Recruiting

SCM vs. SM

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05509998

Conditions

First Episode Psychosis (FEP)

Clinical High Risk for Psychosis (CHR)

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Not accepted

Interventions

Screening Method (SM)

Screening and Communication Method (SCM)

Study Details

Brief summary:

The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.

Conditions

First Episode Psychosis (FEP)

Clinical High Risk for Psychosis (CHR)

Study ID

NCT05509998

Start date

May 1, 2023

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 12- 30
  • ability to participate in assessments in English or Spanish
  • ability to provide informed consent (assent for those under age 18)

Exclusion Criteria:

  • previous diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.

Study Design

Enrollment

912 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Screening Method (SM)

In the SM condition all consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs.

experimental: Screening and Communication Method (SCM)

In the SCM condition, the same screening and evaluation procedures described above will continue, but clinicians conducting evaluations and making referrals will be trained to discuss findings and provide referrals using the ComPsych model. Following the evaluation, the clinician who conducted the evaluation will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty FEP or CHR services, as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs.

Interventions

Screening Method (SM)

All consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate.

Screening and Communication Method (SCM)

Clinicians will be trained to discuss findings and provide referrals using the ComPsych model. ComPsych prepares clinicians to effectively communicate diagnostic, prognostic and treatment information about FEP and CHR with patients and families, using a model that instils realistic hope and provides information effectively to encourage shared decision making about treatment. All consecutive patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Following the evaluation, the clinician will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty services, as appropriate.

Primary outcome measure

  • Duration of untreated psychosis (DUP) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Yulia Landa, PsyD, MS

212-585-4658yulia.landa@mssm.edu

Rachel Jespersen, MSW

212-585-4641rachel.jespersen@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Yulia Landa, PsyD, MS

212-585-4658yulia.landa@mssm.edu

Rachel Jespersen, MSW

212-585-4641rachel.jespersen@mssm.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

  • Duration of Untreated Psychosis (DUP)
  • Screening
  • Communication
  • First Episode Psychosis (FEP)
  • Clinical High Risk for Psychosis (CHR)
  • Coordinated Specialty Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.