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

Advancing the Early Psychosis Intervention Network in Texas

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;

Study Overview

• Status: Not yet recruiting
• Conditions: Psychotic Disorders; Substance Use
• Intervention / Treatment: Behavioral: Invest in My Recovery Bank; Behavioral: Usual Care Peer Services

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: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Molly Lopez, PhD; Phone Number: 5125600484; Email: mlopez@austin.utexas.edu
• Study Contact Backup: Name: Deborah Cohen, PhD; Phone Number: 512-232-0618; Email: dacohen@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 32 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention
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.	6 months after initiation of the intervention
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.	12 months after initiation of the intervention
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.	6 months after initiation of the intervention.
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.	12 months after initiation of the intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant qualitative feedback	Some participants will participate in qualitative interviews on acceptability of the intervention.	12 months after initiation of the intervention.

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Indiana University; Southern Methodist University; Thresholds Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: early psychosis; cannabis use; alcohol use; substance use
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 1R01MH120599 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual data on participants will be shared through a national data coordinated center as a component of the EPINET initiative.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No