PRIME vs Usual Care for Clinical High Risk

Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02960451

Enrollment

Registered

2016-11-09

Start date

2015-01-31

Completion date

2019-05-01

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical High Risk Syndrome for Psychosis

Keywords

prodrome, cognitive behavioral therapy, family focused therapy

Brief summary

The purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.

Detailed description

This study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.

Interventions

OTHERPRIME care

Specialist medication, cognitive behavior therapy, family-focused therapy

OTHERUsual care

Medication and psychotherapy as available form community providers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 30 Years

Healthy volunteers

Inclusion criteria

* Subjects must meet all of the following: 1. Male or female between 12 and 30 years old. 2. Understand and sign an informed consent (or assent for minors) document in English. 3. Meet diagnostic criteria for prodromal syndrome as per COPS criteria.

Exclusion criteria

* Subjects must not meet any of the following: 1. Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms. 2. Impaired intellectual functioning (full-scale IQ\<70). However, those with an IQ in the 65-69 range will not be excluded if they score \>75 on the WRAT Reading. 3. Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment. 4. Alcohol or substance dependence in the past 6 months.

Design outcomes

Primary

Measure	Time frame
Global Assessment of Functioning	24 months

Secondary

Measure	Time frame	Description
Service utilization	24 months	hospitalizations and emergency room use

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026