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

Opioid Use Clinical Trial

— LeSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04678960
• Other study ID #: UH3DA050250
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Texas Christian University
• Contact: Danica K Knight, Ph.D.
• Phone: 8172574391
• Email: d.knight[@]tcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Substance Use
• Substance-Related Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Illinois Youth Center - Chicago	Chicago	Illinois
United States	Grayson County Juvenile Center/Boot Camp	Denison	Texas
United States	Texas Monarch Academy for Girls/Rite of Passage	Denison	Texas
United States	Williamson County Juvenile Services	Georgetown	Texas
United States	Illinois Youth Center - Pere Marquette	Grafton	Illinois
United States	Lake Granbury Youth Services/Rite of Passage	Granbury	Texas
United States	Illinois Youth Center- Harrisburg	Harrisburg	Illinois
United States	Harris County Youth Village	Houston	Texas
United States	Collin County Juvenile Probation Services	McKinney	Texas
United States	Illinois Youth Center- Warrenville	Naperville	Illinois
United States	Illinois Youth Center - St. Charles	Saint Charles	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	Self-regulation (youth) - delayed discounting	Delay Discounting Task; Scores: 1-13; a higher score indicating a better outcome	15 months
Secondary	Self-regulation (youth) - emotion regulation	Difficulties in Emotion Regulation. Scores: 1-5, a higher score indicating a worse outcome	15 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Depression (both youth and caregivers)	Assessed by the Patient Health Questionnaire (PHQ). Scores: 0-3, a higher score indicating a worse outcome.	15 months
Secondary	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
Secondary	Youth and caregiver relationship	Assessed by the Experiences in Close Relationships. Scores: 1-7, a higher score indicating a worse outcome.	15 months
Secondary	Family relationship	Assessed by the Family Assessment Device. Scores: 1-4, a higher score indicating a better outcome.	15 months
Secondary	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