NCT04497857

Brief Summary

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

6 active sites

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

July 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 16, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

July 31, 2020

Last Update Submit

December 23, 2025

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform DisordersMajor Depression With Psychotic FeaturesBipolar Disorder With Psychotic Features

Keywords

psychosis

Outcome Measures

Primary Outcomes (1)

  • Annualized hospitalization rates

    To determine if CSC-TH, as compared to CSC-SD, is associated with superior clinical outcomes by counting the number of hospitalizations in a year

    12 months

Secondary Outcomes (5)

  • Number of participants hospitalized

    12 months

  • Time (days) to first hospitalization

    12 months

  • Symptom outcomes assessed by the Modified Colorado Symptom Index (MCSI)

    12 months

  • Symptom outcomes assessed by the COMPASS-10

    12 months

  • Functioning outcomes assessed by the MIRECC-GAF

    12 months

Study Arms (2)

CSC-SD

PLACEBO COMPARATOR

Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.

Other: Coordinated Specialty Care (CSC)

CSC-TH

EXPERIMENTAL

Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.

Other: Coordinated Specialty Care (CSC)

Interventions

Coordinated Specialty Care (CSC)OTHER

CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

CSC-SDCSC-TH

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between 16 and 35 years of age
  • Able to give informed consent
  • Willing and able to adhere to the study schedule
  • New intakes enrolled in one of the six clinical programs
  • Non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major depression with psychotic features, bipolar disorder with psychotic features) psychotic disorders with onsets within 5 years of enrollment.

You may not qualify if:

  • \. Known IQ \< 70 based on participant report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Prevention and Recovery Center for Early Psychosis

Indianapolis, Indiana, 46202, United States

Location

Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University

New Orleans, Louisiana, 70119, United States

Location

Program for Risk Evaluation and Prevention (PREP) - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Strong Ties Young Adults Program- University of Rochester Medical Center

Rochester, New York, 14623, United States

Location

The Early Psychosis Intervention Center (EPICENTER) at Ohio State

Columbus, Ohio, 43210, United States

Location

Vanderbilt's Early Psychosis Program - Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Alan Breier

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Raymond E. Houk Professor of Psychiatry

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

March 16, 2022

Primary Completion

July 29, 2025

Study Completion

July 29, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(6)