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

NCT04325568 | Completed Phase 1 Results DMC

• 1 other identifier: 1R21HG010420
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Perceived Treatment Efficacy

  Asks participants to rate the likelihood that engaging in treatment and adaptive behaviors will reduce the risk for developing psychosis, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater perceived efficacy. Measure is divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (3 items range 3-12), and d) help-seeking behaviors (6 items range 6-24). Changes in scores from pre- to post-intervention are reported.

  Baseline, immediately post-intervention, up to 30 minutes

• Change From Baseline in Intention to Use Treatment

  Asks participants to rate the likelihood of engaging in treatment and adaptive behaviors, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater intention. The measure was divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (2 items range 2-8), and d) help-seeking behaviors (6 items range 6-24). Changes were measured pre- and post-intervention.

  Baseline, Immediately post-intervention, up to 30 minutes

Secondary Outcomes (3)

• Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development

  Baseline, Immediately post-intervention, up to 30 minutes

• Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development

  Baseline, Immediately post-intervention, up to 30 minutes

• Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development

  Baseline, Immediately post-intervention, up to 30 minutes

Study Arms (2)

Clinician Manual

OTHER

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'.

Behavioral: PsyGist and Clinician Manual

AutoTutor (PsyGist)

OTHER

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.

Behavioral: PsyGist and Clinician Manual

Interventions

PsyGist and Clinician Manual 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); Clinician Manual

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University: lead
• New York State Psychiatric Institute: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Lawrence Yang
• Organization: New York University

lawrence.yang@nyu.edu

(212) 992-6334

Study Officials

• Lawrence Yang, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be used. Again, the 27 participants will be assigned to the clinician manual and the next 27 participants will be assigned to Autotutor. The investigators are doing this in order to prevent contamination.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pre-post design (N=54) in which the first 27 participants will take part in the clinician manual intervention and the next 27 participants will be assigned to the AutoTutor. Participants will only complete either the clinical manual intervention or the AutoTutor intervention, but not both. These groups will not be compared to one another. Each participant will be assessed on all outcomes before and after the intervention and will only take part in either the clinician manual or Autotutor. Since each participant is only getting one intervention and the clinician manual and AutoTutor are not being compared to each other the most appropriate study design is single group (and cannot be considered factorial, crossover, parallel, or sequential).

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: March 27, 2020
• Study Start: November 16, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)