Prescient FAQs - clinicians

Prescient FAQs - clinicians

TRAJECTORIES AND PREDICTORS IN THE CLINICAL HIGH RISK FOR PSYCHOSIS POPULATION: PREDICTION SCIENTIFIC GLOBAL CONSORTIUM

A client’s decision to participate in a study is an important personal decision. The following frequently asked questions provide detailed information about the PRESCIENT study. 

WHAT DOES ULTRA HIGH RISK FOR PSYCHOSIS MEAN?

People at Ultra High Risk (UHR) for psychosis have an elevated risk of developing a psychotic disorder compared to the general population because of particular symptoms and/or family history. Symptoms vary for different individuals, but can include feeling low in mood, feeling paranoid, or seeing or hearing things that they know aren’t there. Other people in the UHR group may not experience any of these symptoms, but they have a family member with a psychotic disorder and are finding it difficult to keep up with social and occupational tasks.

WHAT IS THE PRESCIENT STUDY ABOUT? 

PRESCIENT will examine a range of potential risk factors for young people at Ultra High Risk (UHR) for psychosis, with the aim of creating tools to better predict outcomes and inform tailored treatment plans. We will recruit a large number of participants across Australia, Asia and Europe – and collect a broad range of information about their symptoms, family history and biology. To achieve this, data will be pooled so that it can be used and re-used to help current and future generations.

WHY IS IT IMPORTANT TO STUDY PEOPLE OVER A LONGER TIMEFRAME? 

This study keeps track of participants over a long period of time (2 years). This gives us a better understanding of different mental health concerns and how they develop and change, which may help us improve early treatments. PRESCIENT will be run under the guidance of a Human Research Ethics Committee operated by Melbourne Health in addition to local ethics and/or governance committees within Australia and internationally. 

WHO WILL TAKE PART IN PRESCIENT? 

PRESCIENT participants will include young people at ‘Ultra High Risk’ (UHR) for psychosis. The study will also include young people who have not experienced mental health concerns so that we can compare their mental health over time. Participants will know which group they are allocated to. 

HOW MANY PEOPLE ARE GOING TO TAKE PART IN PRESCIENT?

It is expected that up to 1,102 participants will take part in PRESCIENT over a two-year period.

HOW LONG WILL PRESCIENT GO FOR?

Participants will be recruited over a two-year period and follow up will go for two years. In total, we expect PRESCIENT to run for four years. 

The study is expected to go from July 2021 to June 2025. 

WHERE ARE THE PRESCIENT STUDY SITES?

The study is being conducted at the following sites and centres across Australia, Asia and Europe: 

Australia

•   Orygen Specialist Program (Melbourne, Victoria) and Orygen Clinical Trials Unit (OCTU); 

•   headspaces Craigieburn, Glenroy, Melton, Sunshine and Werribee (Melbourne, Victoria); and 

•   headspace and headspace Early Psychosis program in Adelaide (Adelaide, South Australia).

Asia 

•   Department of Psychiatry, University of Hong Kong (Hong Kong);

•   Early Psychosis Intervention Program Clinic (Singapore); and

•   Gwangju Early Treatment & Intervention Clinic (South Korea).

Europe 

•   Academic Medical Centre (The Netherlands); 

•   Centre for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital (Switzerland); 

•   Copenhagen Research Centre for Mental Health (Denmark); 

•   Forward Thinking Birmingham (United Kingdom); and

•   The University Hospital Jena, Department of Psychiatry (Germany).

University Hospital of Cologne (UHC), Cologne, Germany

WHAT TYPES OF THINGS WILL BE LOOKED AT OVER THE 24 MONTHS? 

•   Clinical interviews: Participants will be asked about their day-to-day life and activities, behaviour, emotions and moods over the two-year period.

•   Neurocognitive tasks: Participants will complete tasks that assess their attention and memory, and the way they respond to stimuli. 

•   Electrical brain activity recording (EEG): Participants will have EEGs. EEGs detect electrical activity in your brain using small metal discs (electrodes) attached to a person’s scalp.

•   Brain imaging scan (MRI): Participants will complete functional and structural MRI scans so their brain functioning can be observed over time. 

•   Blood sample: Participants will provide blood samples to analyse potential biomarkers of psychosis risk.

•   Saliva sample: Participants will provide saliva samples to monitor levels of the stress hormone cortisol. 

•   Speech sample: Participants will be asked to have a 20-minute audio-recorded open conversation with a Research Assistant. Speech patterns and their association with thought disorder will be assessed. 

•   Video sample:  With consent a participant’s image will be recorded via video so that facial characteristics can be analysed. 

•   Participants will be invited to record their daily mood and behaviour through a smartphone app (this will be optional). 

HOW DO PARTICIPANTS CONSENT TO THE PRESCIENT STUDY?

To participate in PRESCIENT, prospective participants need to be current clients at one of the centres listed above or live nearby. If a young person appears to be eligible, a research assistant will approach them to ask if they would like to take part in the project. A consent discussion will then be arranged.  You can also email prescientstudy@orygen.org.au to enquire as to whether your client might be eligible.

WHAT AGE DOES SOMEONE HAVE TO BE TO JOIN PRESCIENT?

Young people between 12 and 30 years of age, inclusive, can participate in the study. 

IF A POTENTIAL PARTICIPANT IS TURNING 31 SOON, CAN THEY STILL PARTICIPATE IN THE STUDY?

Yes, if they are enrolled in the study while still aged 30. 

IS THERE ANY FINANCIAL EXPENSE FROM PARTICIPATING IN PRESCIENT? 

There are no costs associated with participating in the research project, nor will participants be paid. Participants will, however, be reimbursed for their time and expenses associated with completing the research assessments. A breakdown of reimbursements is provided in the consent form.

WHAT HAPPENS IF MY CLIENT BEGINS PRESCIENT AND THEN DECIDES THEY NO LONGER WANT TO CONTINUE? 

The study is voluntary, and all participants have the right to withdraw from the study at any point. If a participant would like to withdraw, it is important for them to let the research assistant know to ensure the appropriate care can be provided. 

WHAT HAPPENS IF MY CLIENT NEEDS TO BE REFERRED TO ANOTHER SERVICE DURING PRESCIENT?

If your client needs to be referred to another service during the study period, please notify the Research Assistant.

CAN A CLIENT EXPERIENCING THE SYMPTOMS MENTIONED ABOVE TAKE PART IN PRESCIENT IF THEY ARE NOT ATTENDING A STUDY SITE?

Yes. Young people can take part in PRESCIENT even if they are not clients at one of the centres listed above, as long as they are receiving some kind of support including from a GP or an external psychologist or psychiatrist. However, the study team encourages young people seeking support to contact their local centre.

HOW WILL RISK BE MANAGED FOR PARTICIPANTS WHO ARE NO LONGER AT THE SERVICE WHEN FOLLOW-UP INTERVIEWS ARE COMPLETED? 

Participants will be assessed for risk at all follow-up research time-points. Participants identified as at risk or in distress will be provided crisis numbers and encouraged to engage with their GP and the appropriate mental health service.

WHAT DO I NEED TO DO AS A CLINICIAN OF A PARTICIPANT? 

There is no extra work required for clinicians. All appointments and assessment procedures are organised by the research assistants. Research assistants will liaise with you if there is any concern regarding risk of the participant. If you experience any concerns regarding a study participant, we request you discuss this with the research assistant at your client’s allocated centre.

WHO DO I CONTACT TO REFER A CLIENT TO THE PRESCIENT STUDY?

Participants can be referred for study enrolment by their treating clinician at one of the centres listed above. Clinicians, interested young people and their parents can also get in touch with the study team at prescientstudy@orygen.org.au , who will respond and keep a record of the enquirer’s details.

Only young people who consent and meet all of the inclusion and none of the exclusion criteria will be eligible to participate in PRESCIENT. 


INCLUSION CRITERIA 

All participants

•   are aged 12–30 years inclusive; 

•   understand and sign informed consent; and

•   meet UHR or healthy control criteria.

UHR participants

•   meet one or more UHR for psychosis groups as assessed by the CAARMS or SIPS, SOFAS and FIGS.

HC participants

Healthy control participants will be recruited from the community. They must not meet any exclusion criteria or: 

•   meet UHR criteria, have a current or past Cluster A personality disorder (Paranoid, Schizoid and Schizotypal Personality Disorders), or a current or past psychotic disorder; 

•   be receiving any current treatment with psychotropic medication; or 

•   have a family history (in first-degree relatives) of psychotic spectrum disorders. 


EXCLUSION CRITERIA

Participants will be considered ineligible if they have:

•   Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of >50 mg, estimated based on available information (e.g., medical file documentation, patient and family report).

•   Documented history of intellectual disability.

•   Past or current clinically significant central nervous system disorder. When necessary, Research Assistants will consult with study team investigators (including medical personnel) to determine if the central nervous system disorder is deemed to be clinically relevant. 

•   Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument.

•   Current or past treated or untreated psychotic episode as assessed by the CAARMS or SIPs.

 

WITHDRAWAL CRITERIA

Participants are free to withdraw their participation in PRESCIENT at any time. A participant will be considered ‘withdrawn’ from PRESCIENT in cases where all involvement is ceased.

Withdrawal from PRESCIENT will occur if consent is withdrawn either by the participant or their parent/guardian.

Participants who withdraw from PRESCIENT will be asked about the reason(s) for their withdrawal and about the presence of any medical concerns.

HREC/68873/MH-2021