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

Primary Purpose

Psychotic Disorders, Substance Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Invest in My Recovery Bank
Usual Care Peer Services
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring early psychosis, cannabis use, alcohol use, substance use

Eligibility Criteria

15 Years - 32 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Peer Approaches to Substances in Early Psychosis Programs

    Usual Care

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Stage of Change
    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.
    Stage of Change
    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.
    Perceived Well-being
    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.
    Perceived Well-being
    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.
    Recovery
    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.
    Recovery
    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.
    Severity of Psychiatric Symptomatology
    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.
    Severity of Psychiatric Symptomatology
    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.

    Full Information

    First Posted
    August 12, 2020
    Last Updated
    July 14, 2023
    Sponsor
    University of Texas at Austin
    Collaborators
    Southern Methodist University, Thresholds Inc., Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04517279
    Brief Title
    Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention
    Acronym
    PAS-EPP
    Official Title
    Advancing the Early Psychosis Intervention Network in Texas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    January 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas at Austin
    Collaborators
    Southern Methodist University, Thresholds Inc., Indiana University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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;
    Detailed Description
    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 multi-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 twice 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychotic Disorders, Substance Use
    Keywords
    early psychosis, cannabis use, alcohol use, substance use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The model is a cluster randomized controlled trial with randomization at the team level.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Peer Approaches to Substances in Early Psychosis Programs
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    The peer providers operating under the Usual Care condition will continue to provide peer support services to individuals within the coordinated specialty care team.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Invest in My Recovery Bank
    Intervention Description
    The intervention has not be fully developed. It will be created in partnership with individuals serving in peer provider roles.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care Peer Services
    Intervention Description
    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 Outcome Measure Information:
    Title
    Alcohol Use
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Alcohol Use
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Title
    Drug Use
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Drug Use
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Title
    Role Functioning
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Role Functioning
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Title
    Social Functioning
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Social Functioning
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Secondary Outcome Measure Information:
    Title
    Stage of Change
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Stage of Change
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Title
    Perceived Well-being
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Perceived Well-being
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Title
    Recovery
    Description
    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.
    Time Frame
    6 months after initiation of the intervention
    Title
    Recovery
    Description
    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.
    Time Frame
    12 months after initiation of the intervention
    Title
    Severity of Psychiatric Symptomatology
    Description
    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.
    Time Frame
    6 months after initiation of the intervention.
    Title
    Severity of Psychiatric Symptomatology
    Description
    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.
    Time Frame
    12 months after initiation of the intervention.
    Other Pre-specified Outcome Measures:
    Title
    Participant qualitative feedback
    Description
    Some participants will participate in qualitative interviews on acceptability of the intervention.
    Time Frame
    12 months after initiation of the intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    32 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Molly Lopez, PhD
    Phone
    5125600484
    Email
    mlopez@austin.utexas.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Deborah Cohen, PhD
    Phone
    512-232-0618
    Email
    dacohen@austin.utexas.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Individual data on participants will be shared through a national data coordinated center as a component of the EPINET initiative.

    Learn more about this trial

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

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