AzTrials
AzTrials

First Episode PsychosisEPI-SETNCT03919760

Early Psychosis Intervention - Spreading Evidence-based Treatment

A study testing NAVIGATE and Treatment as Usual in people with First Episode Psychosis and Schizophrenia, Childhood, run by Centre for Addiction and Mental Health at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 14 to 35 years
What is being tested?
NAVIGATE and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesCanada
Study dates
3 Jan 2020to 23 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • North Bay Regional Health Centre

    North Bay, Ontario, P1B 0A4

  • Durham Amaze- Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • Niagara Region Public Health

    Thorold, Ontario, L2V 4Y6

  • First Place Clinic and Regional Resource Centre

    Thunder Bay, Ontario, P7A4K9

  • CMHA Waterloo Wellington

    Waterloo, Ontario, N2J 4M1

Other trials in Canada

About this study

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

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.
Read the detailed description

The emergence of early psychosis intervention (EPI) programs has provided tremendous hope for individuals experiencing psychosis by providing early intervention. Work by the team shows that youth who access an EPI program in Ontario, Canada receive faster psychiatric follow-up, better coordination of care between inpatient and outpatient services, reduced burden on the emergency department, and reduced all-cause mortality. The team's system-level data support EPI programs as a critical life-saving intervention. Internationally, EPI has demonstrated significant benefits compared to treatment as usual with respect to engagement, service utilization, and suicide.

Despite the initial life-saving benefits of EPI services, provincial, national and international data show that consistent delivery of high-quality, evidence-based care in EPI programs is a major challenge. Recovery rates in EPI programs remain low, and associated disability has not improved under routine clinical care. One explanation for these disappointing facts is that a low proportion of patients receive recovery-based services, namely, case management including individualized psychosocial interventions, family education and intervention, and supported education and employment. Even in clinical service delivery trials, recovery-based service is received by 15-56% of patients, with only 18% receiving comprehensive EPI services. While EPI standards across jurisdictions recommend coordinated and comprehensive recovery-based care, effective implementation and sustainability of such care in real-world settings remains poor.

The team's work in Ontario has uncovered a startling gap between the evidence-based standard of care, and real-world delivery of care, even in a jurisdiction (Ontario) that has prioritized EPI services. The results of the team's Ontario survey were mirrored in a national survey of 11 Canadian EPI programs. This study is designed to improve the delivery of recovery-oriented evidence-based EPI care in Ontario, and improve person-, system-, and economic-level outcomes for youth and emerging adults (YEA) suffering from a first episode psychosis (FEP), offering a potential roadmap for the rest of Canada.

In 2004, the province of Ontario allocated funding for EPI programs based on early evidence of efficacy. Between 2005 and 2007, this funding led to a major EPI program expansion in Ontario, but the absence of provincial standards led to program development in an ad-hoc manner, drawing upon general service delivery experience and advice from established programmes. Concomitantly, the Early Psychosis Intervention Ontario Network (EPION) was established, which has now grown to 52 EPI sites. The establishment of EPI program standards in Ontario in 2011, informed by existing international and national standards, but also by input from clinicians, patients, family-members, and policy makers was a crucial first step toward standardizing care. However, the release of standards alone is not sufficient to ensure effective implementation, practice change, and ongoing quality practice.

Key findings from the first survey by the Ontario Standards Implementation Steering Committee (SISC) of 52 EPI program sites in Ontario (92% participation) demonstrated important challenges in delivering evidence-based EPI care. A follow-up survey also identified opportunities for addressing these challenges. Building on the two surveys, the investigators conducted a study to measure fidelity to current EPI standards using the First Episode Psychosis Service - Fidelity Scale. The most notable finding was lack of delivery of consistent recovery-oriented care, with no structured or manualized process for these elements of care. Through site visits, and in-person interviews with nine Ontario EPI programs, the investigators obtained a richer and clearer picture of the current state, creating an opportunity to implement solutions that can address the major challenges identified in the fidelity study.

The investigators want to address these challenges in Ontario EPI settings by implementing NAVIGATE, a coordinated and comprehensive multidisciplinary treatment program for FEP that is deliverable in community mental health settings. NAVIGATE is manualized and measurement-based. To maximize affordability, adaptability, spread, and sustainability, the investigators will utilize the already-established EPION community of practice, the implementation science expertise of PSSP (Provincial System Support Program), and the sustainability and capacity building approach of The Extension of Community Health Outcomes (ECHO) Ontario Mental Health at CAMH and the University of Toronto (ECHO-ONMH).

NAVIGATE was developed in consultation with clinical and research experts, biostatisticians, health economists, consumers, family members, advocacy groups, and government officials. It is a form of coordinated specialty care for FEP consisting of 4 key intervention components: (i) individualized medication management using a decision support tool, (ii) a package of psychoeducation and a blend of evidence-based psychotherapies called "individual resiliency training" (IRT); (iii) supported employment and education (SEE); and (iv) a family education program. NAVIGATE was evaluated from 2009-2014 in a cluster randomized controlled trial involving 404 individuals with an FEP in 34 community mental health centers across the United States. Notably, it was delivered by re-allocating existing community mental health resources with no new funding for clinical care. Compared to usual care, NAVIGATE treatment provided greater improvement in symptoms, but more importantly, as prioritized by patients, significantly greater improvement in real-world functioning, including social functioning and engagement in educational and vocational training. NAVIGATE was also readily implementable across a broad range of community-based mental health settings, with enhanced engagement and delivery of multidisciplinary care to YEA presenting with psychosis and their families compared to standard care, and with longer and more consistent receipt of mental health services. A recent economic analysis revealed that NAVIGATE treatment was more cost-effective compared to standard community care, driven by the anticipated enhanced health benefits and improvements in quality of life. NAVIGATE implementation addresses the major challenges identified in the previously mentioned SISC fidelity study, as follows:

Challenge 1: NAVIGATE operationalizes current EPI standards using manualized protocols, ensuring consistency and reducing variability in care. The four NAVIGATE components (individualized medication management, IRT, SEE, and family education program) are systematically applied in collaboration with the patient. There is an overarching emphasis on the coordinated delivery of these elements of care. Every patient is offered these elements of care, and modules are completed in a systematic time-oriented fashion that reduces variability in care among sites and team-members within a site. At each patient visit, a contact/progress note is completed, including the modules delivered, that the team reviews to assess patient progress, fidelity, and determine need for adjustments.

Challenge 2. Ontario EPI sites have learned about NAVIGATE through didactic sessions and conferences offered through EPION. Because translation and implementation of evidence-based practice remains a challenge, training, implementation expertise, and other resources are required. The mandate of the CAMH PSSP is to support system change in Ontario by providing implementation, evaluation, knowledge exchange, engagement and information management expertise to organizations and networks across the province. PSSP operates regional offices throughout Ontario and their implementation teams work closely with local communities and key partners to implement and sustain system improvements. For this project, regional PSSP teams will support implementation and work closely with NAVIGATE content experts from the Slaight Centre (CAMH's EPI program), and community site leads, who are members of EPION.

Challenge 3. EPION has identified use of technology to transfer knowledge, and equitable application of the provincial standards as key priorities. ECHO consists of specialist hubs that connect with multiple learner teams in remote areas through televideo-conferencing technology, and thus can bridge the geographic gap required to bolster the Ontario EPI community of practice. The goal of ECHO clinics is to extend the reach of best practices in academic settings to the chronic and complex illnesses seen in local settings, thereby reducing variation, increasing access to specialist mentoring and services, and monitoring and improving patient outcomes. Initial evaluation data in Ontario has shown high provider satisfaction and engagement with ECHO, and increased knowledge and self-efficacy in managing mental health and addictions in rural and remote settings.

How is this Study Further Enhanced?

  1. This project includes Patient and Family Engagement. In the direct planning and design of the present study, one of the team's Principal Investigators with lived experience was present at each team meeting, and was an equal partner in decisions regarding all of the outcome measures. A co-applicant family member (her son experienced an FEP) also joined the team, and she provided input, further refining the research objectives. The Advisory Committees will grow to include patient/family representation from each site, and will provide ongoing guidance to the research team in implementation, evaluation, analyses, and dissemination. The investigators will also continue qualitative work with patients and families to further evaluate NAVIGATE at the participating sites. ii) Using data from ICES, which captures all physician and hospital-provided insured services in Ontario, the investigators will compare population-based outcomes (hospitalizations, emergency department visits, suicide attempts and mortality) with two comparison groups: 1) all EPI program FEP patients who have not been part of the NAVIGATE trial; and 2) all FEP patients who are not attached to EPI programs. All EPI programs in Ontario report their service utilization data through the Ontario Common Assessment of Need (OCAN) dataset (OCAN is linked to ICES data). The investigators can accurately ascertain the initiation date of all EPI patients by sex within Ontario through ICES linkage. The ability to link NAVIGATE's primary clinical and implementation data with ICES data, and the capacity to identify all FEP patients in Ontario (whether treated in EPI programs or not) allows for a meaningful, valid, and highly generalizable comparison of outcomes. The use of propensity score methods will address confounding associated with observational studies, and mimics some of the characteristics of a randomized controlled trial.

Primary Study Hypotheses:

  1. Following the implementation of NAVIGATE, program fidelity to the Ontario EPI 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 ED visits, fewer suicide attempts, lower mortality, and lower costs.
  3. Improvements in functioning and symptoms will be comparable to the RAISE study; 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.
Being tested
NAVIGATE, Treatment as Usual
Keywords
Implementation Science, Youth and Emerging Adults, First Episode Psychosis, Schizophrenia, Mental Health, Psychiatric Services, NAVIGATE
Medical subject headings
Schizophrenia, Childhood, Psychotic Disorders, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Affective Disorders, Psychotic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAVIGATEBehavioural

    NAVIGATE was developed in consultation with clinical and research experts, biostatisticians, health economists, consumers, family members, advocacy groups, and government officials. It is a form of coordinated specialty care for first episode psychosis consisting of 4 key intervention components:

    1. individualized medication management using a decision support tool;
    2. a package of psychoeducation and a blend of evidence-based psychotherapies called "individual resiliency training" (IRT);
    3. supported employment and education (SEE);
    4. a family education program

  • Treatment as UsualBehavioural

    Received standard Ontario EPI clinical services.

Study groups in NCT03919760
Study groupRoleWhat they receive
NAVIGATE EPIExperimentalThis group of first episode psychosis patients is receiving NAVIGATE early psychosis intervention (EPI) as their regular clinical standard of care. The project team is implementing NAVIGATE at several early psychosis intervention (EPI) programs in different geographic regions of Ontario. The team will recruit consecutive referrals to these programs in order to determine longitudinal change in functioning and symptoms (hypothesis #3). Additionally, the primary data collected for these patients will be linked deterministically to data sources held at the Institute for Clinical Evaluative Sciences (ICES) via their unique health card number. Routine system-level outcome measurements will be compared among NAVIGATE subjects and two control populations (hypothesis #2 - see other groups/cohorts).
Receives: Behavioral: NAVIGATE
Non-NAVIGATE EPIActive comparatorThis group of first episode psychosis patients received early psychosis intervention other than NAVIGATE as their regular clinical standard of care. The data already collected for these patients (not as a part of study/recruitment) is held at the Institute for Clinical Evaluative Sciences (ICES). Routine system-level outcome measurements will be compared among NAVIGATE subjects and two control populations (hypothesis #2 - see other groups/cohorts).
Receives: Behavioral: Treatment as Usual
Non-EPINo interventionThis group of first episode psychosis patients did not receive early psychosis intervention as their regular clinical standard of care. The data already collected for these patients (not as a part of study/recruitment) is held at the Institute for Clinical Evaluative Sciences (ICES). Routine system-level outcome measurements will be compared among NAVIGATE subjects and two control populations (hypothesis #2 - see other groups/cohorts).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypothesis 1: Fidelity/Adaptability

    First Episode Psychosis Service-Fidelity Scale (FEPS-FS) will be used to assess fidelity of service delivery to the current standard of early psychosis intervention in relation to 32 program-specific items (individual and team practices) on a 5-point scale from "1=not implemented" to "5=fully implemented". Ratings for each site will be made through a remote assessment process that includes a review of site administrative data, data abstracted from client health records, and phone interviews with site staff.

    Site will be the unit of analysis. Descriptive statistics (percentages, means, medians, range) will be reported for the total scale score and for subscale scores that align with NAVIGATE components. Fidelity scores will be calculated per site in relation to the four core NAVIGATE interventions using measurements of service utilization. Total and subscale scores will be an average of item scores, reported out of 5.

    Measured: Exploration stage of implementation [approx. year 1], following implementation [approx. year 2] and end of study [approx. year 4]

  2. Hypothesis 1: Penetration/Scalability

    To determine whether implementation of NAVIGATE is associated with improvement in fidelity to the EPI standard, program staff will document delivery of core modules for each of the four interventions. We will calculate the percentage of core modules completed per intervention per patient to assess penetration and to identify variations in delivery both within sites and across sites. Additionally, we will calculate frequency of team activities (e.g., weekly meetings, direct supervision) and assess staff perceived competence in delivery of NAVIGATE using the Readiness Monitoring Tool and the competency assessment questionnaires completed at the conclusion of each ECHO cycle.

    Measured: End of study [approx. year 4]

  3. Hypothesis 1: Contextual Factors

    The Consolidated Framework for Implementation Research (CFIR) will be used to systematically assess contextual factors that are associated with effective implementation. The CFIR constructs are organized within five major domains: intervention characteristics (e.g., complexity, relative advantage); outer setting (e.g., external policy, patient needs); inner setting (e.g., resources, fit, leadership); staff characteristics (e.g., knowledge, beliefs); and implementation process (e.g., facilitation, planning, coaching). The CFIR will be used to develop a semi-structured interview to guide data collection. Interviews will be conducted with stakeholders at each site (EPI staff, organization leaders) at the end of the study, recorded, and transcribed.

    Measured: End of study [approx. year 4]

  4. Hypothesis 1: Sustainability

    Staff attendance during ECHO sessions will indicate ECHO engagement and retention.

    Measured: Ongoing throughout study [years 2-4 inclusive]

  5. Hypothesis 1: Sustainability

    A competency assessment questionnaire will be administered to staff to assess changes in attitudes, knowledge and self-efficacy (self-reported competence) in delivering NAVIGATE components.

    Question domains will include Likert scales assessing self-reported knowledge and skill domains specific to the NAVIGATE model. Self-efficacy questions will focus on key competency domains of NAVIGATE and assess confidence in delivering these components in their local settings.

    Measured: Prior to ECHO participation [approx. year 2] and end of study [approx. year 4]

  6. Hypothesis 1: Affordability

    The investigators will employ a costing algorithm developed in SAS®, and available at ICES, to estimate all direct patient-level health care costs incurred by the public third-party payer (Ontario Ministry of Health and Long-Term Care) across the three comparison groups. Included will be costs of hospitalizations (both non-psychiatric and psychiatric); ED visits; physician services (i.e. primary care, psychiatry and other care) and diagnostics tests; outpatient prescription drugs for individuals covered under the provincial public drug insurance plan only (for individuals under 65 who receive social assistance and for individuals under age 25 who lack private insurance coverage); home care; and other care (this includes other ambulatory care, such as same-day surgery/procedures, cancer and dialysis clinic visits, and other hospital-based care, such as rehabilitation and complex continuing care).

    Measured: End of study [approx. year 4]

  7. Hypothesis 2: System-Level: Number of psychiatric hospitalization days in the year following NAVIGATE admission

    Propensity scores will be used to compare NAVIGATE participants with 2 groups: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment.

    The primary outcome is days in hospital (psychiatric hospitalizations) in the year following NAVIGATE admission.

    Measured: End of study [approx. year 4]

  8. Hypothesis 2: System-Level: Time to first psychiatric hospitalization

    Propensity scores will be used to compare NAVIGATE participants with 2 comparison groups: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment.

    Hospitalization-based outcomes assessed include time to first psychiatric hospitalization.

    Measured: End of study [approx. year 4]

  9. Hypothesis 3: Assessment for diagnosis

    Psychiatric diagnosis/diagnoses will be confirmed using the Structured Clinical Interview for DSM-5 (SCID-5). Information from the SCID-5 will be supplemented by information from family informants, any previous psychiatrist, and medical records.

    Measured: Admission to clinic [month 0, 12, 24]

  10. Hypothesis 3: Assessment of clinical psychopathology [BPRS]

    The Brief Psychiatric Rating Scale (BPRS) (24 item) will be used to assess the severity of positive symptoms, psychosis, negative symptoms, and general psychopathology. Scores range from 2-7 for each item (7 indicates worse symptoms). Total score is a sum ranging from 48-168.

    Measured: Admission to clinic [months 0, 6, 12, 18, 24]

  11. Hypothesis 3: Assessment of clinical psychopathology [PHQ-9]

    The self-report Patient Health Questionnaire - 9 (PHQ-9) will be used to characterize the presence and severity of depressive symptoms. Higher score = worse symptoms (range 0-27).

    Measured: Admission to clinic [month 0, 6, 12, 18, 24]

  12. Hypothesis 3: Assessment of clinical psychopathology [QLS]

    The Intrinsic Motivation Factor of the Quality of Life Scale (QLS) will serve as a specific measure of motivation to augment the above psychopathology measures. Semi-structured interview (subscale item) score range 0-6 (higher score = higher intrinsic motivation).

    Measured: Admission to clinic [month 0, 6, 12, 18, 24]

  13. Hypothesis 3: Assessment of illness severity and improvement

    The Clinical Global Impressions Scale (CGI) will be administered to characterize overall illness severity. It rates both illness severity and improvement. It takes into account all available information, including knowledge of the patient's history, psychological circumstances, symptoms, behaviour, and the impact of the symptoms on the patient's ability to function. Structured interview, illness and improvement score range 0-7 (higher = worse severity/least improvement).

    Measured: Admission to clinic [month 0, 6, 12, 18, 24]

  14. Hypothesis 3: Assessment of functioning [WHODAS 2.0]

    WHO Disability Assessment Schedule 2.0: assessment of functioning to provide an assessment of health and disability. Scoring will be done using item-response theory. It takes the coding for each item response as "none", "mild", "moderate", "severe" and "extreme" separately, and then uses an algorithm to determine the summary score by differentially weighting the items and the levels of severity. Domain and total scores will be produced (total score range 0 to 100, where 0 = no disability; 100 = full disability).

    Measured: Admission to clinic [month 0, 6, 12, 18, 24]

  15. Hypothesis 3: Assessment of parental socio-economic status

    Parental and participant education will be used as indicator of SES.

    Measured: Admission to clinic [month 0]

  16. Hypothesis 3: Measurement of Service Utilization

    The Service Use and Resource Form (SURF) will be used to measure utilization of mental health and other medical services across residential, inpatient, and outpatient treatment settings. This will be administered by research staff either over the phone or via email survey, based on participant preference.

    Measured: Month 6, 12, 18, 24

  17. Hypothesis 4: Engagement

    The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. Semi-structured interviews will be conducted with patients, families, and NAVIGATE staff members.

    Measured: End of implementation [approx. year 2], Study end [approx. year 4]

  18. Hypothesis 4: Engagement [PPEET/PCORI]

    The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. A modified (simplified/combined) PPEET (Public and Patient Engagement Evaluation Tool) \& PCORI engagement activity inventory will be administered to Youth and Family Advisory Members.

    Measured: After the first engagement [approx. year 1]. end of implementation [approx. year 2]

  19. Hypothesis 4: Engagement [Interview]

    The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. A semi-structured interview will be conducted with Youth and Family Advisory Members.

    Measured: After first engagement [approx. year 1], End of the implementation [approx. year 2], study end [approx. year 4]

Secondary outcomes (2)

  1. Hypothesis 2: System-Level: Emergency Department Visits and Suicide Attempts

    Each NAVIGATE subject will be matched to two types of subjects: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment.

    Investigators will measure psychiatric emergency department visits with a year of admission as well as ED visits for suicide attempts. Visits to psychiatrists and primary care physicians will also be counted. Visits to primary care physicians will be stratified as mental health related versus non-mental health related based on a previously validated algorithm.

    Measured: End of study [approx. year 4]

  2. Hypothesis 3: Demographics

    A demographic questionnaire will be administered. Example items include participant sex, gender, education, employment, financial support, ethnicity, race, language, legal system involvement, housing situation, and sibling and parent information.

    Measured: Admission to clinic [month 0]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start3 Jan 2020
  3. Primary completion23 Dec 2024
  4. Study completion23 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Model description
We will recruit participants from 6 EPI programs across various geographic regions in Ontario. Recruitment will be gradually phased in, after which time sites will proceed with full recruitment.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03919760
Sponsor's protocol ID
MY9-158586
Acronym
EPI-SET
Status last verified
Feb 2025
First submitted
19 Mar 2019
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data (other than that held by ICES, which is not permitted to be shared) will be available by request to the lead principal investigator and managed by a publications committee, provided the project has Research Ethics Board approval. Investigators who are not project collaborators may require a data sharing agreement with CAMH based on institutional policies.

Publications

  • McGlashan TH. Early detection and intervention of schizophrenia: rationale and research. Br J Psychiatry Suppl. 1998;172(33):3-6.

    PubMed 9764119

  • Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.

    PubMed 9764127

  • Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.

    PubMed 10842426

  • Schoenbaum M, Sutherland JM, Chappel A, Azrin S, Goldstein AB, Rupp A, Heinssen RK. Twelve-Month Health Care Use and Mortality in Commercially Insured Young People With Incident Psychosis in the United States. Schizophr Bull. 2017 Oct 21;43(6):1262-1272. doi: 10.1093/schbul/sbx009.

    PubMed 28398566

  • Gatov E, Rosella L, Chiu M, Kurdyak PA. Trends in standardized mortality among individuals with schizophrenia, 1993-2012: a population-based, repeated cross-sectional study. CMAJ. 2017 Sep 18;189(37):E1177-E1187. doi: 10.1503/cmaj.161351.

    PubMed 28923795

  • Correll CU, Solmi M, Veronese N, Bortolato B, Rosson S, Santonastaso P, Thapa-Chhetri N, Fornaro M, Gallicchio D, Collantoni E, Pigato G, Favaro A, Monaco F, Kohler C, Vancampfort D, Ward PB, Gaughran F, Carvalho AF, Stubbs B. Prevalence, incidence and mortality from cardiovascular disease in patients with pooled and specific severe mental illness: a large-scale meta-analysis of 3,211,768 patients and 113,383,368 controls. World Psychiatry. 2017 Jun;16(2):163-180. doi: 10.1002/wps.20420.

    PubMed 28498599

  • Hjorthoj C, Sturup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22.

    PubMed 28237639

  • Craig TK, Garety P, Power P, Rahaman N, Colbert S, Fornells-Ambrojo M, Dunn G. The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis. BMJ. 2004 Nov 6;329(7474):1067. doi: 10.1136/bmj.38246.594873.7C. Epub 2004 Oct 14.

    PubMed 15485934

  • Kuipers E, Holloway F, Rabe-Hesketh S, Tennakoon L; Croydon Outreach and Assertive Support Team (COAST). An RCT of early intervention in psychosis: Croydon Outreach and Assertive Support Team (COAST). Soc Psychiatry Psychiatr Epidemiol. 2004 May;39(5):358-63. doi: 10.1007/s00127-004-0754-4.

    PubMed 15133591

  • Grawe RW, Falloon IR, Widen JH, Skogvoll E. Two years of continued early treatment for recent-onset schizophrenia: a randomised controlled study. Acta Psychiatr Scand. 2006 Nov;114(5):328-36. doi: 10.1111/j.1600-0447.2006.00799.x.

    PubMed 17022792

  • Anderson KK, Norman R, MacDougall A, Edwards J, Palaniyappan L, Lau C, Kurdyak P. Effectiveness of Early Psychosis Intervention: Comparison of Service Users and Nonusers in Population-Based Health Administrative Data. Am J Psychiatry. 2018 May 1;175(5):443-452. doi: 10.1176/appi.ajp.2017.17050480. Epub 2018 Mar 2.

    PubMed 29495897

  • Petersen L, Jeppesen P, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen P, Nordentoft M. A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ. 2005 Sep 17;331(7517):602. doi: 10.1136/bmj.38565.415000.E01. Epub 2005 Sep 2.

    PubMed 16141449

  • Malla A, Schmitz N, Norman R, Archie S, Windell D, Roy P, Zipursky RB. A multisite Canadian study of outcome of first-episode psychosis treated in publicly funded early intervention services. Can J Psychiatry. 2007 Sep;52(9):563-71. doi: 10.1177/070674370705200904.

    PubMed 17953160

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Questions about this trial

What is this clinical trial studying?

A study testing NAVIGATE and Treatment as Usual in people with First Episode Psychosis and Schizophrenia, Childhood, run by Centre for Addiction and Mental Health at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypothesis 1: Fidelity/Adaptability (time frame: Exploration stage of implementation [approx. year 1], following implementation [approx. year 2] and end of study [approx. year 4]). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03919760, which also lists 73 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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