Opioid UseLeSANCT04678960
Preventing Opioid Use Among Justice-involved Youth as They Transition to Adulthood Leveraging Safe Adults (LeSA)
A study testing Trust-based Relational Intervention Training, Trust-based Relational Intervention In-Home Structured Coaching and Trust-based Relational Intervention In-Home Responsive Coaching in people with Opioid Use and Substance Use, run by Texas Christian University at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Opioid Use, Substance Use
- What is being tested?
- Trust-based Relational Intervention Training, Trust-based Relational Intervention In-Home Structured Coaching and Trust-based Relational Intervention In-Home Responsive Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 11 sitesUnited States
- Study dates
- 15 Feb 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Youth outside the age range described above
- Active suicide risk at the time of recruitment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Illinois Youth Center - Chicago
Chicago, Illinois, 60612
Grayson County Juvenile Center/Boot Camp
Denison, Texas, 75020
Texas Monarch Academy for Girls/Rite of Passage
Denison, Texas, 75020
Williamson County Juvenile Services
Georgetown, Texas, 78626
Illinois Youth Center - Pere Marquette
Grafton, Illinois, 62037
Lake Granbury Youth Services/Rite of Passage
Granbury, Texas, 76048
Illinois Youth Center- Harrisburg
Harrisburg, Illinois, 62946
Harris County Youth Village
Houston, Texas, 77586
Collin County Juvenile Probation Services
McKinney, Texas, 75071
Illinois Youth Center- Warrenville
Naperville, Illinois, 60563
Illinois Youth Center - St. Charles
St. Charles, Illinois, 60175
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use, Substance Use
- Being tested
- Trust-based Relational Intervention Training, Trust-based Relational Intervention In-Home Structured Coaching, Trust-based Relational Intervention In-Home Responsive Coaching
- Keywords
- trauma-informed care, justice-involved youth, prevention for opioid use and other substances, Trust-based relational intervention (TBRI), youth-caregiver relationship
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trust-based Relational Intervention TrainingBehavioural
Also called TBRI
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.
Trust-based Relational Intervention In-Home Structured CoachingBehavioural
Also called TBRI 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.
Trust-based Relational Intervention In-Home Responsive CoachingBehavioural
Also called TBRI 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Reentry Practice | No 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). |
| TBRI Training only | Experimental | 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). Receives: Behavioral: Trust-based Relational Intervention Training |
| TBRI Training + TBRI In-Home Structured Coaching | Experimental | 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. Receives: Behavioral: Trust-based Relational Intervention Training; Behavioral: Trust-based Relational Intervention In-Home Structured Coaching |
| TBRI Training + TBRI In-Home Responsive Coaching | Experimental | 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. Receives: Behavioral: Trust-based Relational Intervention Training; Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 15 months
Secondary outcomes (15)
Self-regulation (youth) - positive and negative urgency
TCU Adolescent Thinking Forms (TCU THK); Scores: 10-50; a higher score indicating a worse outcome
Measured: 15 months
Self-regulation (youth) - delayed discounting
Delay Discounting Task; Scores: 1-13; a higher score indicating a better outcome
Measured: 15 months
Self-regulation (youth) - emotion regulation
Difficulties in Emotion Regulation. Scores: 1-5, a higher score indicating a worse outcome
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 15 months
Depression (both youth and caregivers)
Assessed by the Patient Health Questionnaire (PHQ). Scores: 0-3, a higher score indicating a worse outcome.
Measured: 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.
Measured: 15 months
Youth and caregiver relationship
Assessed by the Experiences in Close Relationships. Scores: 1-7, a higher score indicating a worse outcome.
Measured: 15 months
Family relationship
Assessed by the Family Assessment Device. Scores: 1-4, a higher score indicating a better outcome.
Measured: 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).
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Feb 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danica K Knight, Ph.D., Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678960
- Sponsor's protocol ID
- UH3DA050250
- Acronym
- LeSA
- Status last verified
- Dec 2025
- First submitted
- 11 Nov 2020
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Biederman J, Faraone SV, Monuteaux MC, Feighner JA. Patterns of alcohol and drug use in adolescents can be predicted by parental substance use disorders. Pediatrics. 2000 Oct;106(4):792-7. doi: 10.1542/peds.106.4.792.
PubMed 11015524Baglivio, 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.
Baglivio, M. T., Wolff, K. T., Piquero, A. R., & Epps, N. (2015). The relationship between Adverse Childhood Experiences (ACE) and juvenile offending trajectories in a juvenile offender sample. Journal of Criminal Justice, 43(3), 229-241.
Belenko S, Johnson ID, Taxman FS, Rieckmann T. Probation Staff Attitudes Toward Substance Abuse Treatment and Evidence-Based Practices. Int J Offender Ther Comp Criminol. 2018 Feb;62(2):313-333. doi: 10.1177/0306624X16650679. Epub 2016 May 23.
PubMed 27220361Brockie TN, Dana-Sacco G, Wallen GR, Wilcox HC, Campbell JC. The Relationship of Adverse Childhood Experiences to PTSD, Depression, Poly-Drug Use and Suicide Attempt in Reservation-Based Native American Adolescents and Young Adults. Am J Community Psychol. 2015 Jun;55(3-4):411-21. doi: 10.1007/s10464-015-9721-3.
PubMed 25893815Brown LK, Tarantino N, Tolou-Shams M, Esposito-Smythers C, Healy MG, Craker L. Mental Health Symptoms and Parenting Stress of Parents of Court-Involved Youth. J Child Fam Stud. 2018 Mar;27(3):843-852. doi: 10.1007/s10826-017-0923-1. Epub 2017 Nov 6.
PubMed 29805245Colder CR, Shyhalla K, Frndak SE. Early alcohol use with parental permission: Psychosocial characteristics and drinking in late adolescence. Addict Behav. 2018 Jan;76:82-87. doi: 10.1016/j.addbeh.2017.07.030. Epub 2017 Jul 25.
PubMed 28772246Council of State Governments Justice Center. (2017, September). Dos and don'ts for reducing recidivism among young adults in the justice system. Retrieved February 15, 2019 from https://csgjusticecenter.org/wp-content/uploads/2017/09/Dos-and-Donts-for-Reducing- Recidivism-among-Young-Adults-in-the-Justice-System.pdf
Dube SR, Miller JW, Brown DW, Giles WH, Felitti VJ, Dong M, Anda RF. Adverse childhood experiences and the association with ever using alcohol and initiating alcohol use during adolescence. J Adolesc Health. 2006 Apr;38(4):444.e1-10. doi: 10.1016/j.jadohealth.2005.06.006.
PubMed 16549308Evans-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
Ford, J. D., & Hawke, J. (2012). Trauma affect regulation psychoeducation group and milieu intervention outcomes in juvenile detention facilities. Journal of Aggression, Maltreatment & Trauma, 21(4), 365-384. https://doi.org/10.1080/10926771.2012.673538
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.
PubMed 28889058Fosco 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.
PubMed 23870441Frisman, 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Opioid Use Among Justice-involved Youth as They Transition to Adulthood: Leveraging Safe Adults (LeSA)
- ClinicalTrials.gov ID
- NCT04678960
- Acronym / sponsor ID
- LeSA / UH3DA050250
- Conditions
- Opioid Use, Substance Use
- Keywords
- trauma-informed care, justice-involved youth, prevention for opioid use and other substances, Trust-based relational intervention (TBRI), youth-caregiver relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Standard Reentry Practice | No 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). |
| TBRI Training only | Experimental | Behavioral: Trust-based Relational Intervention TrainingYouth/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). |
| TBRI Training + TBRI In-Home Structured Coaching | Experimental | Behavioral: Trust-based Relational Intervention Training, Behavioral: Trust-based Relational Intervention In-Home Structured CoachingYouth/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. |
| TBRI Training + TBRI In-Home Responsive Coaching | Experimental | Behavioral: Trust-based Relational Intervention Training, Behavioral: Trust-based Relational Intervention In-Home Responsive CoachingYouth/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. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Youth outside the age range described above
- Active suicide risk at the time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trust-based Relational Intervention TrainingAlso: TBRIThe 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. | Behavioural | TBRI Training + TBRI In-Home Responsive Coaching, TBRI Training + TBRI In-Home Structured Coaching, TBRI Training only |
| Trust-based Relational Intervention In-Home Structured CoachingAlso: TBRI Structured CoachingThe 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. | Behavioural | TBRI Training + TBRI In-Home Structured Coaching |
| Trust-based Relational Intervention In-Home Responsive CoachingAlso: TBRI Responsive CoachingThe 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. | Behavioural | TBRI Training + TBRI In-Home Responsive Coaching |
Primary outcome
Youth days to opioid (and other substance use) initiation
Time frame: 15 months
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.
Youth months to opioid (and other substance use) initiation
Time frame: 15 months
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.
Youth substance use severity
Time frame: 15 months
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 secondary outcomes
Self-regulation (youth) - positive and negative urgency
Time frame: 15 months
Self-regulation (youth) - delayed discounting
Time frame: 15 months
Self-regulation (youth) - emotion regulation
Time frame: 15 months
Self-regulation (youth) - executive functioning
Time frame: 15 months
Self-efficacy (youth)
Time frame: 15 months
Social exposure to alcohol, marijuana, heroin, and prescription opioids (youth)
Time frame: 15 months
Behavioral problems (youth)
Time frame: 15 months
Prosocial behavior (youth)
Time frame: 15 months
Monthly check-ins on behavioral misconduct (youth)
Time frame: 15 months
Anxiety (both youth and caregivers)
Time frame: 15 months
Depression (both youth and caregivers)
Time frame: 15 months
Pain (both youth and caregivers)
Time frame: 15 months
Youth and caregiver relationship
Time frame: 15 months
Family relationship
Time frame: 15 months
Monthly check-ins on anxiety, depression, and stress in the relationship with caregiver/safe adult (youth)
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 11015524Biederman J, Faraone SV, Monuteaux MC, Feighner JA. Patterns of alcohol and drug use in adolescents can be predicted by parental substance use disorders. Pediatrics. 2000 Oct;106(4):792-7. doi: 10.1542/peds.106.4.792.
- BackgroundBaglivio, 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.
- BackgroundBaglivio, M. T., Wolff, K. T., Piquero, A. R., & Epps, N. (2015). The relationship between Adverse Childhood Experiences (ACE) and juvenile offending trajectories in a juvenile offender sample. Journal of Criminal Justice, 43(3), 229-241.
- Background: PubMed 27220361Belenko S, Johnson ID, Taxman FS, Rieckmann T. Probation Staff Attitudes Toward Substance Abuse Treatment and Evidence-Based Practices. Int J Offender Ther Comp Criminol. 2018 Feb;62(2):313-333. doi: 10.1177/0306624X16650679. Epub 2016 May 23.
- Background: PubMed 25893815Brockie TN, Dana-Sacco G, Wallen GR, Wilcox HC, Campbell JC. The Relationship of Adverse Childhood Experiences to PTSD, Depression, Poly-Drug Use and Suicide Attempt in Reservation-Based Native American Adolescents and Young Adults. Am J Community Psychol. 2015 Jun;55(3-4):411-21. doi: 10.1007/s10464-015-9721-3.
- Background: PubMed 29805245Brown LK, Tarantino N, Tolou-Shams M, Esposito-Smythers C, Healy MG, Craker L. Mental Health Symptoms and Parenting Stress of Parents of Court-Involved Youth. J Child Fam Stud. 2018 Mar;27(3):843-852. doi: 10.1007/s10826-017-0923-1. Epub 2017 Nov 6.
- Background: PubMed 28772246Colder CR, Shyhalla K, Frndak SE. Early alcohol use with parental permission: Psychosocial characteristics and drinking in late adolescence. Addict Behav. 2018 Jan;76:82-87. doi: 10.1016/j.addbeh.2017.07.030. Epub 2017 Jul 25.
- BackgroundCouncil of State Governments Justice Center. (2017, September). Dos and don'ts for reducing recidivism among young adults in the justice system. Retrieved February 15, 2019 from https://csgjusticecenter.org/wp-content/uploads/2017/09/Dos-and-Donts-for-Reducing- Recidivism-among-Young-Adults-in-the-Justice-System.pdf
- Background: PubMed 16549308Dube SR, Miller JW, Brown DW, Giles WH, Felitti VJ, Dong M, Anda RF. Adverse childhood experiences and the association with ever using alcohol and initiating alcohol use during adolescence. J Adolesc Health. 2006 Apr;38(4):444.e1-10. doi: 10.1016/j.jadohealth.2005.06.006.
- BackgroundEvans-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
- BackgroundFord, J. D., & Hawke, J. (2012). Trauma affect regulation psychoeducation group and milieu intervention outcomes in juvenile detention facilities. Journal of Aggression, Maltreatment & Trauma, 21(4), 365-384. https://doi.org/10.1080/10926771.2012.673538
- Background: PubMed 28889058Forster 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danica K Knight, Ph.D. principal investigator
Texas Christian University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trust-based Relational Intervention Training, Trust-based Relational Intervention In-Home Structured Coaching and Trust-based Relational Intervention In-Home Responsive Coaching in people with Opioid Use and Substance Use, run by Texas Christian University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth days to opioid (and other substance use) initiation (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678960, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.