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

Psychotic Disorders Clinical Trial

— PAS-EPP  

Official title:

Advancing the Early Psychosis Intervention Network in Texas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04517279
• Other study ID #: 1R01MH120599
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: University of Texas at Austin
• Contact: Molly Lopez, PhD
• Phone: 5125600484
• Email: mlopez[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 31, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 32 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Substance Use
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Texas at Austin	Indiana University, Southern Methodist University, Thresholds Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant qualitative feedback	Some participants will participate in qualitative interviews on acceptability of the intervention.	12 months after initiation of the intervention.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.