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

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ClinicalTrials.gov Identifier: NCT04517279
Recruitment Status : Not yet recruiting
First Posted : August 18, 2020
Last Update Posted : July 18, 2023
Sponsor:
Collaborators:
Southern Methodist University
Thresholds Inc.
Indiana University
Information provided by (Responsible Party):
Molly Lopez, University of Texas at Austin

Tracking Information
First Submitted Date  ICMJE August 12, 2020
First Posted Date  ICMJE August 18, 2020
Last Update Posted Date July 18, 2023
Estimated Study Start Date  ICMJE August 1, 2023
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2020)
Participant qualitative feedback [ Time Frame: 12 months after initiation of the intervention. ]
Some participants will participate in qualitative interviews on acceptability of the intervention.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention
Official Title  ICMJE Advancing the Early Psychosis Intervention Network in Texas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The model is a cluster randomized controlled trial with randomization at the team level.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Psychotic Disorders
  • Substance Use
Intervention  ICMJE
  • Behavioral: Invest in My Recovery Bank
    The intervention has not be fully developed. It will be created in partnership with individuals serving in peer provider roles.
  • 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.
Study Arms  ICMJE
  • Experimental: Peer Approaches to Substances in Early Psychosis Programs
    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
    Intervention: Behavioral: Invest in My Recovery Bank
  • Active Comparator: Usual Care
    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: Behavioral: Usual Care Peer Services
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2020)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2025
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 32 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Molly Lopez, PhD 5125600484 mlopez@austin.utexas.edu
Contact: Deborah Cohen, PhD 512-232-0618 dacohen@austin.utexas.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04517279
Other Study ID Numbers  ICMJE 1R01MH120599( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Individual data on participants will be shared through a national data coordinated center as a component of the EPINET initiative.
Current Responsible Party Molly Lopez, University of Texas at Austin
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas at Austin
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Southern Methodist University
  • Thresholds Inc.
  • Indiana University
Investigators  ICMJE Not Provided
PRS Account University of Texas at Austin
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP