Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk … (NCT04325568) | Clinical Trial Compass
CompletedPhase 1
Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis
United States25 participantsStarted 2020-11-16
Plain-language 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.
Who can participate
Age range
16 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Perceived Treatment Efficacy
Timeframe: Baseline, immediately post-intervention, up to 30 minutes
2
Change From Baseline in Intention to Use Treatment
Timeframe: Baseline, Immediately post-intervention, up to 30 minutes