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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use; Opioid Use
• Intervention / Treatment: Behavioral: Trust-based Relational Intervention Training; Behavioral: Trust-based Relational Intervention In-Home Structured Coaching; Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danica K Knight, Ph.D.; Phone Number: 8172574391; Email: d.knight@tcu.edu
• Study Contact Backup: Name: Yang Yang, Ph.D.; Phone Number: 8172574391

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Illinois Youth Center - Chicago
      • Contact: Debi Joy; Phone Number: 630-200-3428; Email: Debi.Joy@Illinois.gov
    • Grafton, Illinois, United States, 62037
      • Recruiting
      • Illinois Youth Center - Pere Marquette
      • Contact: Debi Joy; Phone Number: 630-584-0506; Email: debi.joy@illinois.gov
    • Harrisburg, Illinois, United States, 62946
      • Recruiting
      • Illinois Youth Center- Harrisburg
      • Contact: Debi Joy; Phone Number: 630-200-3428; Email: Debi.Joy@Illinois.gov
    • Naperville, Illinois, United States, 60563
      • Recruiting
      • Illinois Youth Center- Warrenville
      • Contact: Debi Joy; Phone Number: 630-200-3428; Email: Debi.Joy@Illinois.gov
    • Saint Charles, Illinois, United States, 60175
      • Recruiting
      • Illinois Youth Center - St. Charles
      • Contact: Debi Joy; Phone Number: 630-200-3428; Email: Debi.Joy@Illinois.gov
  • Texas
    • Denison, Texas, United States, 75020
      • Recruiting
      • Grayson County Juvenile Center/Boot Camp
      • Contact: Greg Sumpter; Phone Number: 903-786-6326; Email: sumpterg@co.grayson.tx.us
    • Denison, Texas, United States, 75020
      • Recruiting
      • Texas Monarch Academy for Girls/Rite of Passage
      • Contact: Jessica Wade; Phone Number: 903-415-6454; Email: jessica.wade@rop.com
    • Georgetown, Texas, United States, 78626
      • Recruiting
      • Williamson County Juvenile Services
      • Contact: Heather Robison; Phone Number: 512-943-5292; Email: heather.robison@wilco.org
    • Granbury, Texas, United States, 76048
      • Recruiting
      • Lake Granbury Youth Services/Rite of Passage
      • Contact: Angela Lowe; Phone Number: 682-498-6356; Email: angela.lowe@rop.com
    • Houston, Texas, United States, 77586
      • Recruiting
      • Harris County Youth Village
      • Contact: Jennifer Hunley; Phone Number: 713-222-4700; Email: Jennifer.Hunley@hcjpd.hctx.net
    • McKinney, Texas, United States, 75071
      • Recruiting
      • Collin County Juvenile Probation Services
      • Contact: H. Lynn Hadnot; Phone Number: 972-548-6470

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Reentry Practice; 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; 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; 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.; Other Names: TBRI
Experimental: TBRI Training + TBRI In-Home Structured Coaching; 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; 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.; Other Names: TBRI; Behavioral: Trust-based Relational Intervention In-Home Structured Coaching; 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.; Other Names: TBRI Structured Coaching
Experimental: TBRI Training + TBRI In-Home Responsive Coaching; 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; 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.; Other Names: TBRI; Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching; 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.; Other Names: TBRI Responsive Coaching

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of receiving substance use treatment	Frequency of receiving substance use treatment (alcohol, illegal drug use). Scores: 0 (never), 1 (once), or 2 (more than once), a higher score indicating a worse outcome.	15 months
Times of hospital visits related to substance use	Times of hospital visits related to substance use. Scores: 0 - the number of times. A higher score indicating a worse outcome.	15 months
Times of treatment referral for substance use	Times of treatment referral for substance use. Scores: 0 - the number of times. A higher score indicating a worse outcome.	15 months
Frequency of opioid overdose	Frequency of opioid overdose. Scores: 0 (never), 1 (once), or 2 (more than once), a higher score indicating a worse outcome.	15 months
Receipt of Narcan for opioid overdose	Receipt of Narcan for opioid overdose. Scores: 0 (no) or 1 (yes), a score of 1 indicating a worse outcome.	15 months
Recidivism	Whether or not youth are re-arrest (0 = no, 1 = yes) or re-adjudicated (0 = no, 1 = yes). The information will come from JJ agency youth records. A score of 1 indicating a worse outcome.	15 months
Recidivism	Days between discharge and youth's re-arrest and re-adjudication. The information will come from JJ agency youth records. Scores: 0-450 days, a higher score indicating a better outcome.	15 months

Collaborators and Investigators

• Sponsor: Texas Christian University
• Investigators: Principal Investigator: Danica K Knight, Ph.D., Texas Christian University

Publications and helpful links

General Publications

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• Baglivio, M. T., & Epps, N. (2016). The interrelatedness of adverse childhood experiences among high-risk juvenile offenders. Youth Violence and Juvenile Justice, 14(3), 179-198.
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• Evans-Chase, M. (2014). Addressing trauma and psychosocial development in juvenile justice- involved youth: A synthesis of the developmental neuroscience, juvenile justice and trauma literature. Laws, 3(4), 744-758. DOI: 10.3390/laws3040744
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• Forster M, Grigsby TJ, Rogers CJ, Benjamin SM. The relationship between family-based adverse childhood experiences and substance use behaviors among a diverse sample of college students. Addict Behav. 2018 Jan;76:298-304. doi: 10.1016/j.addbeh.2017.08.037. Epub 2017 Sep 1.
• Fosco GM, Frank JL, Stormshak EA, Dishion TJ. Opening the "Black Box": family check-up intervention effects on self-regulation that prevents growth in problem behavior and substance use. J Sch Psychol. 2013 Aug;51(4):455-68. doi: 10.1016/j.jsp.2013.02.001. Epub 2013 Feb 26.
• Frisman, L., Ford, J., Lin, H.-J., Mallon, S., & Chang, R. (2008). Outcomes of trauma treatment using the TARGET Model. https://doi.org/10.1080/15560350802424910
• Hovdestad, W. E., Tonmyr, L., Wekerle, C., & Thornton, T. (2011). Why is childhood maltreatment associated with adolescent substance abuse? A critical review of explanatory models. International Journal of Mental Health Addiction, 9(5), 525-542. DOI: 10.1007/s11469-011-9322-9
• Kumpfer KL, Alvarado R, Whiteside HO. Family-based interventions for substance use and misuse prevention. Subst Use Misuse. 2003 Sep-Nov;38(11-13):1759-87. doi: 10.1081/ja-120024240.
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• Marrow, M. T., Knudsen, K. J., Olafson, E., & Bucher, S. E. (2012). The value of implementing TARGET within a trauma-informed Juvenile Justice Setting. Journal of Child & Adolescent Trauma, 5(3), 257-270. DOI: 10.1080/19361521.2012.697105
• Murray, D. W., Rosanbalm, K., & Christopoulos, C. (2016, February). Self-Regulation and toxic stress report 3: A comprehensive review of self-regulation interventions from birth through young adulthood (OPRE Report # 2016-34). Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. Retrieved February 14, 2019 from https://www.acf.hhs.gov/sites/default/files/opre/acf_report_3_approved_fromword_b508. pdf
• National Center for Mental Health and Juvenile Justice. (2016, September). Trauma among youth in the Juvenile Justice System. Retrieved March 7, 2019 from https://www.ncmhjj.com/wp-content/uploads/2016/09/Trauma-Among-Youth-in-the- Juvenile-Justice-System-for-WEBSITE.pdf
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• Knight DK, Yang Y, Joseph ED, Tinius E, Young S, Shelley LT, Cross DR, Knight K. Preventing opioid use among justice-involved youth as they transition to adulthood: leveraging safe adults (LeSA). BMC Public Health. 2021 Nov 20;21(1):2133. doi: 10.1186/s12889-021-12127-3.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: trauma-informed care; justice-involved youth; prevention for opioid use and other substances; Trust-based relational intervention (TBRI); youth-caregiver relationship
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: UH3DA050250 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All data will be further de-identified (e.g., by systematically scrambling Study IDs within study sites) before being shared with the HEAL Prevention Coordinating Center. The Coordinating Center will not have access to identifying information, nor will they have access to or knowledge of how participant study identification numbers were scrambled.

The data will also be shared publicly, following the HEAL Prevention Guidance for Appropriate Public Access and Data Sharing Plans, including the following aspects:

• Electronic copies of publications will be deposited within 4 weeks of acceptance
• Publications will be published under the Creative Commons Generic License
• Publications will be made publicly available immediately without embargo
• Underlying Primary Data for the Publications will be made broadly available
• Sharing of Underlying Primary Data must be responsive to protecting confidential and proprietary data and is consistent with applicable laws and regulations.

IPD Sharing Time Frame

The data will be shared with the HEAL Prevention Cooperative between 2021 and 2024.

Sharing of underlying primary data for the publications will be made broadly available through an appropriate data repository, such as the NIH HEAL Initiative central data repository, or a non-NIH repository that conforms to the principles articulated in the HEAL Public Access and Data Sharing Policy (referred to in the URL included below).

IPD Sharing Access Criteria

All research teams that participate in the NIH Helping to End Addiction Long-term (HEAL) Initiative.

https://heal.nih.gov/files/2020-01/2020-01-16_data-sharing-4.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No