Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Feasibility of intervention- recruitment rate
研究概览
简要总结
The purpose of this study is to test the efficacy of InVEST (Individualized Vocational and Educational Support and Training) for CHR-P (clinical high risk for psychosis) to address specific role functioning difficulties associated with the CHR-P phase. Our specific goals are:
- Part 1: Preliminary open trial of InVEST (n = 8) to collect preliminary feasibility and acceptability data by providing the intervention, administering assessments, and collecting focus group and self-report feedback from open trial participants. The open trial phase will help to refine recruitment approaches and to modify the treatment manual as needed.
- Part 2: Preliminary randomized controlled trial of InVEST vs. Delayed InVEST (DI) to explore preliminary evidence of efficacy of InVEST vs. DI (n = 30). The investigators hope to gain understanding of the feasibility of InVEST and the study's assessment procedures, and to gain a preliminary understanding of the intervention's efficacy for functioning difficulties experienced by young people at CHR-P.
详细描述
InVEST is a novel intervention that aims to target three clusters of mechanisms believed to be key in contributing to increasing functional impairment in CHR-P: 1) executive functioning (a cognitive mechanism), 2) increased stress sensitivity (an emotional mechanism), and 3) task initiation difficulties (a behavioral mechanism). Conceptually, these mechanisms are consistent with a CBT conceptualization of role functioning impairment, and the strategies to target each mechanism will be adapted based on existing evidence-based interventions combined with clinical expertise in CHR-P treatment. Finally, our proposed project is based on robust scientific evidence supporting the need for early intervention, targeting functional impairment and related risk factors in individuals at CHR-P.
This study will be organized in two parts:
Part 1: Manual development and a preliminary open-trial (n = 8) to guide the development and refinement of InVEST through coach experiences and study participant feedback. Participants will complete the intervention and then a post-intervention focus group, providing data on the feasibility of InVEST and to direct the development of the InVEST intervention manual.
Part 2: A small, randomized trial comparing InVEST treatment (2 groups, n = 15 each). Participants will be randomized using a delayed treatment design, with half of participants randomized into InVEST and half randomized into a 4-month Delayed InVEST (DI; 4 month wait to start). Primary outcome measures will include CHR-P symptoms; global role functioning; executive functioning; stress sensitivity; task initiation; hopelessness; and suicidality.
Overview of Intervention: InVEST for CHR-P
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
- Single (Outcomes Assessor)
盲法说明
part 1 is open label design. Next part is RCT waiting list control design. assessors will be unaware of whether the participant was in the waiting list condition or the active condition.
入排标准
- 年龄范围
- 12 Years 至 22 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •can speak English,
- •meet broad CHR-P criteria based on the Structured Interview for Psychosis Risk Syndromes (SIPS),
- •shows at least mild role functioning impairment on the Global Functioning-Role scale (GF:R),
- •parent is willing to provide permission (and client is willing to assent) for invest coaches to communicate with treatment providers.
排除标准
- •Previously met diagnostic criteria for full psychosis on the Structured Interview for Psychosis Risk Syndromes.
- •Does not meet inclusion criteria listed above.
研究组 & 干预措施
InVEST
4 month treatment condition
干预措施: InVEST (Behavioral)
delayed invest
participants in delayed invest wait four months and are reassessed before taking part in the intervention
结局指标
主要结局
Feasibility of intervention- recruitment rate
时间窗: baseline
recruitment rates
Feasibility of intervention- drop out
时间窗: 4 months
drop outs
Feasibility of intervention -Client Satisfaction
时间窗: 4 months
Attkisson Client Satisfaction Questionnaire is a seven item scale measuring an individual's personal experience with a service (range 7-28 with higher scores indicating greater level of satisfaction)
次要结局
- Role functioning(change from baseline to 4 months and baseline to 8 months)
研究者
Michelle Friedman-Yakobian
Assistant Professor
Beth Israel Deaconess Medical Center
