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CompletedNCT02960451Updated May 28, 2019

PRIME vs Usual Care for Clinical High Risk

An interventional study of PRIME care and Usual care in Clinical High Risk Syndrome for Psychosis, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2019-05-28.

Sponsored by Yale University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
12 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Clinical High Risk Syndrome for Psychosis

Keywords

  • prodrome
  • cognitive behavioral therapy
  • family focused therapy
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    PRIME care

    Specialized care in the PRIME clinic

    Other: PRIME care

  • Active comparator
    Usual care

    Usual care in the community

    Other: Usual care

Interventions

  • OtherPRIME care

    Specialist medication, cognitive behavior therapy, family-focused therapy

  • OtherUsual care

    Medication and psychotherapy as available form community providers

06

What researchers measure

Primary outcomes

  1. Global Assessment of Functioning

    Time frame: 24 months

Secondary outcomes

  1. Service utilization

    hospitalizations and emergency room use

    Time frame: 24 months

07

Study locations

1 site
  • Prevention through Risk Identification Management and Education (PRIME) Clinic
    New Haven, Connecticut 06519, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02960451
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Nov 9, 2016
Start date
Jan 2015
Primary completion
May 1, 2019
Completion
May 1, 2019
Last update
May 28, 2019

Study contacts

Scott Woods, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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