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NCT03970005

Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis

Enrolling by Invitation
Not specifiedAges 12–25Observational
Ohio State University
~100 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:Step-Based Care Model

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to remission of clinical-high risk status for psychosis
Measured over Remission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks

Conditions

Prodromal Schizophrenia

Explore related trials

Clinical High-Risk for Psychosis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Nicholas Breitborde, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Male and female patients between ages 12-25
Individuals meeting clinical high-risk criteria for psychosis as determined using the Structured Interview for Psychosis Risk. Inclusive of individuals meeting any of the three CHR syndromes assessed by the SIPS (i.e., attenuated psychotic symptoms; brief intermittent psychosis, and genetic risk and functional deterioration) and/or individuals at all four current status specifiers for the SIPS (i.e., progression, persistence, partial remission, and full remission) given evidence that future worsening of symptoms and/or progression to psychosis is possible for individuals in each current status specifier category.
Subjects with no evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4
Fluent in English per self-report

What this trial measures

  • Time to remission of clinical-high risk status for psychosisRemission status assessed at all treatment visits which will occur approximately once every week for up to 104 weeks

    Using criteria inspired by Nelson et al. (2018), remission of clinical high risk status for psychosis is defined as simultaneous remission of both (i) symptoms and (ii) functional deficits associated with prodromal psychosis. Remission of symptoms is defined as all positive symptom items scored less than 3 on the Structured Clinical Interview for Prodromal States (SIPS). Each item is rated from 0-6 with higher scores indicating greater severity of symptoms. Remission of functional deficits is defined as a 5-point increase on the Personal and Social Performance scale (PSP: Morosini et al., 2000) as compared to baseline assessment or the PSP score ≥ 70. Scores range from 0-100 with higher scores indicative of better personal and social functioning.