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Feasibility of an Early Detection Program for Early Psychosis on a College Campus

Primary Purpose

Psychosis, First Episode Psychosis, Clinical High Risk for Psychosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening
Warm Hand-Off
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Psychosis

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 15-30 year-old college students who present to the University of New Mexico (UNM) Early Program or the UNM CONNECT program for an intake,
  2. 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
  3. agree to participate in the study.

Exclusion Criteria:

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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Treatment as Usual

Screening

Screening Plus Warm Hand-Off

Arm Description

Treatment as usual enhanced with a brief psychosis literacy training (45-60 minutes) for the counselors at the university's student health and counseling center

Implementation of the Prodromal Questionnaire - Brief, which is a screening tool to detect risk of psychosis.

Addition of a warm hand-off to coordinated specialty care (CSC) for those determined eligible on the screening tool.

Outcomes

Primary Outcome Measures

Duration of Untreated Psychosis (DUP)
Measured among those who meet criteria for first episode psychosis using the Circumstances of Onset and Relapse Schedule.

Secondary Outcome Measures

Number of steps to coordinated specialty care
Measured among those who meet criteria for first episode psychosis or clinical high risk using the Circumstances of Onset and Relapse Schedule.
Perceived barriers to seeking psychological help
Measured among those who meet criteria for first episode psychosis or clinical high risk by the Barriers to Seeking Psychological Help Scale (BSPHS). The self-report scale includes 17 items rated on a five point scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Responses corresponding to 5 subscales are summed and range from either 4 to 20 or 3 to 15 with higher scores indicative of higher perceived obstacles. The five subscales include: (1) fear of being stigmatized by society, (2) trust in the mental health professional, (3) difficulties in self-disclosure, (4) perceived devaluation, and, (5) lack of knowledge. See citation for further scoring information for subscales.

Full Information

First Posted
June 5, 2019
Last Updated
February 6, 2023
Sponsor
University of New Mexico
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03983421
Brief Title
Feasibility of an Early Detection Program for Early Psychosis on a College Campus
Official Title
Feasibility of an Early Detection Program for Early Psychosis on a College Campus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. Preliminary estimates of effectiveness with respect to the intervention will also be provided.
Detailed Description
Specific Aims: Feasibility of an Early Detection Program for Early Psychosis on a College Campus Long duration of untreated psychosis (DUP) is associated with poor outcomes, including higher rates of suicide, hospitalization, and overall low functioning. More widespread use of effective strategies to decrease DUP are needed to address the substantial discrepancy between the actual (i.e., on average 2 years) and recommended time (i.e., 3 months) between the appearance of psychotic symptoms and the initiation of treatment. Early detection (ED) programs aim to decrease DUP by increasing case identification and removal of barriers to coordinated specialty care (CSC). The most studied components of ED programs include: (i) educational campaigns; ED response teams designed to optimize the referral processes to CSC; and to a lesser extent, screening among high-risk groups. While results of studies on individual ED components have been inconsistent, combinations of ED components have had more success in reducing DUP. For example, the Treatment and Intervention in Psychosis ED program, which included educational campaigns and ED teams, reported an average decrease in DUP from 1.5 years to 0.5 years pre-post implementation. The evidence on community-based ED programs is large and growing but very little is known about the effectiveness of ED services on college campuses in the United States. This gap in the literature is problematic because, with the first symptoms of psychosis being most likely to surface among college age young adults, college campuses are critical locations to identify and refer individuals to CSC who are at increased risk of first episode psychosis (FEP). The investigators aim to address this gap in the literature. The long-term goal of this program of research is to improve clinical and functional outcomes among college students with early stages of psychosis by reducing DUP. The objective of the proposed study is to determine the feasibility of an ED program that aims to: (i) identify college students at CHR of psychosis or with FEP, and (ii) efficiently link them to CSC services for a 2nd stage screen and a clinical assessment among those determined eligible. Students will be referred to treatment based on the results of the assessment (the University of New Mexico Department of Psychiatry CSC program includes clinical services for both FEP and CHR). The investigators will also provide preliminary estimates of effectiveness with respect to the intervention. The ED program will include two organizational level changes. First, a universal screening will be implemented (i.e., the Prodromal Questionnaire Brief) for psychosis among college students who are seeking help at a college counseling center. Second, a collaborative, person-centered, and rapid referral process (<2 weeks) to CSC will be implemented. Person-centered elements of the referral process include shared-decision making and a warm handoff (i.e., transfer of care between the college counseling center and CSC with the student present). The organizational-level changes will be facilitated by training, monthly meetings, and a decision support tool. The focus on these two components was informed by: (i) input collected from the existing CSC clinical team, college counseling center staff, and students through campus-based meetings; (ii) evidence for universal screening and processes that facilitate rapid access to CSC; and (iii) the pathways to care literature showing a strong link between health system factors and extended DUP. The planned intervention will evaluate it based on a combination of two theoretical frameworks: (i) Precede-Proceed Public Health Model, and the (ii) RE-AIM. Mixed methods will be used to attain the objective and achieve the following two specific aims: Identify whether (i) case identification, and (ii) referral-related barriers to CSC are important targets for ED programs on college campuses. The number of referrals from the college counseling center to the CSC program in the preceding three years will be compared to the number received during the 2.5 years of implementation. Also, during the same time-period DUP will be compared, and pathways and perceived barriers to care between college students referred from the college counseling center and students presenting to CSC from other referral sources. The hypothesis is that through the two mechanisms of change, the number of college students referred to CSC will increase. The investigators also hypothesize that, among college students referred to CSC from the college counseling center compared to those presenting from other referral sources, DUP will be shorter among those with FEP, and there will be fewer steps and perceived barriers for students with FEP or at CHR. The psychosis literacy among referrers from the counseling center will be examined. The investigators hypothesize that psychosis literacy will increase pre-post implementation. Evaluate the feasibility of an ED program from the perspectives of various stakeholders. The proposed study is innovative because it will be pilot testing an ED program on a college campus. At the completion of the proposed research, the expected outcomes are preliminary data and knowledge on the feasibility of and effective targets for an ED program on a college campus. If determined feasible and effective, the proposed ED program has a high potential for widespread uptake and scale-up given the nominal costs and ease of replication of its components. The brief screener will be part of the routine intake and the warm handoff/rapid CSC access will be facilitated by CSC staff posing minimal burden on college counseling centers. With a diverse target population in terms of ethnicity and race, the findings will be generalizable to college campuses nationwide and may therefore ultimately impact DUP - a major public health problem.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, First Episode Psychosis, Clinical High Risk for Psychosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A staggered intervention design will be implemented with three distinct stages. 1. Treatment as usual enhanced with a brief psychosis literacy training (45-60 minutes) for counselors at a university's student health counseling center (SHAC); 2. implementation of a screening tool for risk of psychosis; 3. Addition of a warm hand-off to Coordinated Specialty Care (CSC)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as usual enhanced with a brief psychosis literacy training (45-60 minutes) for the counselors at the university's student health and counseling center
Arm Title
Screening
Arm Type
Other
Arm Description
Implementation of the Prodromal Questionnaire - Brief, which is a screening tool to detect risk of psychosis.
Arm Title
Screening Plus Warm Hand-Off
Arm Type
Other
Arm Description
Addition of a warm hand-off to coordinated specialty care (CSC) for those determined eligible on the screening tool.
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
Screening for Early Psychosis and Clinical High Risk of Psychosis
Intervention Type
Other
Intervention Name(s)
Warm Hand-Off
Intervention Description
Among those determined eligible, transfer of care between the student health and counseling center and the coordinated specialty care program outreach coordinator occurring over the phone while the student is in the counselor's office immediately following the results of the screening.
Primary Outcome Measure Information:
Title
Duration of Untreated Psychosis (DUP)
Description
Measured among those who meet criteria for first episode psychosis using the Circumstances of Onset and Relapse Schedule.
Time Frame
Measured at 1 day ( one time point only, which is upon admission to coordinated specialty care (CSC) and is operationalized as the onset of symptoms and admission to CSC for first episode psychosis.)
Secondary Outcome Measure Information:
Title
Number of steps to coordinated specialty care
Description
Measured among those who meet criteria for first episode psychosis or clinical high risk using the Circumstances of Onset and Relapse Schedule.
Time Frame
Measured at 1 day (one time point only, which is upon admission to coordinated specialty care (CSC) and is operationalized as the number of steps between the onset of symptoms and admission to CSC for first episode psychosis or clinic high risk.)
Title
Perceived barriers to seeking psychological help
Description
Measured among those who meet criteria for first episode psychosis or clinical high risk by the Barriers to Seeking Psychological Help Scale (BSPHS). The self-report scale includes 17 items rated on a five point scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Responses corresponding to 5 subscales are summed and range from either 4 to 20 or 3 to 15 with higher scores indicative of higher perceived obstacles. The five subscales include: (1) fear of being stigmatized by society, (2) trust in the mental health professional, (3) difficulties in self-disclosure, (4) perceived devaluation, and, (5) lack of knowledge. See citation for further scoring information for subscales.
Time Frame
Measured at 1 day (one time point only, which is upon admission to coordinated specialty care (CSC).)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 15-30 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Crisanti, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

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Feasibility of an Early Detection Program for Early Psychosis on a College Campus

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