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

NCT04517279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-12-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Southern Methodist University

    collaborator OTHER
  • Indiana University

    collaborator OTHER
  • University of Texas Southwestern Medical Center

    collaborator OTHER
  • University of Texas at Austin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
32 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2025-07-25
Completion
2025-07-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517279 on ClinicalTrials.gov