Trust-Based Relational Interventions for Opioid Use Disorder

(LeSA Trial)

No longer recruiting at 12 trial locations

Overseen By Danica K Knight, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Texas Christian University

Disqualifiers: Outside age range, Active suicide risk

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Trust-Based Relational Intervention (TBRI) to help prevent opioid misuse in older teenagers involved in the juvenile justice system. The goal is to evaluate the effectiveness of different TBRI support types for these teens and their caregivers, including training sessions and home coaching. Participants will either follow standard reentry practices or receive one of three TBRI support plans: Trust-Based Relational Intervention Group Training, Trust-Based Relational Intervention In-Home Responsive Coaching, or Trust-Based Relational Intervention In-Home Structured Coaching. The trial seeks teens aged 15-18 who are on probation after time in a juvenile justice facility and have a supportive adult willing to join the study. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for teens and their caregivers.

Will I have to stop taking my current medications?

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

What prior data suggests that Trust-based Relational Interventions are safe for preventing opioid misuse among juvenile justice-involved youth?

Research has shown that Trust-Based Relational Intervention® (TBRI®) is a well-received approach. TBRI helps young people manage their emotions and build healthy relationships by focusing on family and attachment, strengthening bonds between youth and caregivers.

Previous studies have found TBRI to be a good fit for families, with participants generally reporting positive experiences and no major issues. This approach involves coaching and training rather than medication, avoiding the physical side effects that drugs might cause.

Although this study doesn't provide data on negative effects, the emphasis on training and relationship-building suggests few safety concerns. This makes TBRI a promising option for those seeking supportive interventions with low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Trust-Based Relational Interventions (TBRI) for opioid use disorder because they offer a unique approach centered on building trust and relationships, unlike traditional treatments that often focus solely on medication and behavioral therapy. TBRI emphasizes personalized coaching and support, both before and after an individual’s release, which is not commonly found in standard care. The integration of caregiver and youth modules, along with role-play activities, aims to strengthen the support system around those struggling with opioid use, potentially leading to more sustainable recovery outcomes. Additionally, the option for in-home coaching provides tailored support that adapts to the individual needs of the participants, offering a more flexible and responsive treatment model.

What evidence suggests that this trial's treatments could be effective for preventing opioid misuse in JJ-involved youth?

Research has shown that Trust-Based Relational Intervention (TBRI) may help young people, particularly those in the juvenile justice system, avoid starting or increasing opioid use. This trial will evaluate different TBRI approaches, including TBRI Training only, TBRI Training with In-Home Structured Coaching, and TBRI Training with In-Home Responsive Coaching. TBRI focuses on building healthy relationships and providing support through planned activities and guidance. Studies have found that TBRI can help caregivers lower the risk of substance use in youth by creating a stable and supportive environment. Early reports suggest this approach reduces risky behaviors by teaching both caregivers and youth how to handle trauma and stress. Overall, TBRI aims to create positive change by emphasizing connection and guidance. ^{2 3 6 7 8}

Who Is on the Research Team?

Danica K Knight, Ph.D.

Principal Investigator

Texas Christian University

Are You a Good Fit for This Trial?

This trial is for youth aged 15-18 involved in the juvenile justice system who are transitioning to community supervision after at least 2 months in a secure facility. They must have a safe adult willing to participate and no active suicide risk. Staff working with these youths on the project can also join.

Inclusion Criteria

Being disposed to community supervision (i.e., probation) following a minimum of 2 months in the secure residential JJ facility

Being able to identify one safe adult that is willing to participate in the study.

You are not currently at risk of harming yourself.

Exclusion Criteria

You are currently at risk of attempting suicide.

I do not fall within the specified age range for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-release Intervention

Youth/safe adult dyads participate in TBRI caregiver and youth modules, and Nurture Groups prior to youth's release

Varies

Multiple sessions (in-person)

Post-release Support

After release, youth receive phone support or in-home coaching sessions based on the trial arm

4 months

4 visits (in-person) or as needed (phone support)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Monthly check-ins

What Are the Treatments Tested in This Trial?

Interventions

• Trust-based Relational Intervention Group Training
• Trust-based Relational Intervention In-Home Responsive Coaching
• Trust-based Relational Intervention In-Home Structured Coaching
• Trust-based Relational Intervention Training

Trial Overview The study tests Trust-based Relational Intervention (TBRI) methods, including training for staff and two types of coaching for youth, aimed at preventing opioid misuse as these young individuals move from juvenile facilities back into their communities.

How Is the Trial Designed?

Group I: TBRI Training only Experimental Treatment 1 Intervention

Youth/safe adult dyads participate in 9 TBRI caregiver modules (caregivers only), 9 youth modules (youth only), and 4 Nurture Groups (caregiver and youth joint role-play activities) prior to youth's release. After the youth's release, they would receive phone support (only when requested by the caregiver or youth).

Group II: TBRI Training + TBRI In-Home Structured Coaching Experimental Treatment 2 Interventions

Youth/safe adult dyads participate in 9 TBRI caregiver modules (caregivers only), 9 youth modules (youth only), and 4 Nurture Groups (caregiver and youth joint role-play activities) prior to youth's release. After youth's release, trained TCU TBRI Practitioners provide coaching sessions to youth/safe adult dyads in which they meet 4 times (once monthly) over the first 4 months following release.

Group III: TBRI Training + TBRI In-Home Responsive Coaching Experimental Treatment 2 Interventions

Youth/safe adult dyads participate in 9 TBRI caregiver modules (caregivers only), 9 youth modules (youth only), and 4 Nurture Groups (caregiver and youth joint role-play activities) prior to youth's release. After youth's release, trained TCU TBRI Practitioners provide coaching sessions to youth/safe adult dyads. They meet a minimum of 2 times during the first 2 months after release. Starting from Month 3, TBRI Practitioners would provide additional coaching when requested or when a research assistant (RA) identifies a need for additional coaching sessions.

Group IV: Standard Reentry Practice Active Control 1 Intervention

Youth/safe adult participants only receive assessments (baseline assessment while youth are at the facility; 3, 6, 12, 18 months follow-up assessments after youth are released from the facility).

Who Is Running the Clinical Trial?

Texas Christian University

Lead Sponsor

Trials

31

Recruited

4,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04678960

Preventing Opioid Use Among Justice-involved Youth as ... The current study proposes to adapt and test an intervention Trust-based Relational Intervention® (TBRI®) for preventing initiation and/or escalation of opioid ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8605598/

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.

3. 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 ...

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

Exploring the Effectiveness and Sustainability of Trust ... This paper presents the findings of a small-scale study which explored early childhood professionals' perceptions of the effectiveness and sustainability of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11413274/

Feasibility and Acceptability of a Trauma-informed ... The current study tested the feasibility of a prevention intervention, Trust-based Relational Intervention® (TBRI®), that leverages family ...

7. 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.

8. withpower.com withpower.com/trial/phase-substance-related-disorders-1-2021-11674

Trust-Based Relational Interventions for Opioid Use ... This trial tests TBRI®, a program that helps young people manage emotions and build relationships, for adolescents (15-18) in the juvenile justice system.