Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention

NCT ID: NCT04517279

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2025-07-25

Brief Summary

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The aim of the study is to pilot a peer-provided, manualized intervention to increase the proportion of young people with first episode psychosis who reduce or stop substance use and improve psychiatric and functional outcomes. Coordinated specialty care teams will be randomly assigned to implement the intervention, Peer Approaches to Substances in Early Psychosis Programs (PAS-EPP), or usual care. The pilot study aims to: (a) determine if peer providers can implement PAS-EPP with adequate fidelity; (b) determine if youth and young adults engage in the intervention with peer providers and find it acceptable; (c) estimate the rates of drop-out for each of the two study arms; (d) estimate both between-participant (within-provider team) and between-team variability on key outcome measures; and (e) identify any changes needed to the intervention approach, manual, or training materials. The pilot study will set the stage for a future comparative cluster randomized trial of the intervention;

Detailed Description

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The pilot study examines the feasibility of a cluster randomized controlled trial to measure the effectiveness of Peer Approaches to Substances in Early Psychosis Programs (PAS-EPP) compared to usual care (UC). PAS-EPP is a peer-led, manualized intervention to support youth and young adults receiving treatment for early psychosis with reducing or stopping problematic substance use. Peer providers, who represent clusters of service participants, will participate in a one-day PAS-EPP training. Training will include exploring the theoretical basis for the intervention approach and logic model, impact of service participant and peer provider on intervention design, the intervention strategies, and opportunities to build skill in each intervention component (e.g., role play with feedback). Peer providers will also receive monthly supervision to support intervention fidelity and resolve questions.

The proposed pilot study aims to: (a) determine if peer providers can implement PAS-EPP with adequate fidelity; (b) determine if youth and young adults engage in the intervention with peer providers and find it acceptable; (c) estimate the rates of drop-out for each of the two study arms; (d) estimate both between-participant (within-provider team) and between-team variability (e.g., standard deviation, interquartile range) on key outcome measures for a future comparative cluster randomized trial of the intervention; and (e) identify any changes needed to the intervention approach, manual, or training materials.

Twenty-five teams across 15 sites will be randomly assigned to PAS-EPP or UC, ensuring that the three sites with more than one team have at least one team randomized to each arm. All youth meeting eligibility criteria will be enrolled in the study and will receive either PAS-EPP or UC, based on the assignment status of their provider team. Intervention integrity will be measured through a peer-completed fidelity checklist. Participant outcomes will be measured through existing data collection at each participating organization. All participant outcome and service data is reported through the EPINET-TX platform, which allows for measurement-based care at participating sites and research using de-identified data.

Conditions

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Substance Use Psychotic Disorders

Keywords

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early psychosis cannabis use alcohol use substance use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The model is a cluster randomized controlled trial with randomization at the team level.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peer Approaches to Substances in Early Psychosis Programs

The Peer Approaches to Substances in Early Psychosis Programs arm is an intervention focused on enhancing the recovery capital of individuals in early psychosis care. The intervention is provided by a peer provider, operating on the coordinated specialty care team

Group Type EXPERIMENTAL

Peer Approach to Substances in Early Psychosis Programs

Intervention Type BEHAVIORAL

The intervention is consists of four core practice domains. Domain one includes practices that explore a young person's perspective, experience and beliefs around substances, validate through sharing personal experiences, and connect the young person with information around substances to inform decision-making. Domain two includes activities that support goals around substance use, including exploring motivation to change, identifying available supports, and planning to reduce negative effects of substance use. Domain three includes strategies to build recovery capital, such as enhanced social support. Domain four includes advocacy strategies within the CSC team to support client engagement and team coordination.

Usual Care

The peer providers operating under the Usual Care condition will continue to provide peer support services to individuals within the coordinated specialty care team.

Group Type ACTIVE_COMPARATOR

Usual Care Peer Services

Intervention Type BEHAVIORAL

Usual peer services involves supporting the process of change for individuals with mental health disorder to improve their health and wellness, live a self-directed life, and strive to reach their full potential.

Interventions

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Peer Approach to Substances in Early Psychosis Programs

The intervention is consists of four core practice domains. Domain one includes practices that explore a young person's perspective, experience and beliefs around substances, validate through sharing personal experiences, and connect the young person with information around substances to inform decision-making. Domain two includes activities that support goals around substance use, including exploring motivation to change, identifying available supports, and planning to reduce negative effects of substance use. Domain three includes strategies to build recovery capital, such as enhanced social support. Domain four includes advocacy strategies within the CSC team to support client engagement and team coordination.

Intervention Type BEHAVIORAL

Usual Care Peer Services

Usual peer services involves supporting the process of change for individuals with mental health disorder to improve their health and wellness, live a self-directed life, and strive to reach their full potential.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* enrolled in a CSC program during the defined study period;
* continued program enrollment at six month follow-up from program entry;
* continued alcohol/substance use at six-month follow-up from program entry.

Exclusion Criteria

* none
Minimum Eligible Age

15 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern Methodist University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Molly Lopez

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Integral Care

Austin, Texas, United States

Site Status

Spindletop Centers

Beaumont, Texas, United States

Site Status

West Texas Centers

Big Spring, Texas, United States

Site Status

Metrocare Services

Dallas, Texas, United States

Site Status

Denton County MHMR

Denton, Texas, United States

Site Status

The Harris Center for Mental Health and IDD

Houston, Texas, United States

Site Status

Border Region Behavioral Health Center

Laredo, Texas, United States

Site Status

Community Healthcore

Longview, Texas, United States

Site Status

Burke

Lufkin, Texas, United States

Site Status

Coastal Plains

Portland, Texas, United States

Site Status

Bluebonnet Trails Community Center

Round Rock, Texas, United States

Site Status

Center for Healthcare Services

San Antonio, Texas, United States

Site Status

Central Counties Services

Temple, Texas, United States

Site Status

Andrews Behavioral Health

Tyler, Texas, United States

Site Status

Pecan Valley Centers

Weatherford, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1R01MH120599

Identifier Type: NIH

Identifier Source: org_study_id

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