New staged treatment shows promise for preventing psychosis in At-Risk youth
NCT ID NCT02751632
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a step-by-step treatment approach for 342 young people aged 12-25 who are at ultra high risk of developing psychosis. The goal was to see if a sequence of therapies and medications could improve daily functioning and reduce the chance of psychosis. The approach uses a staged plan, starting with one treatment and adding others if needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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342 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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May 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA * Age 12 -25 years (inclusive) at entry. * Ability to speak adequate English (for assessment purposes). * Ability to provide informed consent. * Meeting one or more Ultra High Risk for psychosis groups as defined below: Group 1: Vulnerability Group Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV in identified patient AND Drop in Functioning: Recency: Change in functioning occurred within last year Impact: Social and Occupational Functioning Assessment Scale (SOFAS) score at least 30% below previous level of functioning and sustained for at least one month. OR Sustained low functioning: Recency: For the past 12 months or longer Impact: SOFAS score of 50 or less. Group 2: Attenuated Psychotic Symptoms Group 2a) Subthreshold intensity: Intensity: Global Rating Scale Score of 3-5 on Unusual Thought Content subscale, 3-5 on Non-Bizarre Ideas subscale, 3-4 on Perceptual Abnormalities subscale and/or 4-5 on Disorganised Speech subscales of the Comprehensive Assessment of At Risk Mental States (CAARMS). Frequency: Frequency Scale Score of 3-6 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS Duration: symptoms present for at least one week Recency: symptoms present in past year 2b) Subthreshold frequency: Intensity: Global Rating Scale Score of 6 on Unusual Thought Content subscale, 6 on Non-Bizarre Ideas subscale, 5-6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS Frequency: Frequency Scale Score of 3 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS Recency: symptoms present in past year Group 3: Brief Limited Intermittent Psychotic Symptoms Intensity: Global Rating Scale Score of 6 on Unusual Thought Content subscale, 6 on Non-Bizarre Ideas subscale, 5 or 6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS Frequency: Frequency Scale Score of 4-6 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales Duration: Symptoms present for less than one week and spontaneously remit on every occasion. Recency: symptoms present in past year EXCLUSION CRITERIA * Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not. * Attenuated psychotic symptoms only present during acute intoxication. * Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy. * Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences. * Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder. * Premorbid Intelligence Quotient (IQ) \<70 and a documented history of developmental delay or intellectual disability. * Current or previous SCID diagnosis of Bipolar I.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Headspace
Craigieburn, Victoria, 3064, Australia
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Headspace
Glenroy, Victoria, 3046, Australia
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Headspace
Sunshine, Victoria, 3020, Australia
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Headspace
Werribee, Victoria, 3030, Australia
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Orygen Youth Health Clinical Program
Melbourne, Victoria, 3052, Australia
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Other studies related to the condition(s) this trial covers.
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