On Track Chile For First Episode Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2025-03-30

Brief Summary

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Substantial data support early interventions for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. FEP programs have been widely and successfully implemented in high-income countries. With the partial exception of Chile, however, there is not a single low-and-middle-income country (LMIC) that offers universal access to FEP services. Chile is unique among LMICs in having created a platform for the implementation of FEP services, including 1) an FEP policy that mandates identification of FEP individuals at primary care and delivery of community-based FEP treatments at outpatient mental health clinics, and 2) a public health care system within which this mandate can be fulfilled. Nonetheless, previous research has documented that FEP services provided at mental health clinics do not conform to recently established evidence-based approaches. Therefore, the overarching goal of this proposal is to address the shortfall in evidence-based practices for FEP in Chile by first adapting OnTrackChile (OTCH) from OnTrackNY (OTNY), a coordinated specialty care program for FEP currently being implemented across the US, and then implementing OTCH on a wide scale. Like most FEP programs, OTNY is clinically effective, but unlike most others, it also has a well-established training and technical assistance infrastructure, and a proven track record of being scaled up in large urban areas. To achieve this goal, the Dynamic Adaptation Process will be used to first inform the adaptation and implementation of OTCH in the Chilean context. Then, a Hybrid Trial design will be employed to evaluate the implementation of OTCH as well as its effectiveness and cost in a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OnTrackChile program will be offered in half of these outpatient clinics; usual care services will continue to be offered at the other clinics. Study participants (ages 15 to 35) attending an outpatient clinic assigned to the intervention arm will receive the OTCH coordinated services provided by an interdisciplinary team, based on the interests, needs, and preferences of each study participant. Study participants attending outpatient clinics assigned to "usual care" will receive the usual services offered to people with a wide range of mental health conditions, not just those experiencing first-episode psychosis. The study will engage participants over the course of two years, with interviews to evaluate their experiences at the beginning of their participation, and again after 12 months and 24 months. Over the course of the study, 4-5 mental health providers will also be interviewed at each of the participating clinics (up to 105 additional interviews at the three timepoints). The data collected in this study will help researchers evaluate the effectiveness and cost of FEP treatments based in outpatient clinics and factors which may help or hinder these outcomes.

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Detailed Description

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Conditions

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The 21 participating clinics will be divided into two groups based on poverty level of catchment area and expected enrollment of individuals with FEP for each clinic. The largest site will be matched with two clinics of similar poverty level and clinic size. The matching will be done based on visual inspection of a scatter plot of expected enrollment by income of each site. The nearest neighbor matching approach will be used to choose pairs. Blocks of size 2, and one block of size 3, will be randomly generated. This procedure will entail 1) generating a random number 0 or 1 ten times, and 2) assigning 0 to the Usual FEP care clinic and 1 to the OTCH clinic in each matched pair. For the block of size 3, two sites will be assigned to either OTCH or Usual FEP care, and the remaining site to either OTCH or Usual FEP care as well. The random allocation will enable us to bring into the study one OTCH and one Usual FEP Care clinic per month (except for the block of size 3, as noted above).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

A two-fold strategy will be used to keep the blind. First, external interviewers with experience in conducting clinical evaluations will be hired and trained. These interviewers will be blind to study hypotheses and participant assignment. A mental health professional at each clinic (ie., "Local Coordinator") will do the consent procedures and a member of the Research Staff (ie., "Registration Designee") will randomly assign consented participants to the interviewers. The latter will be blinded to treatment allocation. Second, every assessment will be conducted at a location different from the clinic where a participant receives treatment. This location could be the participant's home, an office in UOH or UCH, or any place in the community where the participant feels comfortable (e.g., a park). This approach was successfully used in a previous U-19 study led by this research team in which most of the follow-up assessments were conducted in participants' neighborhoods.

Study Groups

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OTCH

OTCH is based on OTNY, a Coordinated Specialty Care program for people with first-episode psychosis. The program is implemented by a multidisciplinary team, who provide coordinated, evidence-based services based on the interests, needs, and preferences of each participant.

Group Type EXPERIMENTAL

OTCH

Intervention Type BEHAVIORAL

OTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care.

Usual FEP services

This is generally provided in mental health outpatient clinics which serve a population enrolled in the public health care system.

Group Type PLACEBO_COMPARATOR

Usual FEP Services

Intervention Type BEHAVIORAL

These include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics.

Interventions

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OTCH

OTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care.

Intervention Type BEHAVIORAL

Usual FEP Services

These include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Individuals who have FEP (First Episode Psychosis)
* Individuals who are receiving services at a participating outpatient mental health clinic.
* Individuals who meet ICT-10 criteria for a diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or psychosis not otherwise specified.
* Individuals who have the capacity to provide fully informed consent. (For those under age 18, capacity to provide assent plus informed consent of parent/guardian.)
* Individuals who are able to participate in research assessments in Spanish

Exclusion Criteria

* Individuals who have a non-psychiatric medical condition that impairs functioning.
* Individuals who have a psychosis due solely to another medical condition.
* Individuals who have a psychosis due to a developmental disability.

Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No