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

NCT04517279 | Completed DMC

• 1 other identifier: 1R01MH120599
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 15

Brief Summary

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;

Conditions

Psychotic Disorders; Substance Use

Keywords

early psychosis; cannabis use; alcohol use; substance use

Outcome Measures

Primary Outcomes (8)

• Alcohol Use

  The primary outcome is the use of alcohol within the past 6 months as measured by the Alcohol Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Alcohol use is measured by a score of 2 or greater.

  6 months after initiation of the intervention

• Alcohol Use

  The primary outcome is the use of alcohol within the past 6 months as measured by the Alcohol Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Alcohol use is measured by a score of 2 or greater.

  12 months after initiation of the intervention

• Drug Use

  The primary outcome is the use of substances within the past 6 months as measured by the Drug Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Drug use is measured by a score of 2 or greater.

  6 months after initiation of the intervention

• Drug Use

  The primary outcome is the use of substances within the past 6 months as measured by the Drug Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Drug use is measured by a score of 2 or greater.

  12 months after initiation of the intervention

• Role Functioning

  The primary outcome is measured on the Global Functioning: Role scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.

  6 months after initiation of the intervention

• Role Functioning

  The primary outcome is measured on the Global Functioning: Role scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.

  12 months after initiation of the intervention

• Social Functioning

  The primary outcome is measured on the Global Functioning: Social scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.

  6 months after initiation of the intervention

• Social Functioning

  The primary outcome is measured on the Global Functioning: Social scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.

  12 months after initiation of the intervention

Secondary Outcomes (8)

• Stage of Change

  6 months after initiation of the intervention

• Stage of Change

  12 months after initiation of the intervention

• Perceived Well-being

  6 months after initiation of the intervention

• Perceived Well-being

  12 months after initiation of the intervention

• Recovery

  6 months after initiation of the intervention

Other Outcomes (1)

• Participant qualitative feedback

  12 months after initiation of the intervention.

Study Arms (2)

Peer Approaches to Substances in Early Psychosis Programs

EXPERIMENTAL

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

Behavioral: Peer Approach to Substances in Early Psychosis Programs

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care Peer Services

Interventions

Peer Approach to Substances in Early Psychosis Programs 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.

Peer Approaches to Substances in Early Psychosis Programs

Usual Care Peer Services 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.

Usual Care

Eligibility Criteria

• Age: 15 Years - 32 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Texas at Austin: lead
• Southern Methodist University: collaborator
• Indiana University: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (15)

Integral Care

Austin, Texas, 78702, United States

Location

Spindletop Centers

Beaumont, Texas, 77701, United States

Location

West Texas Centers

Big Spring, Texas, 79720, United States

Location

Metrocare Services

Dallas, Texas, 75208, United States

Location

Denton County MHMR

Denton, Texas, 76201, United States

Location

The Harris Center for Mental Health and IDD

Houston, Texas, 77074, United States

Location

Border Region Behavioral Health Center

Laredo, Texas, 78041, United States

Location

Community Healthcore

Longview, Texas, 75601, United States

Location

Burke

Lufkin, Texas, 75901, United States

Location

Coastal Plains

Portland, Texas, 78374, United States

Location

Bluebonnet Trails Community Center

Round Rock, Texas, 78664, United States

Location

Center for Healthcare Services

San Antonio, Texas, 78213, United States

Location

Central Counties Services

Temple, Texas, 76501, United States

Location

Andrews Behavioral Health

Tyler, Texas, 75702, United States

Location

Pecan Valley Centers

Weatherford, Texas, 76086, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Substance-Related Disorders; Alcohol Drinking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: The model is a cluster randomized controlled trial with randomization at the team level.

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: August 22, 2023
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data is estimated to be available by 8/31/2026.
• Access Criteria: The study data will be available to qualified researchers affiliated with an NIH-recognized institution through a request to the NIMH National Data Archive.

Locations

US (15)