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PRIME vs Usual Care for Clinical High Risk

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT02960451
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
51.9
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PRIME care
  • Other: Usual care
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Global Assessment of Functioning [24 months]

Secondary Outcome Measures

  1. Service utilization [24 months]

    hospitalizations and emergency room use

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prevention through Risk Identification Management and Education (PRIME) Clinic New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Scott Woods, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT02960451
Other Study ID Numbers:
  • 1411014943
First Posted:
Nov 9, 2016
Last Update Posted:
May 28, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Yale University
prodrome
cognitive behavioral therapy
family focused therapy
Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders

Study Results

No Results Posted as of May 28, 2019