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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03102151
Other study ID # USCLaCLAVE
Secondary ID 1R01MH103830
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date August 30, 2019

Study information

Verified date January 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study examines the possible effect of a community campaign to decrease the duration of untreated psychosis in persons with their first episode of a psychotic disorder.


Description:

The study examines whether a community campaign can reduce over time the duration of untreated psychosis (DUP) among persons with first episode psychosis (FEP). The DUP of mental health patients with FEP who sought services at a public outpatient or an inpatient facility was assessed for a 15 month period prior to the campaign launch. This serves as the baseline or historical control. The DUP will continue to be assessed for another 3 years. The hypothesis being tested is that there will be a significant decrease in DUP between baseline, one-year, two-year and three-year follow-ups. This study is being carried out with Latinos in Los Angeles County because as a group, particularly among Spanish-speaking immigrants, Latinos are at high risk for prolonged DUP.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date August 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: - Meet Diagnostic and Statistical Manual-4 criteria for a psychotic disorder - of Latino origin Exclusion Criteria: - has a neurological disorder or suffers from brain trauma

Study Design


Intervention

Other:
Community Campaign La CLAVE
A community campaign to teach community residents and professional networks the signs and symptoms of psychosis using social media, community talks, and advertising.

Locations

Country Name City State
United States San Fernando Mental Health Center Granada Hills California

Sponsors (3)

Lead Sponsor Collaborator
University of Southern California National Institute of Mental Health (NIMH), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Latency to Treatment (LTT) a novel interview based assessment tool to measure the Duration of Untreated Psychosis The time from the onset of psychosis to the time the subject receives appropriate mental health treatment. The metric is number of weeks that the person went without treatment from illness onset. The number of weeks is the variable of interest that will be aggregated. At the time of recruitment into the study
Secondary Psychosis literacy, a questionnaire based inquiry for which the respondents answer either open-ended questions (e.g., What is serious mental Illness?) or "Yes-no" questions ("e.g., Can you recognize a serious mental illness in others?) The responses to the interview are either written down or audio-recorded. Raters then listen or read the responses and code them. The responses are aggregated as frequencies (e.g., the number of symptoms identified) or as percentages (e.g., the proportion of respondents who reported that they can recognize a serious mental illness in others). At the time of recruitment in to study
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