- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03649776
Training Church Leaders in Mental Health First Aid
Training Community Members in Mental Health First Aid
The purpose of this study is to train Church Leaders and other community members in Mental Health First Aid (MHFA), which is an evidence-based public mental health education program. MHFA has been found to improve people's recognition of emotional and mental health challenges and to increase people's confidence in providing help to others. Information about MHFA can be accessed at http://www.mentalhealthfirstaid.org.
MHFA consists an 8-hour training program in which participants will be provided a manual, learn the signs and symptoms of common mental health problems, and learn a 5-step action plan to help someone in an emotional crisis.
Participants ware recruited from faith-based organizations (i.e., churches), health care organizations (i.e., hospitals), and other community based organizations. There will be no treatment directly provided as part of this study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This protocol primarily targets African Americans who live in Central Harlem, New York.
Community members will also include church leaders and lay participants from local churches, health care organizations, and other community-based organizations. This will include any adult who meets study eligibility criteria and consents to take the MHFA training at one of our approved study sites. Examples of community study sites are First Corinthian Baptist Church, New York State Psychiatric Institute, and the Columbia University Wellness Center
Description
Inclusion Criteria:
- Fluent in English
- Able to provide signed formed consent
Exclusion Criteria:
- Any circumstances limiting participant's ability to complete the 8-hour training
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Confidence in Providing Help at 3 months
Time Frame: 3 months
|
After reading a clinical vignette that describes a person with either Schizophrenia or Major Depression, participants are asked "How confident do you feel in helping this person?" Possible responses are on a 5-point Likert scale with 1 = Not at all confident and 5 = Extremely confident |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Stigma at 3 months
Time Frame: 3 months
|
Personal and Perceived Stigma Scale. It is a 14-item measure that assesses stigmatizing attitudes. Questions are on a 5-point Likert scale with 1 = Strongly Agree and 5 = Strongly Disagree with scores ranging from 14 to 70. A higher score indicates greater stigma A clinical vignette, describing either a case with Schizophrenia or Major Depression, is presented. Participants are asked questions about social stigma, which assesses what participants' perceptions of people in their community, and personal stigma, which assesses the participants' personal beliefs. |
3 months
|
|
Change from Baseline in Functional Health Status at 3 months
Time Frame: 3 months
|
The Medical Outcomes Study 12-Item Short Form Survey Instrument (SF-12) is a validated functional health status assessment that assesses health status over the preceding 4 weeks. Measures include
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi structured Interviews at 3 months
Time Frame: 3 months
|
Semi-structured interviews are conducted with participants either over the telephone, in-person at their church or at the New York State Psychiatric Institute.
The purpose of the interview is to get examples of how participants utilized the skills in Mental Health First Aid training, what action items they completed, and how the training could be improved for use among other communities
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sidney H Hankerson, MD, MBA, New York State Psychiatric Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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