Trust-Based Relational Interventions for Opioid Use Disorder

(LeSA Trial)

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

360 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests TBRI®, a program that helps young people manage emotions and build relationships, for adolescents (15-18) in the juvenile justice system. The program uses trained adults to provide emotional support and guidance, aiming to prevent opioid misuse. Trust-Based Relational Intervention® (TBRI®) is designed to leverage family systems by providing emotional and instrumental guidance, support, and role modeling.

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 data supports the effectiveness of the treatment Trust-Based Relational Interventions for Opioid Use Disorder?

Research shows that the quality of the relationship between a therapist and client, known as the therapeutic bond, can significantly aid recovery from substance use disorders. Studies highlight that strong therapeutic alliances, which are a key component of Trust-Based Relational Interventions, are linked to better outcomes in substance abuse treatments. ^{1 2 3 4 5}

How is Trust-Based Relational Intervention different from other treatments for opioid use disorder?

Trust-Based Relational Intervention (TBRI) is unique because it focuses on building a strong, supportive relationship between the therapist and the patient, which is shown to be important in improving outcomes for substance use disorders. Unlike traditional treatments that may focus solely on medication or behavior change, TBRI emphasizes the therapeutic bond and relational components to facilitate recovery. ^{1 2 3 6 7}

Research Team

Danica K Knight, Ph.D.

Principal Investigator

Texas Christian University

Eligibility Criteria

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.

I am between 15 and 18 years old.

Exclusion Criteria

You are currently at risk of attempting suicide.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of therapeutic bond within a brief intervention for alcohol moderation for problem drinkers. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Patient versus therapist alliance: whose perception matters? [2021]

3. England pubmed.ncbi.nlm.nih.gov

Only connect: The working alliance in computer-based cognitive behavioral therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Network therapy: decreased secondary opioid use during buprenorphine maintenance. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

The therapeutic alliance in adolescent substance abuse treatment: a one-with-many analysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Facilitating outpatient treatment entry following detoxification for injection drug use: a multisite test of three interventions. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The role of therapeutic alliance in network therapy: a family and peer support-based treatment for cocaine abuse. [2015]