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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 will test an intervention to prevent opioid misuse among older adolescents involved in the juvenile justice system.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Youth days to opioid (and other substance use) initiation
Youth months to opioid (and other substance use) initiation
Alcohol or Other Drugs use
Secondary outcome measures
Anxiety (both youth and caregivers)
Behavioral problems (youth)
Depression (both youth and caregivers)
+12 more
Other outcome measures
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).

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.

Find a Location

Who is running the clinical trial?

Texas Christian UniversityLead Sponsor
27 Previous Clinical Trials
3,539 Total Patients Enrolled
Danica K Knight, Ph.D.Principal InvestigatorTexas Christian University
1 Previous Clinical Trials
839 Total Patients Enrolled

Media Library

Trust-based Relational Intervention Group Training Clinical Trial Eligibility Overview. Trial Name: NCT04678960 — N/A
Substance Abuse Research Study Groups: Standard Reentry Practice, TBRI Training only, TBRI Training + TBRI In-Home Structured Coaching, TBRI Training + TBRI In-Home Responsive Coaching
Substance Abuse Clinical Trial 2023: Trust-based Relational Intervention Group Training Highlights & Side Effects. Trial Name: NCT04678960 — N/A
Trust-based Relational Intervention Group Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678960 — N/A
~9 spots leftby Aug 2024