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Training Church Leaders in Mental Health First Aid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649776
Recruitment Status : Active, not recruiting
First Posted : August 28, 2018
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Hankerson, MD, MBA, Research Foundation for Mental Hygiene, Inc.

Tracking Information
First Submitted Date July 13, 2018
First Posted Date August 28, 2018
Last Update Posted Date December 23, 2019
Actual Study Start Date February 27, 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 24, 2018)
  • 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.
  • 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
    1. General Health: 5-point Likert scale with 1 = Excellent and 5 = Poor
    2. Physical Functioning: 3-point Likert scale with 1 = Yes, Limited a lot and 3 = No, Not Limited at all
    3. Role limitations resulting from physical health problems: Possible responses are 'Yes' or 'No'
    4. Role limitations resulting from emotional problems: Possible responses are 'Yes' or 'No'
    5. Bodily Pain: 5-point Likert scale with 1 = Not at All and 5 = Extremely
    6. Vitality (energy and fatigue):
    7. Mental Health: 6-point Likert scale with 1 = All of the Time and 6 = None of the Time
    8. 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 24, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Training Church Leaders in Mental Health First Aid
Official Title Training Community Members in Mental Health First Aid
Brief 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. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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

Condition Stigma
Intervention Other: Mental Health First Aid
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 19, 2019)
324
Original Estimated Enrollment
 (submitted: August 24, 2018)
400
Estimated Study Completion Date June 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03649776
Other Study ID Numbers 7224
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sidney Hankerson, MD, MBA, Research Foundation for Mental Hygiene, Inc.
Study Sponsor Research Foundation for Mental Hygiene, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Sidney H Hankerson, MD, MBA New York State Psychiatric Institute
PRS Account Research Foundation for Mental Hygiene, Inc.
Verification Date December 2019