Clinical trial NCT04325568: Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis
Official title: Developing Clinical Translational Tools to Communicate Genetic Risk Among Individuals Who Are at Clinical High Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychosis
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: New York State Psychiatric Institute
First posted: 2020-03-27
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change From Baseline in Perceived Treatment Efficacy
timeFrame: Baseline, immediately post-intervention, up to 30 minutes
measure: Change From Baseline in Intention to Use Treatment
timeFrame: Baseline, Immediately post-intervention, up to 30 minutes
Secondary outcomes:
measure: Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development
timeFrame: Baseline, Immediately post-intervention, up to 30 minutes
measure: Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development
timeFrame: Baseline, Immediately post-intervention, up to 30 minutes
measure: Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development
timeFrame: Baseline, Immediately post-intervention, up to 30 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York University
name: Lawrence Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: