Clinical trial NCT05834881: Reducing Drug Use in Justice-Involved Emerging Adults
Official title: Reducing Opioid and Other Drug Use in Justice-Involved Emerging Adults Using Paraprofessional Coaches (With and Without Lived Experience) to Deliver Effective Services in a Non-Treatment Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overarching purpose of this pilot study is to investigate an increasingly common, but under-researched, practice of employing paraprofessional coaches to improve emerging adults' access to and engagement in evidence-based substance use practices, focusing on the paraprofessional coaches' outcomes and the role of lived experience.

Detailed description: Criminal legal system involved emerging adults are one of the highest-risk populations for opioid and other substance use and other significant problems (criminal behaviors), but they lack access to and engagement in evidence-based practices. The deleterious outcomes and long-term costs of substance use for emerging adults, communities, and society (estimated at over $740 billion annually and greater than costs for any other health problem), make this a priority. This pilot project is aimed at using paraprofessional coaches to increase engagement and access to evidence-based practices (i.e., contingency management for substance use and vocational/educational coaching) for emerging adults with substance use and criminal legal system involvement. In partnership with parole and probation, sixty emerging adults with substance use will be randomized to work with twenty paraprofessional coaches either with or without lived experience (i.e., successful substance use recovery and/or adult criminal legal system involvement). Although using peer paraprofessional coaches (those with lived experience) is becoming more popular and supported at the federal level, the outcome of this work on the paraprofessional coaches themselves, especially for emerging adults, is largely unexplored. The proposed study will use both quantitative and qualitative methods to assess feasibility and acceptability of the services and research protocols and to gain a better understanding of the impacts on both the coaches and their emerging adult clients. As substance use and poor vocational/educational attainment greatly increases the likelihood of recidivism, innovative strategies to reduce opioid and other substance use for emerging adults is critical, along with understanding the effects on the service providers (i.e., paraprofessional coaches). Aim 1: Determine the feasibility of paraprofessional coaches to deliver (with high adherence) the established interventions to emerging adults with substance use and criminal legal system involvement as part of probation and parole services, and explore differences in the delivery of the interventions based on lived experience. Aim 2: Compare emerging adult clients' engagement (attendance, completion of the intervention) and outcomes (substance use, vocational/educational attainment, criminal recidivism), when interventions are delivered by paraprofessional coaches with vs. without lived experience. Aim 3: For paraprofessional coaches delivering the interventions, examine the differences over time between those with vs. without lived experience on their own substance use symptoms and substance use relapse risk factors.

Eligibility criteria: There are two types of participants in this study: (1) Paraprofessional Coaches and (2) Emerging Adult Clients

Paraprofessional Coach Eligibility Criteria

Inclusion:

-Between 18-30 years old

Exclusion:

-Life threatening or unstable condition requiring treatment (e.g., suicidal/homicidal ideation)

Emerging Adult Client Eligibility Criteria

Inclusion:

* 18-26 years old
* Have current or historical lived experience with the juvenile or adult criminal legal system (e.g., probation, parole, diversion, deflection).
* Screen positive for substance use disorder

Exclusion:

* Qualifying for federal disability benefits which would preclude them from engaging in educational/vocational coaching
* Currently unhoused without a primary address
* Life threatening or unstable condition requiring treatment (e.g., suicidal/homicidal ideation)

Primary outcomes:
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Urine Drug Screens (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Client Urine Drug Screens (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Client Abstinence Self Efficacy (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Levels of services Emerging Adult Client Satisfaction with Treatment (measured at 4 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Client Vocational and Educational Attainment (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Client Quality of Relationship with Paraprofessional Coach (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Recovery Capital (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use and Problems (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Criminal Legal System Involvement (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Service Utilization (measured at 0, 4, and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Arrests.
timeFrame: From client's 18th birthday to 6 months post-baseline
measure: Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Charges.
timeFrame: From client's 18th birthday to 6 months post-baseline
measure: Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Convictions.
timeFrame: From client's 18th birthday to 6 months post-baseline
measure: Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Incarcerations.
timeFrame: Client's 18th birthday to 6 months
measure: Attitudes at 6 months post-baseline in Emerging Adult Client Attitudes Toward the Services Provided (measured at 6 months).
timeFrame: 6 months
measure: Changes from baseline to 6 months in Emerging Adult Client Session Attendance and Vocational/Educational Activity Completion (measured at 1, 2, 3, 4, 5, and 6 months).
timeFrame: Baseline to 6 months
measure: Rates of post-services Services Completion.
timeFrame: Post-services, an average of 6 months
measure: Changes from baseline to up to 30 months post-baseline in Paraprofessional Coach Abstinence Self Efficacy (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline to up to 30 months post-baseline in Paraprofessional Coach Attitudes Toward Medications for Opioid Use Disorder (MOUD) (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from Baseline scores compared to up to 30 months post-baseline in Paraprofessional Coach Contingency Management (CM) Adherence (measured monthly for 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Client Vocational and Educational Attainment (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Recovery Capital (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Substance Use and Problems (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Perceptions of Acceptability of the PEERS Intervention (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Perceptions of PEERS Intervention Appropriateness (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Perceptions of Feasibility of the PEERS Intervention (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Quality of Life (measured at 0, 6, 12, 18, 24, and 30 months).
timeFrame: Baseline to 30 months
measure: Changes from post-training to post-service delivery on attitudes towards the training, supervision, and implementation of the services delivery (measured at approximately 1, 6, and 12 months).
timeFrame: Post-training, an average of one month, to post-service delivery of two more clients, an average of one year
measure: Differences in themes derived from 60 audio-recorded sessions tapes varied across paraprofessional coaches, emerging adult clients, session number, and project timeline from Paraprofessional Coaches With and Without Lived Experience (measured monthly).
timeFrame: Across Services Delivery, an average of 6 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Chestnut Health Systems
state: Oregon
Study officials:
References: