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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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;

Condition or disease Intervention/treatment Phase
Psychotic Disorders Substance Use Behavioral: Invest in My Recovery Bank Behavioral: Usual Care Peer Services Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
Official Title: Advancing the Early Psychosis Intervention Network in Texas
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 32 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517279


Contacts
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Contact: Molly Lopez, PhD 5125600484 mlopez@austin.utexas.edu
Contact: Deborah Cohen, PhD 512-232-0618 dacohen@austin.utexas.edu

Sponsors and Collaborators
University of Texas at Austin
Southern Methodist University
Thresholds Inc.
Indiana University
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Responsible Party: Molly Lopez, Research Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04517279    
Other Study ID Numbers: 1R01MH120599 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molly Lopez, University of Texas at Austin:
early psychosis
cannabis use
alcohol use
substance use
Additional relevant MeSH terms:
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Substance-Related Disorders
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders