On Track Chile For First Episode Psychosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Psychosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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).Masking: Single (Outcomes Assessor)Masking Description: 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.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 15 years and 35 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04247711
- Collaborators
- University of O'Higgins
- Columbia University
- Washington University School of Medicine
- New York University
- Research Foundation for Mental Hygiene, Inc.
- New York State Psychiatric Institute
- Investigators
- Principal Investigator: Ruben Alvarado, MD PhD University of Chile
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