PsychosisPhase 1NCT04325568
Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis
A Phase 1 study testing PsyGist and Clinician Manual in people with Psychosis, run by New York University at 1 site in United States.
Trial 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'. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Psychosis
- What is being tested?
- PsyGist and Clinician Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 31 Jul 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Developing Clinical Translational Tools to Communicate Genetic Risk Among Individuals Who Are at Clinical High Risk for Psychosis
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.
Read the 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
- Being tested
- PsyGist and Clinician Manual
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsyGist and Clinician ManualBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: 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. Receives: Behavioral: PsyGist and Clinician Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Immediately post-intervention, up to 30 minutes
Secondary outcomes (3)
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development
Assess participants self-stigma if they were told they had a genetic risk for psychosis. 7 items are included: I believe I would be fundamentally different from most people (range 1-4), I would be more likely to do something violent towards other people (range 1-4), I would be more likely to do something violent towards myself (range 1-4), I would be more likely to be unpredictable (range 1-4), I would feel ashamed of myself (range 1-4), I would feel embarrassed about myself (range 1-4), I would think of myself as less competent (range 1-4). each measured on a 4-point scale (1=strongly disagree, 2=somewhat disagree, 3=somewhat agree, 4=strongly agree), with higher scores indicating greater stigma. Change in scores from pre- to post-intervention are reported.
Measured: Baseline, Immediately post-intervention, up to 30 minutes
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development
Assess participants anticipated discrimination if they were told they had a genetic risk for psychosis. 18 items (each with a range of 1-4) are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater anticipated stigma. Because this is an exploratory R21 trial, the investigators are also testing and validating new measures for this specific group and purpose however, this is based off a published discrimination scale (Wahl, 1999). Change in scores from pre- to post-intervention for each item are reported.
Measured: Baseline, Immediately post-intervention, up to 30 minutes
Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development
Assess participants anticipated rejection if they were told they had a genetic risk for psychosis. 3 items (each with a range of 1-4) measured on a 4-point scale (1=very unconcerned, 2=somewhat unconcerned, 3=somewhat concerned, 4=very concerned), with higher scores indicating greater anticipated rejection. Because this is an exploratory R21 trial, the investigators are also testing and validating new measures for this specific group and purpose; however, these items are based off of a published rejection sensitivity scale (Link, Wells, Phelan, Yang, 2015). Change in scores from pre- to post- intervention for each item are reported.
Measured: Baseline, Immediately post-intervention, up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start16 Nov 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Responsible party
- Sponsor
- Investigators
- Lawrence Yang, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325568
- Sponsor's protocol ID
- 1R21HG010420
- Status last verified
- Jan 2023
- First submitted
- 31 Oct 2019
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Clinical Translational Tools to Communicate Genetic Risk Among Individuals Who Are at Clinical High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT04325568
- Acronym / sponsor ID
- 1R21HG010420
- Conditions
- Psychosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Clinician Manual | Other | Behavioral: PsyGist and Clinician ManualParticipants 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'. |
| AutoTutor (PsyGist) | Other | Behavioral: PsyGist and Clinician ManualAutoTutor 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. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsyGist and Clinician ManualThis 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). | Behavioural | AutoTutor (PsyGist), Clinician Manual |
Primary outcome
Change From Baseline in Perceived Treatment Efficacy
Time frame: Baseline, immediately post-intervention, up to 30 minutes
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.
Change From Baseline in Intention to Use Treatment
Time frame: Baseline, Immediately post-intervention, up to 30 minutes
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.
3 secondary outcomes
Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development
Time frame: Baseline, Immediately post-intervention, up to 30 minutes
Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development
Time frame: Baseline, Immediately post-intervention, up to 30 minutes
Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development
Time frame: Baseline, Immediately post-intervention, up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Psychosis
Recruiting
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
Sleep, Physical Activity
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Yang, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PsyGist and Clinician Manual in people with Psychosis, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Perceived Treatment Efficacy (time frame: Baseline, immediately post-intervention, up to 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.