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
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
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
NCT ID
NCT04517279
First Posted
August 12, 2020
Last Updated
July 14, 2023
Sponsor
University of Texas at Austin
Collaborators
Southern Methodist University, Thresholds Inc., Indiana University
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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