Psychotic DisordersPAS-EPPNCT04517279
Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention
A study testing Peer Approach to Substances in Early Psychosis Programs in people with Psychotic Disorders and Substance Use, run by University of Texas at Austin at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 32 years
- Conditions the study is for
- Psychotic Disorders, Substance Use
- What is being tested?
- Peer Approach to Substances in Early Psychosis Programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 15 sitesUnited States
- Study dates
- 22 Aug 2023to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 32 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Integral Care
Austin, Texas, 78702
Spindletop Centers
Beaumont, Texas, 77701
West Texas Centers
Big Spring, Texas, 79720
Metrocare Services
Dallas, Texas, 75208
Denton County MHMR
Denton, Texas, 76201
The Harris Center for Mental Health and IDD
Houston, Texas, 77074
Border Region Behavioral Health Center
Laredo, Texas, 78041
Community Healthcore
Longview, Texas, 75601
Burke
Lufkin, Texas, 75901
Coastal Plains
Portland, Texas, 78374
Bluebonnet Trails Community Center
Round Rock, Texas, 78664
Center for Healthcare Services
San Antonio, Texas, 78213
Central Counties Services
Temple, Texas, 76501
Andrews Behavioral Health
Tyler, Texas, 75702
Pecan Valley Centers
Weatherford, Texas, 76086
About this study
Official title: 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;
Read the 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 one-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 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.
- Conditions
- Psychotic Disorders, Substance Use
- Being tested
- Peer Approach to Substances in Early Psychosis Programs, Usual Care Peer Services
- Keywords
- early psychosis, cannabis use, alcohol use, substance use
- Medical subject headings
- Psychotic Disorders, Substance-Related Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Approach to Substances in Early Psychosis ProgramsBehavioural
The intervention is consists of four core practice domains. Domain one includes practices that explore a young person's perspective, experience and beliefs around substances, validate through sharing personal experiences, and connect the young person with information around substances to inform decision-making. Domain two includes activities that support goals around substance use, including exploring motivation to change, identifying available supports, and planning to reduce negative effects of substance use. Domain three includes strategies to build recovery capital, such as enhanced social support. Domain four includes advocacy strategies within the CSC team to support client engagement and team coordination.
Usual Care Peer ServicesBehavioural
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 group | Role | What they receive |
|---|---|---|
| Peer Approaches to Substances in Early Psychosis Programs | Experimental | 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 Receives: Behavioral: Peer Approach to Substances in Early Psychosis Programs |
| Usual Care | Active comparator | The peer providers operating under the Usual Care condition will continue to provide peer support services to individuals within the coordinated specialty care team. Receives: Behavioral: Usual Care Peer Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after initiation of the intervention
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after initiation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start22 Aug 2023
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The model is a cluster randomized controlled trial with randomization at the team level.
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Methodist University, Indiana University, University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, Molly Lopez, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517279
- Sponsor's protocol ID
- 1R01MH120599
- Acronym
- PAS-EPP
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2020
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, data from this study will be submitted to the NIMH National Data Archive, along with appropriate data documentation.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Early Psychosis Intervention Network in Texas
- ClinicalTrials.gov ID
- NCT04517279
- Acronym / sponsor ID
- PAS-EPP / 1R01MH120599
- Conditions
- Psychotic Disorders, Substance Use
- Keywords
- early psychosis, cannabis use, alcohol use, substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Southern Methodist University, Indiana University, University of Texas Southwestern Medical Center
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 one-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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The model is a cluster randomized controlled trial with randomization at the team level.
| Arm | Type | Receives |
|---|---|---|
| Peer Approaches to Substances in Early Psychosis Programs | Experimental | Behavioral: Peer Approach to Substances in Early Psychosis ProgramsThe 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 |
| Usual Care | Active comparator | Behavioral: Usual Care Peer ServicesThe peer providers operating under the Usual Care condition will continue to provide peer support services to individuals within the coordinated specialty care team. |
Who may qualify
- Ages
- 15 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Approach to Substances in Early Psychosis ProgramsThe intervention is consists of four core practice domains. Domain one includes practices that explore a young person's perspective, experience and beliefs around substances, validate through sharing personal experiences, and connect the young person with information around substances to inform decision-making. Domain two includes activities that support goals around substance use, including exploring motivation to change, identifying available supports, and planning to reduce negative effects of substance use. Domain three includes strategies to build recovery capital, such as enhanced social support. Domain four includes advocacy strategies within the CSC team to support client engagement and team coordination. | Behavioural | Peer Approaches to Substances in Early Psychosis Programs |
| Usual Care Peer ServicesUsual 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. | Behavioural | Usual Care |
Primary outcome
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.
8 secondary outcomes
Stage of Change
Time frame: 6 months after initiation of the intervention
Stage of Change
Time frame: 12 months after initiation of the intervention
Perceived Well-being
Time frame: 6 months after initiation of the intervention
Perceived Well-being
Time frame: 12 months after initiation of the intervention
Recovery
Time frame: 6 months after initiation of the intervention
Recovery
Time frame: 12 months after initiation of the intervention
Severity of Psychiatric Symptomatology
Time frame: 6 months after initiation of the intervention.
Severity of Psychiatric Symptomatology
Time frame: 12 months after initiation of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. Yes, data from this study will be submitted to the NIMH National Data Archive, along with appropriate data documentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Approach to Substances in Early Psychosis Programs in people with Psychotic Disorders and Substance Use, run by University of Texas at Austin at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (time frame: 6 months after initiation of the intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.