Back to resultsPRIME vs Usual Care for Clinical High Risk
Primary Purpose
Clinical High Risk Syndrome for Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRIME care
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Clinical High Risk Syndrome for Psychosis focused on measuring prodrome, cognitive behavioral therapy, family focused therapy
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following:
- Male or female between 12 and 30 years old.
- Understand and sign an informed consent (or assent for minors) document in English.
- Meet diagnostic criteria for prodromal syndrome as per COPS criteria.
Exclusion Criteria:
Subjects must not meet any of the following:
- Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
- 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.
- Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
- Alcohol or substance dependence in the past 6 months.
Sites / Locations
- Prevention through Risk Identification Management and Education (PRIME) Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRIME care
Usual care
Arm Description
Specialized care in the PRIME clinic
Usual care in the community
Outcomes
Primary Outcome Measures
Global Assessment of Functioning
Secondary Outcome Measures
Service utilization
hospitalizations and emergency room use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02960451
Brief Title
PRIME vs Usual Care for Clinical High Risk
Official Title
Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk Syndrome for Psychosis
Keywords
prodrome, cognitive behavioral therapy, family focused therapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRIME care
Arm Type
Experimental
Arm Description
Specialized care in the PRIME clinic
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care in the community
Intervention Type
Other
Intervention Name(s)
PRIME care
Intervention Description
Specialist medication, cognitive behavior therapy, family-focused therapy
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Medication and psychotherapy as available form community providers
Primary Outcome Measure Information:
Title
Global Assessment of Functioning
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Service utilization
Description
hospitalizations and emergency room use
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following:
Male or female between 12 and 30 years old.
Understand and sign an informed consent (or assent for minors) document in English.
Meet diagnostic criteria for prodromal syndrome as per COPS criteria.
Exclusion Criteria:
Subjects must not meet any of the following:
Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
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.
Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
Alcohol or substance dependence in the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Woods, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention through Risk Identification Management and Education (PRIME) Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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PRIME vs Usual Care for Clinical High Risk
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