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
- Diseases
- Schizophrenia, Bipolar disorder
- 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
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Sciences North Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| North Bay Regional Health Centre Coordinator of this site? Confirm its status | North Bay | Canada | Unknown status |
| Durham Amaze- Lakeridge Health Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Niagara Region Public Health Coordinator of this site? Confirm its status | Thorold | Canada | Unknown status |
| First Place Clinic and Regional Resource Centre Coordinator of this site? Confirm its status | Thunder Bay | Canada | Unknown status |
| CMHA Waterloo Wellington Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.