What side effects are associated with this type of intervention?

Common treatments for substance abuse that focus on building trust and healthy relationships, such as cognitive-behavioral therapy (CBT), family therapy, and behavioral couples therapy, generally have minimal physical side effects. However, patients may experience emotional discomfort as they confront and work through challenging issues. Some individuals might feel increased anxiety or stress during the initial stages of therapy. Additionally, there can be a risk of strained family or partner relationships as underlying issues are addressed. Overall, these therapies are considered safe and beneficial for long-term recovery.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of substance abuse, particularly opioid use disorder, including naltrexone, buprenorphine, and methadone. These medications are often used in conjunction with psychosocial interventions that focus on building trust and healthy relationships, similar to the principles of Trust-based Relational Intervention® (TBRI®). For instance, naltrexone is used alongside addiction counseling and mutual help groups, while buprenorphine is recommended with adjunctive psychosocial treatments. These combined approaches aim to provide comprehensive support, addressing both the physiological and relational aspects of recovery.

What other types of research exist?

Promising novel alternatives to TBRI® for substance abuse patients include: 1) Cognitive Behavioral Therapy (CBT), which has shown efficacy in various settings and delivery methods, including face-to-face and online formats. 2) Contingency Management, which uses positive reinforcement to encourage abstinence. 3) Motivational Interviewing, a patient-centered approach that enhances motivation to change. 4) Behavioral Couples Therapy (BCT), which involves the patient's partner in the treatment process to improve outcomes. 5) Web-based behavioral treatments, which offer flexibility and accessibility for patients who may face barriers to traditional therapy.

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Trust-Based Relational Interventions for Opioid Use Disorder (LeSA Trial)

N/A

Recruiting

Led By Danica K Knight, Ph.D.

Research Sponsored by Texas Christian University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Youth ages 15-18 at study enrollment

Be younger than 65 years old

Must not have

Youth outside the age range described above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves behavioral coaching rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or stress during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 15 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Youth days to opioid (and other substance use) initiation

Youth months to opioid (and other substance use) initiation

Alcohol or Other Drugs use

Secondary study objectives

Anxiety (both youth and caregivers)

Behavioral problems (youth)

Depression (both youth and caregivers)

+12 more

Other study objectives

Frequency of opioid overdose

Frequency of receiving substance use treatment

Receipt of Narcan for opioid overdose

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: TBRI Training onlyExperimental Treatment1 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 CoachingExperimental Treatment2 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 CoachingExperimental Treatment2 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 PracticeActive Control1 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).

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for substance abuse, such as Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and Family Therapy, focus on altering maladaptive behaviors and thought patterns, enhancing motivation for change, and improving family dynamics. CBT helps patients recognize and change harmful behaviors and thought processes, MI enhances intrinsic motivation by resolving ambivalence towards change, and Family Therapy improves communication and support within the family unit. These mechanisms are crucial as they address the psychological and social factors contributing to substance abuse, fostering a supportive environment that promotes recovery and reduces the risk of relapse.

Psychotherapeutic treatment of opiate addiction.