Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05114733
Recruitment Status : Not yet recruiting
First Posted : November 10, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Michelle Friedman-Yakobian, Beth Israel Deaconess Medical Center

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. 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. 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.

Condition or disease Intervention/treatment Phase
Clinical High Risk for Psychosis Behavioral: InVEST Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: waitlist control design
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.
Primary Purpose: Treatment
Official Title: Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: InVEST
4 month treatment condition
Behavioral: InVEST
Individualized vocational and educational support and training -- participant works with BA level school/ work coach for four months

No Intervention: delayed invest
participants in delayed invest wait four months and are reassessed before taking part in the intervention



Primary Outcome Measures :
  1. Feasibility of intervention- recruitment rate [ Time Frame: baseline ]
    recruitment rates

  2. 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)

  3. Feasibility of intervention- drop out [ Time Frame: 4 months ]
    drop outs


Secondary Outcome Measures :
  1. Role functioning [ Time Frame: change from baseline to 4 months and baseline to 8 months ]
    The global functioning role scale is a 10 point scale that rates school or work functioning. The scale ranges from 1-10, with 10 indicating the highest level of functioning.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. age 12-18,
  2. can speak English,
  3. meet broad CHR-P criteria based on the Structured Interview for Psychosis Risk Syndromes (SIPS),
  4. shows at least mild role functioning impairment on the Global Functioning-Role scale (GF:R),
  5. parent is willing to provide permission (and client is willing to assent) for invest coaches to communicate with treatment providers.

Exclusion:

  1. Previously met diagnostic criteria for full psychosis on the Structured Interview for Psychosis Risk Syndromes.
  2. Does not meet inclusion criteria listed above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05114733


Contacts
Layout table for location contacts
Contact: Michelle Friedman-Yakoobian 617-754-1210 mfriedm3@bidmc.harvard.edu
Contact: Michelle West MICHELLE.WEST@CUANSCHUTZ.EDU

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center/ Massachusetts Mental Health Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Michelle Friedman-Yakoobian, PHD Department of Psychiatry at BIDMC - a major teaching hospital of Harvard Medical School
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Michelle Friedman-Yakobian, Assistant Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05114733    
Other Study ID Numbers: 2021P000689
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Friedman-Yakobian, Beth Israel Deaconess Medical Center:
clinical high risk for psychosis
psychosis risk syndrome
school functioning
intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders