NCT03983421

Brief Summary

The objective of the proposed study is to determine the feasibility of an Early Detection program that aims to: (i) identify college students at clinical high risk (CHR) of psychosis or with first episode psychosis (FEP), and (ii) efficiently link them to coordinated specialty care (CSC) services for a 2nd stage screen, a clinical assessment, and appropriate treatment. The study will also determine pathways to care and perceived barriers to care among those students enrolled in Coordinated Specialty Care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

June 5, 2019

Results QC Date

January 7, 2024

Last Update Submit

March 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration of Untreated Psychosis

    Duration of Untreated Psychosis determined upon enrollment to coordinated specialty care

    Measured upon admission (baseline) to coordinated specialty care (CSC)

Secondary Outcomes (2)

  • Number of Steps to Coordinated Specialty Care

    Measured upon admission (baseline) to coordinated specialty care (CSC)

  • Perceived Barriers to Seeking Psychological Help

    Measured upon admission (baseline) to coordinated specialty care (CSC).

Study Arms (1)

Students Enrolled In Coordinated Specialty Care

The number of students determined eligible for Coordinated Specialty Care that were originally screened through the PQ-B at the college counseling center.

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study sample includes students enrolled in the University of New Mexico (UNM), Department of Psychiatry and Behavioral Health Sciences CSC program. At the time of the study, the UNM CSC Program included separate clinics for patients diagnosed with clinical high risk for psychosis (CHRp) or FEP.

You may qualify if:

  • year-old college students who present to the University of New Mexico (UNM) Early Program or the UNM CONNECT program for an intake,
  • screen positive for clinical high risk on the Structured Interview for Prodromal Syndromes (SIPS) or first episode psychosis on the Structured Clinical Interview for Diagnostic Statistical Manual IV
  • agree to participate in the study.

You may not qualify if:

  • below the age of 15 years old or above the age of 30,
  • not UNM college students,
  • screen negative for clinical high risk or first episode psychosis,
  • refuse to participate in the study,
  • cognitively unable to provide informed consent as demonstrated by a brief cognitive screen prior to completion of the enrollment interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (2)

  • Norman R, Malla A. Course of Onset and Relapse Schedule: Interview and Coding Instruction Guide.; 2002. Prevention and Early Intervention for Psychosis Program. Available from author.

    BACKGROUND
  • Topkaya N, Sahin E, Meydan B. The Development, Validity, and Reliability of the Barriers to Seeking Psychological Help Scale for College Students. Int J High Educ. 2017;6(1):48-62.

    BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Annette Crisanti, PhD
Organization
Department of Psychiatry and Behavioral Sciences, Health Sciences Center, University of New Mexico

Study Officials

  • Annette Crisanti, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 12, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 1, 2024

Results First Posted

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations