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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03631745
Other study ID # R01MD012638
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 9, 2020
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a cluster randomized controlled trial of a Latino church-based intervention in Los Angeles and Riverside Counties. This study aims to leverage the collective resources of Latino religious congregations and the National Alliance on Mental Illness to test the effectiveness of a multi-component intervention directed at reducing stigma, increasing mental health literacy, and improving access to mental health services.


Description:

This study is a cluster randomized controlled trial of a Latino church-based intervention in Los Angeles and Riverside Counties. This study aims to leverage the collective resources of Latino religious congregations and the National Alliance on Mental Illness to test the effectiveness of a multi-component intervention directed at reducing stigma, increasing mental health literacy, and improving access to mental health services. A total of 12 churches (6 intervention and 6 wait-list control) will be enrolled in the study. Churches within each study site, the Riverside County parishes and the Archdiocese of Los Angeles, will be matched in pairs based on size and geography. Three matched pairs from each study site will be randomly selected and then randomly assigned within each pair to intervention or control. The planned study will involve 2400 participants (1200 intervention and 1200 control) who will be part of congregations that are randomly assigned to receive the church-based intervention immediately or a wait list control condition. Participants will be assessed at baseline, 6-month follow-up, and 12-month follow-up to evaluate intervention effects on mental health service use and potential mediators (i.e., mental health literacy, stigma).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1713
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Congregant of selected intervention and control churches Exclusion Criteria: - Does not meet criteria above

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
NAMI Mental Health 101 and NAMI FaithNet
Congregants of Intervention Churches will receive: NAMI Mental Health 101, a 60-90 minute, contact-based educational intervention NAMI FaithNet which consists of congregational support and training to cultivate supportive environments within faith communities for those with mental health conditions and their families.

Locations

Country Name City State
United States RAND Santa Monica California

Sponsors (2)

Lead Sponsor Collaborator
RAND National Alliance on Mental Illness California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mental Health Service Use Change in mental health service use among participants in intervention churches versus those in control churches.
Mental health service use will be measured with the following modified item from the California Health Interview Survey: "In the past 12 months have you seen a professional, such as a counselor, psychiatrist, or social worker for problems with your mental health, emotions, nerves, or your use of alcohol or drugs?"
Response options are dichotomous (Yes/No).
Tran LD, Ponce NA. Who Gets Needed Mental Health Care? Use of Mental Health Services among Adults with Mental Health Need in California. Calif J Health
Promot. 2017;15(1):36-45. PubMed PMID: 28729814; PubMed Central PMCID:
PMC5515380.
Mental Health Service Use between Baseline and 12-month Follow-up
Secondary Mental Illness Stigma Change in stigma among participants in intervention churches versus those in control churches. Personal stigma will be assessed with social distance measures, one of the most widely used indicators of stigma. Social distance is assessed by asking respondents to rate their degree of willingness to interact with someone with a mental illness in various interpersonal situations (e.g., work closely on a job; live next door; spend an evening socializing; marry into the family; as a friend).
Jorm AF, Oh E. Desire for social distance from people with mental disorders. The Australian and New Zealand journal of psychiatry. 2009;43(3):183-200.
Mental Illness Stigma reduction between Baseline and 12-month Follow-up
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