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Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

Developing Biomarker-Supported SSD Prevention

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
9 Years to 19 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a short, family-based program for children and young adults with a family history of schizophrenia spectrum disorders (SSD), illnesses that can affect thoughts and sense of reality. It aims to reduce ongoing, upsetting experiences that resemble psychosis, such as trouble telling what is real. The study compares effects in people whose brain patterns look more or less like those linked to SSD.

The purpose of this study is to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have blood relatives who have or likely have SSD or a similar severe mental illness. The family link must meet study rules and be confirmed in an interview.
  • Have at least two risk factors that the program aims to change.
  • Both the participant and their parent(s) or legal guardian(s) agree to take part.
  • Have stable mental health and no major changes in medicines for depression, attention, or psychosis in the past 4 weeks.

Who can't join

  • Have now or have had a psychotic disorder, or signs of high risk for psychosis, based on a study interview.
  • Take or have taken antipsychotic medicine specifically to treat a psychotic disorder.
  • Have a major medical condition or a major condition affecting the brain or nerves.
  • Have moderate to severe difficulties with learning and everyday skills, or milder difficulties that would make study tests hard to complete.
  • Currently use drugs or alcohol in a way that affects daily life or taking part in the study.
  • Cannot give the agreement or permission needed to join.
  • Cannot have an MRI, a scan that takes pictures inside the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Family history of SSD (defined as first-degree (e.g., a parent or a sibling), second-degree (e.g., an uncle or a grandparent), or other combinations of biological relatives in the family have or likely have a diagnosis of SSD or other closely related severe mental illnesses equivalent to at least 25% of genetic sharing) per medical record review and/or parent/legal guardian report and confirmed by a structured interview * screening positive for two or more risk factors targeted by the intervention * Participants and parent(s)/legal guardian(s) agree to participate * psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks. Exclusion Criteria: * Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview * Current or past antipsychotic medication use to specifically treat a psychotic disorder * major medical and neurological conditions * moderate to severe intellectual disabilities or mild intellectual disabilities but expected to have difficulty completing the study assessments; * current drug or alcohol use that impacts functioning and study engagement; * Not able to give assent, permission, or consent. * Not able to undergo MRI.

Study sites (1)

TX