Clinical trial NCT04517279: Peer Approaches to Substances in Early Psychosis Programs: A Pilot Study of a Peer-Led Intervention
Official title: Advancing the Early Psychosis Intervention Network in Texas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Substance Use
Keywords: early psychosis
cannabis use
alcohol use
substance use
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Southern Methodist University
name: Thresholds Inc.
name: Indiana University
First posted: 2020-08-18
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The model is a cluster randomized controlled trial with randomization at the team level.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alcohol Use
timeFrame: 6 months after initiation of the intervention
measure: Alcohol Use
timeFrame: 12 months after initiation of the intervention
measure: Drug Use
timeFrame: 6 months after initiation of the intervention
measure: Drug Use
timeFrame: 12 months after initiation of the intervention
measure: Role Functioning
timeFrame: 6 months after initiation of the intervention
measure: Role Functioning
timeFrame: 12 months after initiation of the intervention
measure: Social Functioning
timeFrame: 6 months after initiation of the intervention
measure: Social Functioning
timeFrame: 12 months after initiation of the intervention
Secondary outcomes:
measure: Stage of Change
timeFrame: 6 months after initiation of the intervention
measure: Stage of Change
timeFrame: 12 months after initiation of the intervention
measure: Perceived Well-being
timeFrame: 6 months after initiation of the intervention
measure: Perceived Well-being
timeFrame: 12 months after initiation of the intervention
measure: Recovery
timeFrame: 6 months after initiation of the intervention
measure: Recovery
timeFrame: 12 months after initiation of the intervention
measure: Severity of Psychiatric Symptomatology
timeFrame: 6 months after initiation of the intervention.
measure: Severity of Psychiatric Symptomatology
timeFrame: 12 months after initiation of the intervention.
Other outcomes:
measure: Participant qualitative feedback
timeFrame: 12 months after initiation of the intervention.
Locations:
Study officials:
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