Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Feasibility of intervention- recruitment rate
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 12 Years to 22 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Previously met diagnostic criteria for full psychosis on the Structured Interview for Psychosis Risk Syndromes.
- •Does not meet inclusion criteria listed above.
Arms & Interventions
InVEST
4 month treatment condition
Intervention: InVEST (Behavioral)
delayed invest
participants in delayed invest wait four months and are reassessed before taking part in the intervention
Outcomes
Primary Outcomes
Feasibility of intervention- recruitment rate
Time Frame: baseline
recruitment rates
Feasibility of intervention- drop out
Time Frame: 4 months
drop outs
Feasibility of intervention -Client Satisfaction
Time Frame: 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)
Secondary Outcomes
- Role functioning(change from baseline to 4 months and baseline to 8 months)
Investigators
Michelle Friedman-Yakobian
Assistant Professor
Beth Israel Deaconess Medical Center