NCT03649776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

4.8 years

First QC Date

July 13, 2018

Last Update Submit

March 26, 2021

Conditions

Keywords

Disparities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from Baseline in Stigma at 3 months

    3 months

  • Change from Baseline in Functional Health Status at 3 months

    3 months

Other Outcomes (1)

  • Semi structured Interviews at 3 months

    3 months

Interventions

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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Fluent in English
  • Able to provide signed formed consent

You may not qualify if:

  • Any circumstances limiting participant's ability to complete the 8-hour training
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Sidney H Hankerson, MD, MBA

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 13, 2018

First Posted

August 28, 2018

Study Start

February 27, 2016

Primary Completion

December 31, 2020

Study Completion

June 30, 2022

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations