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

Texas Christian University

Status: Completed

Conditions: Substance Use; Opioid Use

Treatments: Behavioral: Trust-based Relational Intervention Training; Behavioral: Trust-based Relational Intervention In-Home Structured Coaching; Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04678960

UH3DA050250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 15 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

Standard Reentry Practice

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Behavioral: Trust-based Relational Intervention Training

TBRI Training + TBRI In-Home Structured Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Trust-based Relational Intervention In-Home Structured Coaching

Behavioral: Trust-based Relational Intervention Training

TBRI Training + TBRI In-Home Responsive Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Trust-based Relational Intervention In-Home Responsive Coaching

Behavioral: Trust-based Relational Intervention Training