Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)

NCT05114733 | Completed

• 1 other identifier: 2021P000689
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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:

1. 1.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.
2. 2.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.

Conditions

Clinical High Risk for Psychosis

Keywords

clinical high risk for psychosis; psychosis risk syndrome; school functioning; intervention

Outcome Measures

Primary Outcomes (3)

• Feasibility of intervention- recruitment rate

  recruitment rates

  baseline

• Feasibility of intervention -Client Satisfaction

  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)

  4 months

• Feasibility of intervention- drop out

  drop outs

  4 months

Secondary Outcomes (1)

• Role functioning

  change from baseline to 4 months and baseline to 8 months

Study Arms (2)

InVEST

EXPERIMENTAL

4 month treatment condition

Behavioral: InVEST

delayed invest

NO INTERVENTION

participants in delayed invest wait four months and are reassessed before taking part in the intervention

Interventions

InVEST BEHAVIORAL

Individualized vocational and educational support and training -- participant works with BA level school/ work coach for four months

InVEST

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 12-22,
• 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.

You may not qualify if:

• Previously met diagnostic criteria for full psychosis on the Structured Interview for Psychosis Risk Syndromes.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center/ Massachusetts Mental Health Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• West ML, Parrish EM, Friedman-Yakoobian M. Treatment outcomes for young people at clinical high risk for psychosis: Data from a specialized clinic. Early Interv Psychiatry. 2022 May;16(5):500-508. doi: 10.1111/eip.13187. Epub 2021 Jul 26.

  PMID: 34309198 BACKGROUND

• West ML, Parrish EM, Green J, Howland C, Friedman-Yakoobian M. Individualized vocational and educational support and training for youth at clinical high risk for psychosis. Early Interv Psychiatry. 2022 May;16(5):492-499. doi: 10.1111/eip.13186. Epub 2021 Jul 26.

  PMID: 34309187 RESULT

Study Officials

• Michelle Friedman-Yakoobian, PHD

  Department of Psychiatry at BIDMC - a major teaching hospital of Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: waitlist control design

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 10, 2021
• Study Start: February 22, 2022
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)