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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03649776
Other study ID # 7224
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 27, 2016
Est. completion date June 30, 2022

Study information

Verified date March 2021
Source Research Foundation for Mental Hygiene, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 324
Est. completion date June 30, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Semi structured Interviews at 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
Primary 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
3 months
Secondary 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.
3 months
Secondary 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
3 months
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