StigmaNCT03649776
Training Church Leaders in Mental Health First Aid
An observational study of Stigma, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stigma
- What is being tested?
- Mental Health First Aid
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2016to 30 Jun 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Fluent in English
- Able to provide signed formed consent
Who cannot join
- Any circumstances limiting participant's ability to complete the 8-hour training
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: 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.
- Conditions
- Stigma
- Being tested
- Mental Health First Aid
- Keywords
- Disparities
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health First AidOther
Mental Health First Aid (MHFA) is listed in the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-based Programs and Practices. The program also teaches the common risk factors and warning signs of specific types of illnesses like anxiety, depression, substance use, bipolar disorder, eating disorders, and schizophrenia. Participants are introduced to local mental health resources, national organizations, support groups, and online tools for mental health and addictions treatment and support.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Confidence in Providing Help at 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
Measured: 3 months
Secondary outcomes (2)
Change from Baseline in Stigma at 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.
Measured: 3 months
Change from Baseline in Functional Health Status at 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
- General Health: 5-point Likert scale with 1 = Excellent and 5 = Poor
- Physical Functioning: 3-point Likert scale with 1 = Yes, Limited a lot and 3 = No, Not Limited at all
- Role limitations resulting from physical health problems: Possible responses are 'Yes' or 'No'
- Role limitations resulting from emotional problems: Possible responses are 'Yes' or 'No'
- Bodily Pain: 5-point Likert scale with 1 = Not at All and 5 = Extremely
- Vitality (energy and fatigue):
- Mental Health: 6-point Likert scale with 1 = All of the Time and 6 = None of the Time
- Social Functioning: 6-point Likert scale with 1 = All of the Time and 6 = None of the Time Total Scores range from 0 to 100, with higher scores indicating poorer health
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start27 Feb 2016
- Primary completion31 Dec 2020
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StigmaStudies of the same condition, open and under way.
- 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
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidney Hankerson, MD, MBA, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Sidney H Hankerson, MD, MBA, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649776
- Sponsor's protocol ID
- 7224
- Status last verified
- Mar 2021
- First submitted
- 13 Jul 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Community Members in Mental Health First Aid
- ClinicalTrials.gov ID
- NCT03649776
- Acronym / sponsor ID
- 7224
- Conditions
- Stigma
- Keywords
- Disparities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- 27 Feb 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 Aug 2018 (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 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Fluent in English
- Able to provide signed formed consent
Key exclusion criteria (2 listed)
- Any circumstances limiting participant's ability to complete the 8-hour training
- Inability to provide informed consent
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 |
|---|---|---|
| Mental Health First AidMental Health First Aid (MHFA) is listed in the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-based Programs and Practices. The program also teaches the common risk factors and warning signs of specific types of illnesses like anxiety, depression, substance use, bipolar disorder, eating disorders, and schizophrenia. Participants are introduced to local mental health resources, national organizations, support groups, and online tools for mental health and addictions treatment and support. | Other | – |
Primary outcome
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
2 secondary outcomes
Change from Baseline in Stigma at 3 months
Time frame: 3 months
Change from Baseline in Functional Health Status at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Describes the Mental Health First Aid interventionLink provided by the sponsor.
- Describes the Community Advisory Board created by Dr. Hankerson's NIMH-funded K23 Career Development Award. This Community Advisory Board selected Mental Health First Aid as the study intervention.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sidney H Hankerson, MD, MBA principal investigator
New York State Psychiatric Institute
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 Stigma, run by Research Foundation for Mental Hygiene, Inc. 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 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. 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?
Results are not available in the source record.
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?
Change from Baseline Confidence in Providing Help at 3 months (time frame: 3 months). 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 29 Mar 2021.