NCT03631745

Brief 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,713

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 9, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

5.9 years

First QC Date

August 2, 2018

Last Update Submit

June 6, 2025

Conditions

Keywords

mental health literacystigmahelp-seekingLatinofaith-basedreligious congregationscontact-based interventions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mental Illness Stigma

    Mental Illness Stigma reduction between Baseline and 12-month Follow-up

Study Arms (2)

NAMI Mental Health 101 and NAMI FaithNet

EXPERIMENTAL

Mental Health 101 and FaithNet

Behavioral: NAMI Mental Health 101 and NAMI FaithNet

Wait-list Control

NO INTERVENTION

After the 12-month follow-up, wait-list control churches will be provided with the opportunity to receive Mental Health 101 and NAMI FaithNet interventions.

Interventions

Congregants of Intervention Churches will receive: 1. NAMI Mental Health 101, a 60-90 minute, contact-based educational intervention 2. 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.

NAMI Mental Health 101 and NAMI FaithNet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Congregant of selected intervention and control churches

You may not qualify if:

  • Does not meet criteria above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAND

Santa Monica, California, 90401, United States

Location

Related Publications (1)

  • Wong EC, Martinez MO, Han B, Seelam R, Derose KP. Cluster-Randomized Trial of a Multilevel Parish-Based Intervention to Improve Mental Health Literacy and Reduce Stigma in Hispanic Communities. Res Sq [Preprint]. 2025 Oct 26:rs.3.rs-7017764. doi: 10.21203/rs.3.rs-7017764/v1.

MeSH Terms

Conditions

Help-Seeking BehaviorSocial Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Eunice C Wong

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The National Alliance on Mental Illness (NAMI) of California has developed Mental Health 101, a suite of contact-based education programs tailored for culturally diverse populations including Latino populations. Another NAMI program, FaithNet, provides resources and training on how churches can shape norms and overcome shame and stigma related to mental illness and treatment. NAMI FaithNet also assists with facilitating linkages to mental health services from providing referrals to partner mental health agencies to forming multi-sector collaboratives of social service organizations, clergy, and mental health providers to create a more holistic, coordinated system of care. The multi-component, church-based, intervention will build on NAMI's existing resources, with tailoring for Latino church-based settings.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Behavioral Scientist

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 15, 2018

Study Start

February 9, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations