Staged Treatment in Early Psychosis (STEP): A sequential multistage randomized clinical trial (SMART) of interventions for Ultra High Risk (UHR) of psychosis patients.

Not Applicable

Completed

• Conditions: Schizophrenia and other psychotic disorders; Mental Health - Schizophrenia; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12616000098437
• Lead Sponsor: Orygen Youth Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-01
• Study Completion: 2021-04-08
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

1.Age 12 -25 years (inclusive) at entry

2.Ability to speak adequate English (for assessment purposes)

3.Ability to provide informed consent. Where participants are minors (i.e. have not reached the age of eighteen), consent will also be obtained from one of the participant’s parents or legal guardian. Both the parent/legal guardian and participant will be required to sign a consent form in such a case. It will be the investigator’s responsibility to determine whether a participant who is a mature minor has the capacity and competence to consent to the study.

4.Meeting one or more UHR for psychosis groups:

Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning or sustained low functioning during the past year.

Attenuated Psychotic Symptoms (APS) Group: Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.

Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.

Exclusion Criteria

1. Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not.

2. Attenuated psychotic symptoms only present during acute intoxication.

3. Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy.

4. Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences.

5. Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder.

6. Premorbid IQ<70 and a documented history of developmental delay or intellectual disability.

7. Previous or current SCID diagnosis of Bipolar I.

Study & Design

• Study Type: Interventional
• Study Design: Not specified