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NCT03919760Completed

Early Psychosis Intervention - Spreading Evidence-based Treatment

Enhancing Evidence-Based Practice for Youth and Emerging Adults With Early Psychosis: Implementation and Evaluation in Diverse Service Settings

Source: ClinicalTrials.gov · Last updated 18 Mar 2026

Brief summary (registry, in English)

Implementation of 'NAVIGATE' in Ontario aims to help youth and emerging adults suffering from a first episode of psychosis. Although Ontario already has early psychosis intervention programs, the team's recent work has identified major challenges of delivering coordinated care, particularly those elements of care that enhance recovery. These challenges also exist nationally and internationally. By building on the already existing early psychosis intervention community of practice through the Early Psychosis Intervention Ontario Network, the investigators will implement NAVIGATE with the help of CAMH's Provincial System Support Program facilitators. The use of tele-videoconferencing through ECHO Mental Health Ontario and ECHO processes and protocols provide us with an opportunity to ensure sustainability. Using health administrative data held at the Institute for Clinical Evaluative Sciences (ICES), the investigators can examine system-level outcomes, including hospitalizations, emergency department visits, and outpatient physician visits of youth and emerging adults suffering from a first episode psychosis who are treated with NAVIGATE compared with those treated in early psychosis intervention programs without NAVIGATE and those who are not treated in early psychosis intervention programs. In addition, the investigators can also evaluate health care costs. Prior to initiating this project, the investigators obtained the input of youth and emerging adults with a first episode psychosis and family members. The investigators will also continue to measure engagement across the study. Hypotheses: 1. Following the implementation of NAVIGATE, program fidelity (i.e. adaptability) to the Ontario early psychosis intervention standard will improve. 2. Compared to patients not receiving NAVIGATE, those who receive NAVIGATE through this implementation study will have fewer days in hospital, fewer emergency department visits, fewer suicide attempts, lower mortality, and lower healthcare costs. 3. Improvements in functioning and symptoms will be comparable to the RAISE study (an earlier study assessing NAVIGATE); improvement may be influenced by demographic, socio-economic, geographic, and clinical factors. 4. The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.

Status (registry)
Completed
Study type
Interventional
Enrollment
100 (actual)
First submitted
19 Mar 2019
Start date
3 Jan 2020
Primary completion date
23 Dec 2024
Lead sponsor
Centre for Addiction and Mental Health
NCT number
NCT03919760

What you commit to

  • Study type: Interventional
  • Participants enrolled: 100
  • From 3 Jan 2020 to the primary completion date, 23 Dec 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Absence of psychosis
  • Inability to provide informed consent to participate in the research study

Criteria the registry did not label

  • Early psychosis intervention (EPI) programs from specific geographic regions of Ontario will be included. Investigators will recruit consecutive referrals to the EPI programs participating in the study. All of the EPI sites follow people experiencing a first episode psychosis.
  • Individual inclusion criteria:
  • Age range of 14-35 years;
  • any DSM-diagnosis that can manifest as early psychosis (schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance induced psychotic disorder, or unspecified psychotic disorder);

Age in the registry: 14 years to 35 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Health Sciences North
Coordinator of this site? Confirm its status
Greater SudburyCanadaUnknown status
North Bay Regional Health Centre
Coordinator of this site? Confirm its status
North BayCanadaUnknown status
Durham Amaze- Lakeridge Health
Coordinator of this site? Confirm its status
OshawaCanadaUnknown status
Niagara Region Public Health
Coordinator of this site? Confirm its status
ThoroldCanadaUnknown status
First Place Clinic and Regional Resource Centre
Coordinator of this site? Confirm its status
Thunder BayCanadaUnknown status
CMHA Waterloo Wellington
Coordinator of this site? Confirm its status
WaterlooCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.