Preventing Opioid Use Among Justice-involved Youth as They Transition to Adulthood Leveraging Safe Adults (LeSA)

Study Overview
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Brief Summary
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Across the US, substance use is a significant public health concern, with juvenile justice (JJ)-involved youth representing a particularly vulnerable population. The current study proposes to adapt and test an intervention Trust-based Relational Intervention® (TBRI®) for preventing initiation and/or escalation of opioid misuse among older adolescents involved in the JJ system. Successful completion of study aims will provide information on TBRI's utility for older JJ adolescents, barriers and facilitators of sustainment, and provide training and implementation support for sustainment in participating facilities.

Detailed Description
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Across the US, substance use (SU) is a significant public health concern, with an estimated 11.1 million misusing prescription opioids. Rates of opioid use disorders (OUDs) have increased exponentially, with 60% of overdoses attributed to heroin and illicit synthetics (such as Fentanyl). Although opioid use among youth is low compared to adults, experimentation and regular use increases later in adolescence as youth transition to adulthood. Juvenile justice (JJ)-involved youth represent a particularly vulnerable population, as they often experience mental health disorders, dysfunctional family/social relationships, and complex trauma, placing them at greater risk for SU and substance use disorders (SUDs). To ensure that these youth do not become another opioid statistic, innovative and effective prevention interventions are needed. The investigators propose to adapt and test an intervention for preventing initiation and/or escalation of opioid misuse among older JJ-involved adolescents. The target enrollment group will be youth aging out of JJ (15-18 years at study enrollment) who are transitioning to their communities after a period of detainment in a secure treatment or correctional facility. Trust-based Relational Intervention® (TBRI®; a relational, attachment-based intervention that promotes emotional regulation through interaction with responsive adults) will be adapted as a prevention intervention targeting youth at risk for SU (especially non-medical use of opioids). Safe adults (e.g., parent/guardian, extended family member) will be trained in behavior management techniques for empowering youth to appropriately express their needs, connecting them with others in pro-social ways, and correcting or reshaping undesirable behavior. The proposed Effectiveness/Implementation study will examine both the effectiveness of TBRI for preventing opioid misuse and the comparative utility of three support formats: (1) TBRI Training only, (2) TBRI Training + Structured Coaching, or (3) TBRI Training + Responsive Coaching (triggered by the youth's need/risk). A total of 360 youth/safe adult dyads will be recruited from 9 participating JJ facilities over a 3-year period, and followed for 18 months post-release (15 youth-adult dyads/year per facility). This design enables a comparison of TBRI versus Standard Reentry Practice (SRP; using a stepped-wedge design where each facility serves as its own control) plus a randomized control trial comparing 3 TBRI support formats. This study will also examine barriers and facilitators of TBRI sustainment. Ninety JJ staff (10 from each agency) will provide input annually via focus groups and surveys. TCU will work with administrators and staff at each JJ facility to implement a sustainment plan, which will include developing in-house TBRI expertise (i.e., staff training and implementation assistance). Successful completion of study aims will provide a test of the adapted intervention and will facilitate sustainment by providing training and implementation support to participating facilities.

Official Title
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Preventing Opioid Use Among Justice-involved Youth as They Transition to Adulthood: Leveraging Safe Adults (LeSA)

Conditions
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Opioid Use, Substance Use

Intervention / Treatment
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* Behavioral: Trust-based Relational Intervention Training
* Behavioral: Trust-based Relational Intervention In-Home Structured Coaching
* Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the effectiveness component, Youth ages 15-18 at study enrollment Being disposed to community supervision (i.e., probation) following a minimum of 2 months in the secure residential JJ facility No indication of active suicide risk Being able to identify one safe adult that is willing to participate in the study. For the implementation component: • All staff with direct care or supervisory responsibilities within and outside the facilities (i.e., officers supervising youth after release) working with TCU on the LeSA project. Exclusion Criteria: Youth outside the age range described above Active suicide risk at the time of recruitment

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An effectiveness-Implementation Hybrid Design - Type 1; Randomized controlled trial and delayed-start study testing the effectiveness of Trust-based Relational Intervention and three different support formats (no coaching/structured coaching/adaptive coaching) among Juvenile Justice (JJ)-involved youth transitioning to their communities and a safe adult (e.g. parent/guardian, extended family member). In the delayed-start design, JJ agencies are randomly assigned to four different starting points with two months apart for starting the project. The last 18-months of the delayed-start design will provide a naturalistic investigation of sustainment of the intervention within the facilities after responsibility for intervention delivery has been transferred from TCU to the JJ agencies (TCU provide trainings to foster in-house TBRI expertise and assistance for implementation).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Reentry Practice<br>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). | |
| Experimental: TBRI Training only<br>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). | Behavioral: Trust-based Relational Intervention Training<br>* The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI Group Training is comprised of three components: TBRI Youth Group Training (youth only), Caregiver Training (caregivers only), and Nurture Groups (youth-caregiver joint roleplay activities), which is conducted prior to youth's release.<br>* Other names: TBRI;|
| Experimental: TBRI Training + TBRI In-Home Structured Coaching<br>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. | Behavioral: Trust-based Relational Intervention Training<br>* The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI Group Training is comprised of three components: TBRI Youth Group Training (youth only), Caregiver Training (caregivers only), and Nurture Groups (youth-caregiver joint roleplay activities), which is conducted prior to youth's release.<br>* Other names: TBRI;Behavioral: Trust-based Relational Intervention In-Home Structured Coaching<br>* The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI In-Home Structured Training includes four structured in-home coaching sessions.<br>* Other names: TBRI Structured Coaching;|
| Experimental: TBRI Training + TBRI In-Home Responsive Coaching<br>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. | Behavioral: Trust-based Relational Intervention Training<br>* The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI Group Training is comprised of three components: TBRI Youth Group Training (youth only), Caregiver Training (caregivers only), and Nurture Groups (youth-caregiver joint roleplay activities), which is conducted prior to youth's release.<br>* Other names: TBRI;Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching<br>* The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching. TBRI In-Home Responsive Training includes at least 2 structured in-home coaching sessions plus additional sessions indefinitely as needed.<br>* Other names: TBRI Responsive Coaching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth days to opioid (and other substance use) initiation | Initiation to opioid and other substance use (e.g., alcohol, marijuana, methamphetamine) over 15 months follow-up in days, measured by the scale of Timeline follow-back, Substance Use Involvement (i.e., during the past 30 days, how many days did you use alcohol or drugs; developed by the HEAL Prevention Cooperative), urinalysis results. Scores: 0-450 days; a higher score indicating a better outcome. | 15 months | 
| Youth months to opioid (and other substance use) initiation | Initiation to opioid and other substance use over 15 months follow-up in months, monthly check-ins (any opioid use; any alcohol, other drug use in the past month). Scores: 0-15 months; a higher score indicating a better outcome. | 15 months | 
| Youth substance use severity | Opioid use and other substance use (e.g., alcohol, marijuana, methamphetamine) over 15 months; measured by TCU Drug Screen 5 and TCU Drug Screen 5 - Opioid Supplement. Scores: 0-11, a higher score indicating a worse outcome. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-regulation (youth) - positive and negative urgency | TCU Adolescent Thinking Forms (TCU THK); Scores: 10-50; a higher score indicating a worse outcome | 15 months | 
| Self-regulation (youth) - delayed discounting | Delay Discounting Task; Scores: 1-13; a higher score indicating a better outcome | 15 months | 
| Self-regulation (youth) - emotion regulation | Difficulties in Emotion Regulation. Scores: 1-5, a higher score indicating a worse outcome | 15 months | 
| Self-regulation (youth) - executive functioning | Barkley Deficits in Executive Functioning Scale-Child and Adolescent Short Form. Scores: 1-4, a higher score indicating a worse outcome. | 15 months | 
| Self-efficacy (youth) | Two items (developed by the HEAL Prevention Cooperative) assessing how confident participants not misuse prescription or heroin in the next 30 days. Scores: 0-4, a higher score indicating a better outcome | 15 months | 
| Social exposure to alcohol, marijuana, heroin, and prescription opioids (youth) | Four items, developed by the HEAL Prevention Cooperative, to assess social exposure to alcohol, marijuana, heroin, and prescription opioids (i.e., how often the adult who is most important to the participant drink alcohol or use marijuana, heroin, and prescription opioids). Scores: 0-3, a higher score indicating a worse outcome | 15 months | 
| Behavioral problems (youth) | Behavioral problems in the areas of peer problems, hyperactivity, emotional problems, and conduct problems, assessed by the Strength and Difficulties Questionnaire. Scores: 0-40, a higher score indicating a worse outcome | 15 months | 
| Prosocial behavior (youth) | Prosocial behavior is assessed by the Prosocial subscale of the Strength and Difficulties Questionnaire. Scores: 0-10, a higher score indicating a better outcome. | 15 months | 
| Monthly check-ins on behavioral misconduct (youth) | Monthly check-ins asking any truancy, trouble with the law during the last month. Scores: 0 (no) or 1 (yes, being involved in the behavioral misconduct). | 15 months | 
| Anxiety (both youth and caregivers) | Assessed by the General Anxiety Disorder (GAD) -7. Scores: 0-3, a higher score indicating a worse outcome. | 15 months | 
| Depression (both youth and caregivers) | Assessed by the Patient Health Questionnaire (PHQ). Scores: 0-3, a higher score indicating a worse outcome. | 15 months | 
| Pain (both youth and caregivers) | Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain domain. Scores: 0-3, a higher score indicating a worse outcome. | 15 months | 
| Youth and caregiver relationship | Assessed by the Experiences in Close Relationships. Scores: 1-7, a higher score indicating a worse outcome. | 15 months | 
| Family relationship | Assessed by the Family Assessment Device. Scores: 1-4, a higher score indicating a better outcome. | 15 months | 
| Monthly check-ins on anxiety, depression, and stress in the relationship with caregiver/safe adult (youth) | Monthly check-ins asking any increase in anxiety, depression, or stress in the relationship with caregiver/safe adult. Scores: 0 (no) or 1 (yes, there is an increase in the past month). | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma-informed care, justice-involved youth, prevention for opioid use and other substances, Trust-based relational intervention (TBRI), youth-caregiver relationship