PRIME vs Usual Care for Clinical High Risk

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

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.

Study Overview

• Status: Completed
• Conditions: Clinical High Risk Syndrome for Psychosis
• Intervention / Treatment: Other: PRIME care; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Prevention through Risk Identification Management and Education (PRIME) Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRIME care; Specialized care in the PRIME clinic	Other: PRIME care; Specialist medication, cognitive behavior therapy, family-focused therapy
Active Comparator: Usual care; Usual care in the community	Other: Usual care; Medication and psychotherapy as available form community providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Global Assessment of Functioning	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Scott Woods, MD, Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; prodrome; family focused therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 1411014943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO