Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis

NCT ID: NCT04325568

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2022-07-31

Brief Summary

While great strides are being made in identifying early signs that place people at a 'high risk state' for different illness conditions, at the same time, advances are being made in the identification of genes associated with 'high-risk states'. This study proposes to develop two innovative clinical tools that could greatly facilitate dissemination of a beneficial genetic malleability framing to high-risk youth in order to encourage increased treatment engagement and uptake of healthy behaviors. The impact of genetic information assumes special importance in the 'high-risk state' because achieving the best possible outcome is more likely if individuals actively choose to engage in beneficial treatment and health-promoting behaviors.

Detailed Description

This project seeks to understand how individuals already in a high-risk state will interpret genetic information informing risk of 'conversion' to a full disorder. How individuals interpret this possibility carries important consequences for how they choose to respond, which may range from fatalistic acceptance of the disorder to proactive preventative behavior. With the aim to encourage an active pro-health response, the investigators propose developing two tools for communicating genetic risk and evaluate them regarding their effectiveness in inducing a positive response to the risk of illness. The two tools will consist of: 1) a clinician manual, designed to be used by trained clinicians to communicate risk to CHR youth; 2) a high-impact, computerized tutorial ('AutoTutor') that has been used to convey genetic risk for breast cancer (i.e. BRCA gene). To create these two tools, experts in psychiatric genetics and stigma will work to develop the two tools to convey genetic risk information to youth and young adults identified as in a 'clinical high-risk state' (CHR) for psychosis. The investigators assess primary outcomes of increased intent to engage in treatment and healthy behaviors, and a secondary outcome of reduction in stigma. While specific genes for risk of psychosis are not yet used in diagnosis or treatment, a genetic malleability (GM) framing conforms to the known genetic risk for psychosis, and has a strong likelihood of being used in the not too distant future. Because of the relatively large innovation involved, the investigators seek to establish initial acceptability, safety, and efficacy of each tool. The investigators then use a nonrandomized, within- subject, pre- vs. post design to examine whether providing the genetic malleability framing via each tool (n=27 CHR youth per tool, N=54 total) leads to improved outcomes. For each tool, participants will be conveyed hypothetical information proposing being identified as having a substantially elevated, genetically-malleable risk for developing psychosis.

Conditions

Psychosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clinician Manual

Participants in the Clinician Manual arm will be introduced to a trained clinician and will complete one 60-minute session covering equivalent topics addressed in the PsyGist program. The manual will consist of: (1) a section exploring the youth's causal model for their high-risk state; (2) individualization per their causal model; and (3) tutorials that convey the main concepts of genetic malleability.

Clinicians will assess individual causal models via discussion with CHR youth about their at- risk state. Individualization of genetic framing will occur using youths' causal models and will fall into 1 of 3 categories (per PsyGist): 'primarily genetic', 'primarily environmental' or 'combined'.

Group Type: OTHER

PsyGist and Clinician Manual

Intervention Type: BEHAVIORAL

This is a pre-post test design aimed at conveying future genetic risk information to those at clinical high risk for psychosis. Participants will be assigned to either complete the Clinician Manual intervention (n= 27 participants) or PsyGist intervention (n=27 participants).

AutoTutor (PsyGist)

AutoTutor is an intelligent system that simulates talking with a human tutor. Our AutoTutor, called PsyGist, has 3 parts: (1) assessment of the youth's causal model for their high-risk state; (2) an individualized 'pre-tutorial' vignette matched to their causal model; (3) a 'tutorial' presenting the 'genetic malleability' framing.

PsyGist will guide participants through its three components.

Group Type: OTHER

PsyGist and Clinician Manual

Intervention Type: BEHAVIORAL

This is a pre-post test design aimed at conveying future genetic risk information to those at clinical high risk for psychosis. Participants will be assigned to either complete the Clinician Manual intervention (n= 27 participants) or PsyGist intervention (n=27 participants).

Interventions

PsyGist and Clinician Manual

This is a pre-post test design aimed at conveying future genetic risk information to those at clinical high risk for psychosis. Participants will be assigned to either complete the Clinician Manual intervention (n= 27 participants) or PsyGist intervention (n=27 participants).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male or females between the ages of 16- 30
• Current or previous COPE participant
• Identified as at clinical high risk for psychosis as defined as having at least one of the following: a)attenuated positive symptoms b)brief intermittent positive symptoms

Exclusion Criteria

• Meeting CHR via only the Genetic risk and deterioration (GRD) syndrome. If the participant meets the GRD syndrome only, the investigators exclude the rare Genetic risk + deterioration (GRD) syndrome (comprising <1% of CHR cases) because GRD requires having a 1st degree relative with any psychotic disorder, which may be linked with stronger reactions to genetic framings.
• IQ < 80
• Inability to adopt hypothetical situation

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21HG010420

Identifier Type: NIH

Identifier Source: org_study_id

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