NCT04517279|CompletedDMC
Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention
PAS-EPP
Advancing the Early Psychosis Intervention Network in Texas
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PAS-EPP
Advancing the Early Psychosis Intervention Network in Texas
Sponsor study identifier
NIH
interventional
113
1 country
15
Study Start
August 22, 2023
Actual (reported)Primary Completion
July 25, 2025
Actual (reported)Study Completion
July 25, 2025
Actual (reported)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;
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 25, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2020
Actual (reported)August 18, 2020
Actual (reported)August 22, 2023
Actual (reported)July 25, 2025
Actual (reported)July 25, 2025
Actual (reported)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
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
Participant qualitative feedback
12 months after initiation of the intervention.
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
The peer providers operating under the Usual Care condition will continue to provide peer support services to individuals within the coordinated specialty care team.
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.
Integral Care
Austin, Texas, 78702, United States
Spindletop Centers
Beaumont, Texas, 77701, United States
West Texas Centers
Big Spring, Texas, 79720, United States
Metrocare Services
Dallas, Texas, 75208, United States
Denton County MHMR
Denton, Texas, 76201, United States
The Harris Center for Mental Health and IDD
Houston, Texas, 77074, United States
Border Region Behavioral Health Center
Laredo, Texas, 78041, United States
113 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2020
First Posted
August 18, 2020
Study Start
August 22, 2023
Actual (reported)Psychosis TMS Study
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Community Healthcore
Longview, Texas, 75601, United States
Burke
Lufkin, Texas, 75901, United States
Coastal Plains
Portland, Texas, 78374, United States
Bluebonnet Trails Community Center
Round Rock, Texas, 78664, United States
Center for Healthcare Services
San Antonio, Texas, 78213, United States
Central Counties Services
Temple, Texas, 76501, United States
Andrews Behavioral Health
Tyler, Texas, 75702, United States
Pecan Valley Centers
Weatherford, Texas, 76086, United States
Primary Completion
July 25, 2025
Actual (reported)Study Completion
July 25, 2025
Actual (reported)Last Updated
December 19, 2025
Record last verified: 2025-12
Yes, data from this study will be submitted to the NIMH National Data Archive, along with appropriate data documentation.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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