PRIME vs Usual Care for Clinical High Risk

Yale University16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Clinical High Risk Syndrome for Psychosis

Interventions

PRIME careOTHER

Specialist medication, cognitive behavior therapy, family-focused therapy

Usual careOTHER

Medication and psychotherapy as available form community providers

Eligibility

Sex: ALLMin age: 12 YearsMax age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

Prevention through Risk Identification Management and Education (PRIME) Clinic

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Global Assessment of Functioning

Time frame: 24 months

Secondary Outcomes

Service utilization

hospitalizations and emergency room use

Time frame: 24 months

Data from ClinicalTrials.gov

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