First Episode PsychosisReduceDUPNCT03102151
Reducing the Duration of Untreated Psychosis
An observational study of First Episode Psychosis, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Community Campaign La CLAVE
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 30 Aug 2019
- Phase
- Observational
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Living in the catchment area of San Fernando Mental Health Outpatient clinic, a clinic with the Los Angeles County Department of Mental Health
Who may be able to join
- Meet Diagnostic and Statistical Manual-4 criteria for a psychotic disorder
- of Latino origin
Who cannot join
- has a neurological disorder or suffers from brain trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
San Fernando Mental Health Center
Granada Hills, California, 91344
About this study
Official title: Reducing the Duration of Untreated Psychosis Through Community Education
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.
Read the detailed 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.
- Conditions
- First Episode Psychosis
- Being tested
- Community Campaign La CLAVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Campaign La CLAVEOther
A community campaign to teach community residents and professional networks the signs and symptoms of psychosis using social media, community talks, and advertising.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of recruitment into the study
Secondary outcomes (1)
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).
Measured: At the time of recruitment in to study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study startMay 2014
- Primary completion31 Dec 2018
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode PsychosisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven R. Lopez, University of Southern California
- Investigators
- Steven Lopez, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102151
- Sponsor's protocol ID
- USCLaCLAVE
- Other IDs
- 1R01MH103830
- Acronym
- ReduceDUP
- Status last verified
- Jan 2023
- First submitted
- 1 Aug 2016
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Duration of Untreated Psychosis Through Community Education
- ClinicalTrials.gov ID
- NCT03102151
- Acronym / sponsor ID
- ReduceDUP / USCLaCLAVE
- Conditions
- First Episode Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- May 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Living in the catchment area of San Fernando Mental Health Outpatient clinic, a clinic with the Los Angeles County Department of Mental Health
Key inclusion criteria (2 listed)
- Meet Diagnostic and Statistical Manual-4 criteria for a psychotic disorder
- of Latino origin
Key exclusion criteria (1 listed)
- has a neurological disorder or suffers from brain trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Campaign La CLAVEA community campaign to teach community residents and professional networks the signs and symptoms of psychosis using social media, community talks, and advertising. | Other | – |
Primary outcome
Latency to Treatment (LTT) a novel interview based assessment tool to measure the Duration of Untreated Psychosis
Time frame: At the time of recruitment into the study
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.
1 secondary outcome
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?)
Time frame: At the time of recruitment in to study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Lopez, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Episode Psychosis, run by University of Southern California at 1 site in United States.
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 2 inclusion and 1 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Latency to Treatment (LTT) a novel interview based assessment tool to measure the Duration of Untreated Psychosis (time frame: At the time of recruitment into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.