Clinical trial NCT04678960: Preventing Opioid Use Among Justice-involved Youth As They Transition to Adulthood Leveraging Safe Adults (LeSA)
Official title: Preventing Opioid Use Among Justice-involved Youth As They Transition to Adulthood: Leveraging Safe Adults (LeSA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 360
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Youth days to opioid (and other substance use) initiation
timeFrame: 15 months
measure: Youth months to opioid (and other substance use) initiation
timeFrame: 15 months
measure: Youth substance use severity
timeFrame: 15 months
Secondary outcomes:
measure: Self-regulation (youth) - positive and negative urgency
timeFrame: 15 months
measure: Self-regulation (youth) - delayed discounting
timeFrame: 15 months
measure: Self-regulation (youth) - emotion regulation
timeFrame: 15 months
measure: Self-regulation (youth) - executive functioning
timeFrame: 15 months
measure: Self-efficacy (youth)
timeFrame: 15 months
measure: Social exposure to alcohol, marijuana, heroin, and prescription opioids (youth)
timeFrame: 15 months
measure: Behavioral problems (youth)
timeFrame: 15 months
measure: Prosocial behavior (youth)
timeFrame: 15 months
measure: Monthly check-ins on behavioral misconduct (youth)
timeFrame: 15 months
measure: Anxiety (both youth and caregivers)
timeFrame: 15 months
measure: Depression (both youth and caregivers)
timeFrame: 15 months
measure: Pain (both youth and caregivers)
timeFrame: 15 months
measure: Youth and caregiver relationship
timeFrame: 15 months
measure: Family relationship
timeFrame: 15 months
measure: Monthly check-ins on anxiety, depression, and stress in the relationship with caregiver/safe adult (youth)
timeFrame: 15 months
Other outcomes:
measure: Frequency of receiving substance use treatment
timeFrame: 15 months
measure: Times of hospital visits related to substance use
timeFrame: 15 months
measure: Times of treatment referral for substance use
timeFrame: 15 months
measure: Frequency of opioid overdose
timeFrame: 15 months
measure: Receipt of Narcan for opioid overdose
timeFrame: 15 months
measure: Recidivism
timeFrame: 15 months
measure: Recidivism
timeFrame: 15 months
Locations:
city: Chicago
country: United States
facility: Illinois Youth Center - Chicago
state: Illinois
city: Grafton
country: United States
facility: Illinois Youth Center - Pere Marquette
state: Illinois
city: Harrisburg
country: United States
facility: Illinois Youth Center- Harrisburg
state: Illinois
city: Naperville
country: United States
facility: Illinois Youth Center- Warrenville
state: Illinois
city: St. Charles
country: United States
facility: Illinois Youth Center - St. Charles
state: Illinois
city: Denison
country: United States
facility: Grayson County Juvenile Center/Boot Camp
state: Texas
city: Denison
country: United States
facility: Texas Monarch Academy for Girls/Rite of Passage
state: Texas
city: Georgetown
country: United States
facility: Williamson County Juvenile Services
state: Texas
city: Granbury
country: United States
facility: Lake Granbury Youth Services/Rite of Passage
state: Texas
city: Houston
country: United States
facility: Harris County Youth Village
state: Texas
city: McKinney
country: United States
facility: Collin County Juvenile Probation Services
state: Texas
Study officials:
affiliation: Texas Christian University
name: Danica K Knight, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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