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Completed

NCT Number: NCT04517279

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

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;

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Key information

Conditions

Psychotic Disorders Alcohol Drinking Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance Use Substance-Related Disorders

Age range

15 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integral Care, Austin, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Alcohol Use

    Time frame: 6 months after initiation of the intervention

    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.

  2. Alcohol Use

    Time frame: 12 months after initiation of the intervention

    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.

  3. Drug Use

    Time frame: 6 months after initiation of the intervention

    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.

  4. Drug Use

    Time frame: 12 months after initiation of the intervention

    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.

  5. Role Functioning

    Time frame: 6 months after initiation of the intervention

    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. Role Functioning

    Time frame: 12 months after initiation of the intervention

    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.

  7. Social Functioning

    Time frame: 6 months after initiation of the intervention

    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.

  8. Social Functioning

    Time frame: 12 months after initiation of the intervention

    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.

Secondary outcomes

  1. Stage of Change

    Time frame: 6 months after initiation of the intervention

    This secondary outcome is measured on the Substance Abuse Treatment Scale. The scale is ordinal, with 1 reflecting the "pre-engagement" stage and 7 reflecting "relapse prevention." Higher numbers reflect a more advanced stage of substance use treatment.

  2. Stage of Change

    Time frame: 12 months after initiation of the intervention

    This secondary outcome is measured on the Substance Abuse Treatment Scale. The scale is ordinal, with 1 reflecting the "pre-engagement" stage and 7 reflecting "relapse prevention." Higher numbers reflect a more advanced stage of substance use treatment.

  3. Perceived Well-being

    Time frame: 6 months after initiation of the intervention

    This secondary outcome is measured by the Personal Well-being Inventory. The summary score ranges from 0 to 100, with higher scores reflecting greater subjective well-being.

  4. Perceived Well-being

    Time frame: 12 months after initiation of the intervention

    This secondary outcome is measured by the Personal Well-being Inventory. The summary score ranges from 0 to 100, with higher scores reflecting greater subjective well-being.

  5. Recovery

    Time frame: 6 months after initiation of the intervention

    This secondary outcome is measured by the Questionnaire about the Process of Recovery. The total score ranges from 0 to 60, with higher scores reflecting greater recovery.

  6. Recovery

    Time frame: 12 months after initiation of the intervention

    This secondary outcome is measured by the Questionnaire about the Process of Recovery. The total score ranges from 0 to 60, with higher scores reflecting greater recovery.

  7. Severity of Psychiatric Symptomatology

    Time frame: 6 months after initiation of the intervention.

    This secondary outcome is measured by the Brief Psychiatric Rating Scale. The total score ranges from 0 to 108, with higher scores reflecting greater severity.

  8. Severity of Psychiatric Symptomatology

    Time frame: 12 months after initiation of the intervention.

    This secondary outcome is measured by the Brief Psychiatric Rating Scale. The total score ranges from 0 to 108, with higher scores reflecting greater severity.

Other outcomes

  1. Participant qualitative feedback

    Time frame: 12 months after initiation of the intervention.

    Some participants will participate in qualitative interviews on acceptability of the intervention.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Indiana University
  • Southern Methodist University
  • University of Texas Southwestern Medical Center

Registry information

Official study title

Advancing the Early Psychosis Intervention Network in Texas

Acronym: PAS-EPP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2020
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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