Advancing the Early Psychosis Intervention Network in Texas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 30
- 主要终点
- Alcohol Use
研究概览
简要总结
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;
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 32 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Alcohol Use
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Stage of Change(12 months after initiation of the intervention)
- Perceived Well-being(12 months after initiation of the intervention)
- Recovery(12 months after initiation of the intervention)
- Severity of Psychiatric Symptomatology(12 months after initiation of the intervention.)
研究者
Molly Lopez
Research Associate Professor
University of Texas at Austin