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InVEST Program for High Risk for Psychosis (InVEST Trial)

N/A

Recruiting

Led By Michelle Friedman-Yakoobian, PHD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-22

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 4 months and baseline to 8 months

Awards & highlights

InVEST Trial Summary

This trial is testing a new intervention called InVEST for people at high risk for psychosis. The goal is to see if it can help with the specific difficulties that come with this phase. There will be an open trial with 8 participants first, to refine the intervention and make sure it is feasible and acceptable. Then there will be a randomized controlled trial with 30 participants, comparing InVEST to a delayed version of InVEST. The goal is to gain a preliminary understanding of the intervention's efficacy for the difficulties experienced by young people at CHR-P.

Who is the study for?

This trial is for English-speaking individuals aged 12-18 who are at high risk for psychosis, as determined by a specific interview process. They must have some difficulty with daily roles and their parent must agree to allow communication between the trial coaches and treatment providers.Check my eligibility

What is being tested?

The InVEST program is being tested in two parts: an initial phase to assess feasibility and refine methods, followed by a randomized controlled trial comparing immediate InVEST intervention against delayed (DI) intervention to evaluate its effectiveness in improving role functioning.See study design

What are the potential side effects?

Since InVEST involves educational and vocational support rather than medication, typical medical side effects are not expected. However, participants may experience stress or anxiety related to new challenges or changes in routine during the program.

InVEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 22 years old.

InVEST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 4 months and baseline to 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 4 months and baseline to 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 4 months and baseline to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of intervention -Client Satisfaction

Feasibility of intervention- drop out

Feasibility of intervention- recruitment rate

Secondary outcome measures

Role functioning

InVEST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InVESTExperimental Treatment1 Intervention

4 month treatment condition

Group II: delayed investActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,248 Total Patients Enrolled

Michelle Friedman-Yakoobian, PHDPrincipal InvestigatorDepartment of Psychiatry at BIDMC - a major teaching hospital of Harvard Medical School

Media Library

InVEST Clinical Trial Eligibility Overview. Trial Name: NCT05114733 — N/A

High Risk for Psychosis Research Study Groups: delayed invest, InVEST

High Risk for Psychosis Clinical Trial 2023: InVEST Highlights & Side Effects. Trial Name: NCT05114733 — N/A

InVEST 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114733 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can people qualify to take part in this clinical experiment?

"This research trial has a participant requirement of 12 to 18 year olds suffering from psychosis and is seeking approximately 24 participants."

Answered by AI

Are there still vacancies available in this research program?

"According to information provided on clinicaltrials.gov, this investigation is presently recruiting participants. The study details were initially published on March 15th 2022 and updated most recently on June 10th 2022."

Answered by AI

Is the eligibility criteria of this research protocol limited to adults aged 18 or older?

"As per the conditions of this trial, only minors between ages 12 and 18 can be considered eligible for enrollment."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. The clinical trial is recruiting participants, as noted by the information on clinicaltrials.gov; this study was first announced on March 15th 2022 and most recently updated June 10th 202022. Currently, 24 individuals are needed to be recruited at one location."

Answered by AI

Recent research and studies

Early Intervention in PsychiatryJournal

Individualized Vocational and Educational Support and Training for Youth at Clinical High Risk for Psychosis

West, Michelle L., Emma M. Parrish, James Green, Caroline Howland, and Michelle Friedman‐Yakoobian. 2021. “Individualized Vocational and Educational Support and Training for Youth at Clinical High Risk for Psychosis”. Early Intervention in Psychiatry. Wiley. doi:10.1111/eip.13186.

Early Intervention in PsychiatryJournal

Treatment Outcomes for Young People at Clinical High Risk for Psychosis: Data from a Specialized Clinic

West, Michelle L., Emma M. Parrish, and Michelle Friedman‐Yakoobian. 2021. “Treatment Outcomes for Young People at Clinical High Risk for Psychosis: Data from a Specialized Clinic”. Early Intervention in Psychiatry. Wiley. doi:10.1111/eip.13187.

Early Intervention in PsychiatryJournal

Individualized Vocational and Educational Support and Training for Youth at Clinical High Risk for Psychosis

Early Intervention in PsychiatryJournal

Treatment Outcomes for Young People at Clinical High Risk for Psychosis: Data from a Specialized Clinic