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

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ClinicalTrials.gov Identifier: NCT05114733
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Michelle Friedman-Yakobian, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE October 1, 2021
First Posted Date  ICMJE November 10, 2021
Last Update Posted Date June 14, 2022
Actual Study Start Date  ICMJE March 15, 2022
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2021)
  • Feasibility of intervention- recruitment rate [ Time Frame: baseline ]
    recruitment rates
  • 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)
  • Feasibility of intervention- drop out [ Time Frame: 4 months ]
    drop outs
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2021)
  • Feasibility of intervention [ Time Frame: 4 months ]
    Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2021)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
Official Title  ICMJE Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
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.
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

The investigators will develop and test the feasibility of InVEST, an educational and vocational functioning intervention designed for youth at CHR-P, ages 12-18. InVEST streamlines CBT-P principles into an intervention model geared towards vocational and educational functioning.

InVEST is delivered individually by a "coach" (BA-level clinician) who can meet with youth at the clinic, by phone/ video, or in meetings in the community to provide support for implementing goals. Generally, sessions are once a week for one hour, but can be adjusted depending on client needs. The coach communicates with and serves as a member of a coordinated specialty care team (CSC) for CHR-P and collaborates with the client's individual therapist. The coach begins by identifying the youth's individualized goals and notes any difficulties with executive functioning, task initiation, and/or frustration tolerance. The coach then works with the client and therapist to develop a plan for taking action to accomplish goals and for practicing skills for improving organization, task initiation and managing frustration.

Study Procedures

Part 1: Development Phase/Open Trial Developing InVEST Manual: The investigators will develop an InVEST manual.

Recruitment: During the first year, the investigators will recruit 8 young people meeting broad CHR-P criteria from CEDAR or CHR-P research programs. Meeting broad diagnostic CHR-P criteria will be pre-determined through routine clinic assessments. Releases of Information's will be obtained from all participants upon recruitment to allow sharing of eligibility information for study recruitment. The investigators will slightly stagger these participants into 2 overlapping cohorts, to permit modifications to the protocol.

Refine and elaborate InVEST: Refinement will be an iterative process guided by our ongoing experiences in each of the stages. Additionally, the investigators will hold a focus group with the open trial participants, to inform refining the manual, particularly the initial InVEST assessment, which aims to guide how to individualize the intervention to particular client needs. The group will hold a meeting after each stage with all investigators and consultants to review and further refine the manual, including at the end of the development phase. The investigators will make changes to increase InVEST's acceptability, efficacy, efficiency, clarity, and developmental appropriateness. The open trial will inform what protocol accommodations are needed for younger adolescents, changes in content to sessions, whether and how age affects acceptability and feasibility, and whether the intervention needs to be simplified.

Assessments: Participants and a parent/ caregiver will complete 2 assessments (screening/baseline and post-treatment). Given our small sample size, treatment feasibility and accessibility are our primary outcomes. Our secondary outcome is role functioning. The investigators will acquire demographic variables and diagnosis from CEDAR records, and the investigators will conduct assessments on the following constructs: CHR-P symptoms; executive functioning; stress sensitivity; task initiation; hopelessness; and suicidality.

Focus Group Post-intervention, all open trial participants will be invited to participate in a focus group (n=8) to provide feedback on the intervention, and to inform manual development.

Part 2: Pilot Study Phase

Aims: The goals of the pilot study are to a) collect data on the feasibility and acceptability of InVEST, b) test and refine the provider training procedures, c) refine and pilot test provider adherence and competency measures, and d) preliminary investigation of InVEST's primary outcome (role functioning) and mechanisms (executive functioning, stress sensitivity, and task initiation).

Treatments: After obtaining all relevant consent and assent forms and completing their baseline assessment, participants will be randomized to either InVEST, or to a waitlist, Delayed Invest (DI) condition. Participants in the intervention condition will receive 4 months of InVEST treatment, then complete a post-treatment assessment and then a 4-month follow-up assessment. Delayed Invest participants will participate in their usual treatment without the addition of InVEST for their 4 months. Then, they will complete the 4-month assessment and begin working with an InVEST coach for the next 4 months, followed by a post-InVEST assessment. As a result, all participants will receive 3 assessments (which will allow the study assessment clinician to remain blind to study condition). Additionally, this procedure will allow for some consideration of change during the Delayed InVEST period, and for some consideration of stability after the intervention ends, and will permit all participants to receive the intervention. InVEST will be implemented as a 4-month intervention.

Assessments: Participants and a parent/ caregiver will complete 3 assessments (intervention: screening/baseline, post-treatment, 4-month follow-up; waitlist: screening/baseline, pre-treatment, post-treatment). Given our small sample size, treatment feasibility and accessibility are our primary outcomes. Our secondary outcome is role functioning.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Clinical High Risk for Psychosis
Intervention  ICMJE Behavioral: InVEST
Individualized vocational and educational support and training -- participant works with BA level school/ work coach for four months
Study Arms  ICMJE
  • Experimental: InVEST
    4 month treatment condition
    Intervention: Behavioral: InVEST
  • No Intervention: delayed invest
    participants in delayed invest wait four months and are reassessed before taking part in the intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2021)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Friedman-Yakoobian 617-754-1210 mfriedm3@bidmc.harvard.edu
Contact: Michelle West MICHELLE.WEST@CUANSCHUTZ.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05114733
Other Study ID Numbers  ICMJE 2021P000689
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Michelle Friedman-Yakobian, Beth Israel Deaconess Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Friedman-Yakoobian, PHD Department of Psychiatry at BIDMC - a major teaching hospital of Harvard Medical School
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP