NCT05834881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

March 22, 2023

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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), alcohol (ETG), and morphine.

    Baseline to 30 months

  • 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 emerging adult clients for amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, fentanyl, methamphetamines, methylenedioxymethamphetamine (MDMA), methadone, oxycodone, phencyclidine (PCP), tetrahydrocannabinol (THC), alcohol (ETG) and morphine.

    Baseline to 6 months

Secondary Outcomes (27)

  • Changes from baseline to 6 months post-baseline in Emerging Adult Client Abstinence Self Efficacy (measured at 0, 4, and 6 months).

    Baseline to 6 months

  • Levels of services Emerging Adult Client Satisfaction with Treatment (measured at 4 and 6 months).

    Baseline to 6 months

  • Changes from baseline to 6 months post-baseline in Emerging Adult Client Vocational and Educational Attainment (measured at 0, 4, and 6 months).

    Baseline to 6 months

  • 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).

    Baseline to 6 months

  • Changes from baseline to 6 months post-baseline in Emerging Adult Recovery Capital (measured at 0, 4, and 6 months).

    Baseline to 6 months

  • +22 more secondary outcomes

Study Arms (2)

CM combined with Vocational/educational Coaching from Coaches without Lived Experience

EXPERIMENTAL

This group will receive contingency management (CM) combined with vocational/educational coaching from paraprofessional coaches without lived experience in community settings.

Behavioral: Contingency Management (CM) combined with vocational/educational coaching

CM combined with Vocational/educational Coaching from Coaches with Lived Experience

ACTIVE COMPARATOR

This group will receive contingency management (CM) combined with vocational/educational coaching from paraprofessional coaches with lived experience in community settings.

Behavioral: Contingency Management (CM) combined with vocational/educational coaching

Interventions

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.

CM combined with Vocational/educational Coaching from Coaches with Lived ExperienceCM combined with Vocational/educational Coaching from Coaches without Lived Experience

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18-30 years old

You may not qualify if:

  • Life threatening or unstable condition requiring treatment (e.g., suicidal/homicidal ideation)
  • Emerging Adult Client Eligibility Criteria
  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Health Systems

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 28, 2023

Study Start

May 26, 2023

Primary Completion

December 17, 2025

Study Completion

December 17, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations