. It's designed to help them reduce their risk of overdose by using a new approach that considers their past trauma.

Inclusion Criteria

I will be released within the next 3 months.

Participating in prison-based SUD treatment program

Self-identified history of violent victimization

Exclusion Criteria

Release date greater than 3 months

No self-identified history of violent victimization

Indication of current suicidal risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase (Intervention adaptation)

Adaptation of the TBRI intervention for CLS-involved women, including prison group sessions and re-entry recovery support

Not specified

R33 Phase (Intervention testing)

Testing the effectiveness of the adapted TBRI-WRA to reduce overdose risk in the community following prison release

6 months

Baseline, 3 months, and 6 months post-release

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Trust-Based Relational Intervention (TBRI)

Trial Overview The study tests an intervention called Trust-Based Relational Intervention (TBRI) combined with Treatment as Usual (TAU) and additional re-entry recovery support, against TBRI alone or just TAU. The goal is to see which method best reduces substance use and supports transition.

How Is the Trial Designed?

Group I: TRUST only Experimental Treatment 1 Intervention

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

Group II: TRUST + Re-entry Recovery Support Experimental Treatment 1 Intervention

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

Group III: Treatment As Usual (TAU) Active Control 1 Intervention

Traditional in-prison SUD treatment

Who Is Running the Clinical Trial?

Michele Staton

Lead Sponsor

Trials

5

Recruited

1,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 98 male veterans with substance use disorders and PTSD, the Seeking Safety therapy led to better drug use outcomes compared to standard treatment, indicating its effectiveness in this population.

Seeking Safety also resulted in higher treatment attendance and patient satisfaction, although the exact mechanism behind its effectiveness in reducing drug use remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. Boden, MT., Kimerling, R., Jacobs-Lentz, J., et al.[2018]

Women who use drugs often face high rates of trauma, which can hinder their access to substance use and harm reduction services, highlighting the need for trauma-informed practices in research and clinical care.

Applying the four principles of trauma-informed practice—awareness of trauma, safety and trust, collaborative choice, and strengths-based approaches—can enhance the inclusion and safety of women who use drugs in substance use research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research With Women Who Use Drugs: Applying a Trauma-informed Framework. Robinson, K., Ickowicz, S.[2023]

This study will evaluate a new trauma-informed care model in a residential treatment service for youth aged 18-35 with substance use disorders and PTSD, focusing on staff training, service adaptations, and client support.

Outcomes will include adherence to the trauma-informed model and client treatment completion, with follow-up assessments on substance use and mental health at multiple time points over a year, aiming to improve treatment retention and outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders. Walter, ZC., Carlyle, M., Kerswell, N., et al.[2023]

Adolescents with a history of trauma are at a higher risk for developing substance use disorders (SUDs), and integrated treatment approaches are necessary to address both trauma and SUDs effectively.

A systematic review of 33 studies, including 13 randomized controlled trials, found that cognitive-behavioral therapy and other therapeutic approaches show promise in treating SUDs in traumatized youth, with exposure-based interventions yielding particularly strong results and minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for prevention and treatment of substance use in youth with traumatic childhood experiences: a systematic review and synthesis of the literature. Becker, TD., Castañeda Ramirez, S., Bruges Boude, A., et al.[2023]

Traumatic life experiences can create a neurobiological vulnerability that increases the risk of developing substance use disorders (SUDs), highlighting the importance of understanding trauma in treatment.

Implementing trauma-informed care in SUD treatment improves patient experiences and retention, suggesting that addressing trauma and stigma can lead to better outcomes for individuals with SUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Necessity of a Trauma-Informed Paradigm in Substance Use Disorder Services. Bartholow, LAM., Huffman, RT.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3877861/

Trust-Based Relational Intervention (TBRI): A Systemic ... Trust-Based Relational Intervention (TBRI) is a therapeutic model that trains caregivers to provide effective support and treatment for at-risk children.

2. child.tcu.edu child.tcu.edu/wp-content/uploads/2024/04/TBRI-Evidence-Summary-2024.pdf

Trust-Based Relational Intervention (TBRI) This document summarizes the published research on TBRI, including studies conducted by the KPICD and by external researchers who may or may ...

3. link.springer.com link.springer.com/article/10.1007/s40653-023-00574-6

Exploring the Effectiveness and Sustainability of Trust ... Participants reported several positives of TBRI®, including self-development and improved outcomes for children. Whilst challenges/barriers to ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924000067

Adaptation of a trauma-informed intervention to prevent ... The current paper describes the systematic adaptation of Trust-Based Relational Intervention (TBRI) as a family-centered substance use prevention program for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04678960

Preventing Opioid Use Among Justice-involved Youth as ... The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe ...

6. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-12127-3

Preventing opioid use among justice-involved youth as they ... The LeSA study is testing TBRI as a means to empower caregivers to help prevent opioid use and other SU among JJ-youth.