Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): PsyGist and Clinician Manual
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
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).
Masking: None (Open Label)
Primary purpose: Other