Reducing Drug Use in Justice-Involved Emerging Adults

Substance-Related Disorders Clinical Trial

— PEERS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834881
• Other study ID #: K23DA048161
• Secondary ID: K23DA048161
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: Chestnut Health Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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 at least 6 months remaining on their parole and probation sentence
• 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)

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• Contingency Management (CM) combined with vocational/educational coaching
Two evidence based practices, CM and vocational/educational coaching, will be combined and delivered by paraprofessional coaches in an intervention named PEERS (Peers Education Empowering Recovery Supports). CM uses positive reinforcement (e.g., chances to win prizes) for clients who abstain from substance use. A standardized and well-validated CM protocol will be used in the proposed study. Vocational/educational coaching assists individuals in completing educational and vocational goals. A workbook developed specifically for vocational/educational coaching in emerging adults will be used in the study.

Locations

Country	Name	City	State
United States	Chestnut Health Systems	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Chestnut Health Systems	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Number of positive drug screens from toxicology testing with paraprofessional coaches for amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, fentanyl, methamphetamines, methylenedioxymethamphetamine (MDMA), methadone, oxycodone, phencyclidine (PCP), tetrahydrocannabinol (THC), and alcohol (ETG).	Baseline to 30 months
Primary	Changes from baseline to 6 months post-baseline in Emerging Adult Client Urine Drug Screens (measured at 0, 4, and 6 months).	Number of positive drug screens from toxicology testing with paraprofessional coaches for amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, fentanyl, methamphetamines, methylenedioxymethamphetamine (MDMA), methadone, oxycodone, phencyclidine (PCP), tetrahydrocannabinol (THC), and alcohol (ETG).	Baseline to 6 months
Secondary	Changes from baseline to 6 months post-baseline in Emerging Adult Client Abstinence Self Efficacy (measured at 0, 4, and 6 months).	Levels of abstinence self-efficacy reported by emerging adult clients on the Abstinence Self Efficacy Scale.	Baseline to 6 months
Secondary	Levels of services Emerging Adult Client Satisfaction with Treatment (measured at 4 and 6 months).	Levels of satisfaction with the coaches' services reported by emerging adult clients on the Client Satisfaction Questionnaire.	Baseline to 6 months
Secondary	Changes from baseline to 6 months post-baseline in Emerging Adult Client Vocational and Educational Attainment (measured at 0, 4, and 6 months).	Advancement of vocational and educational attainment reported by emerging adult clients on the modified JCOIN Core Measures Demographics.	Baseline to 6 months
Secondary	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).	Levels of the quality of the relationship between the emerging adult client and the paraprofessional coach as reported by emerging adult clients on the Dual Role Relationship Inventory.	Baseline to 6 months
Secondary	Changes from baseline to 6 months post-baseline in Emerging Adult Recovery Capital (measured at 0, 4, and 6 months).	Levels of recovery capital as reported by emerging adult clients on the Emerging Adult Recovery Capital Scale.	Baseline to 6 months
Secondary	Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use and Problems (measured at 0, 4, and 6 months).	Frequency of substance use and substance-related problems reported by emerging adult clients on the Global Appraisal of Individual Needs.	Baseline to 6 months
Secondary	Changes from baseline to 6 months post-baseline in Emerging Adult Criminal Legal System Involvement (measured at 0, 4, and 6 months).	Frequency of criminal legal system involvement reported by emerging adult clients on the Justice Community Opioid Innovation Network (JCOIN) Core Measures Justice Involvement Scale.	Baseline to 6 months
Secondary	Changes from baseline to 6 months post-baseline in Emerging Adult Service Utilization (measured at 0, 4, and 6 months).	Frequency of service utilization reported by emerging adult clients on the JCOIN Core Measures Service Utilization Scale.	Baseline to 6 months
Secondary	Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Arrests.	Number of emerging adult client arrests before and during service engagement measured via official arrest records.	From client's 18th birthday to 6 months post-baseline
Secondary	Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Charges.	Number of emerging adult client charges before and during service engagement measured via official arrest records.	From client's 18th birthday to 6 months post-baseline
Secondary	Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Convictions.	Number of emerging adult client convictions before and during service engagement measured via official arrest records.	From client's 18th birthday to 6 months post-baseline
Secondary	Changes from client's 18th birthday to 6 months post-baseline in Emerging Adult Client Incarcerations.	Number of emerging adult client incarcerations before and during service engagement measured via official arrest records.	Client's 18th birthday to 6 months
Secondary	Attitudes at 6 months post-baseline in Emerging Adult Client Attitudes Toward the Services Provided (measured at 6 months).	Emerging adult attitudes toward the services program as measured during qualitative interviews with emerging adult clients.	6 months
Secondary	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).	Frequency of emerging adult attendance at their paraprofessional coach sessions and completion of vocational/educational coaching activities reported by paraprofessional coaches on the Session Checklist and session tape coding.	Baseline to 6 months
Secondary	Rates of post-services Services Completion.	Rates of emerging adult client services completion reported by paraprofessional coaches using the Services Termination Form.	Post-services, an average of 6 months
Secondary	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).	Levels of abstinence self-efficacy reported by paraprofessional coaches on the Abstinence Self Efficacy Scale.	Baseline to 30 months
Secondary	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).	Levels of attitudes toward MOUD reported by paraprofessional coaches on the JCOIN Core Measures Attitudes Toward MOUD Scale.	Baseline to 30 months
Secondary	Changes from Baseline scores compared to up to 30 months post-baseline in Paraprofessional Coach Contingency Management (CM) Adherence (measured monthly for 30 months).	Adherence to CM practices by paraprofessional coaches as measured using the CM-Therapist Adherence Measure (CM-TAM) (Self-report version and Tape Coding version).	Baseline to 30 months
Secondary	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).	Advancement of vocational and educational attainment reported by paraprofessional coaches on the modified JCOIN Core Measures Demographics.	Baseline to 30 months
Secondary	Changes from baseline up to 30 months post-baseline in Paraprofessional Coach Recovery Capital (measured at 0, 6, 12, 18, 24, and 30 months).	Levels of recovery capital as reported by paraprofessional coaches on the Emerging Adult Recovery Capital Scale.	Baseline to 30 months
Secondary	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).	Frequency of substance use and substance-related problems reported by paraprofessional coaches on the Global Appraisal of Individual Needs.	Baseline to 30 months
Secondary	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).	Levels of acceptability of the PEERS intervention, such as if participants like the intervention, as reported by paraprofessional coaches on the Acceptability of Intervention Measure (Weiner et al., 2017). Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability.	Baseline to 30 months
Secondary	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).	Levels of PEERS intervention appropriateness, such as if the intervention is a good match, as reported by paraprofessional coaches on the Intervention Appropriateness Measure (Weiner et al., 2017). Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness.	Baseline to 30 months
Secondary	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).	Levels of PEERS intervention feasibility, such as if the intervention is easy to use, as reported by paraprofessional coaches on the Feasibility of Intervention Measure (Weiner et al., 2017). Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility.	Baseline to 30 months
Secondary	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).	Levels of quality of life reported by paraprofessional coaches on the JCOIN Core Measures Quality of Life Scale from the Patient-Reported Outcomes Measurement Information System.	Baseline to 30 months
Secondary	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).	Ratings on attitudes towards the training, supervision, and implementation of the services delivery as measured by qualitative interviews with paraprofessional coaches.	Post-training, an average of one month, to post-service delivery of two more clients, an average of one year
Secondary	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).	Sixty tapes from audio-recorded sessions of paraprofessional coaches with their emerging adult clients will be coded to determine themes that arise in the course of sessions to compare themes used in sessions by paraprofessional coach with and without lived experience.	Across Services Delivery, an average of 6 months