Help-Seeking BehaviorNCT03631745
Delivering Church-based Interventions to Reduce Stigma and Mental Health Treatment Disparities Among Latinos
A study testing NAMI Mental Health 101 and NAMI FaithNet in people with Help-Seeking Behavior and Stigma, Social, run by RAND at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Help-Seeking Behavior, Stigma, Social
- What is being tested?
- NAMI Mental Health 101 and NAMI FaithNet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,713 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Congregant of selected intervention and control churches
Who cannot join
- Does not meet criteria above
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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).
- Conditions
- Help-Seeking Behavior, Stigma, Social
- Being tested
- NAMI Mental Health 101 and NAMI FaithNet
- Keywords
- mental health literacy, stigma, help-seeking, Latino, faith-based, religious congregations, contact-based interventions
- Medical subject headings
- Help-Seeking Behavior, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAMI Mental Health 101 and NAMI FaithNetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NAMI Mental Health 101 and NAMI FaithNet | Experimental | Mental Health 101 and FaithNet Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mental Health Service Use between Baseline and 12-month Follow-up
Secondary outcomes (1)
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.
Measured: Mental Illness Stigma reduction between Baseline and 12-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start9 Feb 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Help-Seeking BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,713 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance on Mental Illness California
- Responsible party
- Principal investigator, Eunice Wong, RAND
- Investigators
- Eunice C Wong, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631745
- Sponsor's protocol ID
- R01MD012638
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2018
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41282142
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Church-based Interventions to Reduce Stigma and Mental Health Treatment Disparities Among Latinos
- ClinicalTrials.gov ID
- NCT03631745
- Acronym / sponsor ID
- R01MD012638
- Conditions
- Help-Seeking Behavior, Stigma, Social
- Keywords
- mental health literacy, stigma, help-seeking, Latino, faith-based, religious congregations, contact-based interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,713 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Alliance on Mental Illness California
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NAMI Mental Health 101 and NAMI FaithNet | Experimental | Behavioral: NAMI Mental Health 101 and NAMI FaithNetMental Health 101 and 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Congregant of selected intervention and control churches
Key exclusion criteria (1 listed)
- Does not meet criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAMI Mental Health 101 and NAMI FaithNetCongregants 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. | Behavioural | NAMI Mental Health 101 and NAMI FaithNet |
Primary outcome
Mental Health Service Use
Time frame: Mental Health Service Use between Baseline and 12-month Follow-up
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.
1 secondary outcome
Mental Illness Stigma
Time frame: Mental Illness Stigma reduction between Baseline and 12-month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 41282142Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunice C Wong principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAMI Mental Health 101 and NAMI FaithNet in people with Help-Seeking Behavior and Stigma, Social, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Service Use (time frame: Mental Health Service Use between Baseline and 12-month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.