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Mental Health Wellness 1NCT03901430

Designing a Mental Health Model for Latina Women

A study testing Group navigation model in people with Mental Health Wellness 1 and Depression, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to implement such an approach conceptualized by a community health worker (CHW) to pilot an innovative, multi-level intervention to address social and structural determinants that negatively influence MEH disparities for Latinas from low-income households. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1, Depression
What is being tested?
Group navigation model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
1 Jul 2018to 18 Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • female over 18 Spanish-speaking economically disadvantaged

Who cannot join

  • male under 18 non-Spanish-speaking non-economically disadvantaged

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

Official title: Designing a Culturally Appropriate Group Navigation Model to Improve Mental and Emotional Health Equity for Spanish-Speaking Latina Women

The goal of this study is to implement such an approach conceptualized by a community health worker (CHW) to pilot an innovative, multi-level intervention to address social and structural determinants that negatively influence MEH disparities for Latinas from low-income households. The proposed research integrates CHW navigation with group peer support. Both of these strategies have been shown to be culturally appropriate and effective for improving a variety of health outcomes with this population. Our transdisciplinary, community-engaged team will use a convergent parallel mixed method research design to assess the feasibility of the intervention and its impact on six domains of interest: 1) emotional support, 2) informational support, 3) depression, 4) social isolation, 5) empowerment, and 6) social determinants needs. To prepare for future extramural funding, the investigators will include development of an advocacy plan for multi-level social change impact.

Read the detailed description

Hispanic women (Latinas) experience mental and emotional health (MEH) concerns and disorders that often go unrecognized by health providers, and even when recognized, Latinas have low-levels of treatment follow-through with biomedical modalities. Using a novel community-directed, solution-based approach to increase access to existing services and nurture culturally meaningful social relationships, it is possible to address social determinants of health and reduce these disparities.

The goal of this study is to implement such an approach conceptualized by a community health worker (CHW) to pilot an innovative, multi-level intervention to address social and structural determinants that negatively influence MEH disparities for Latinas from low-income households. The proposed research integrates CHW navigation with group peer support. Both of these strategies have been shown to be culturally appropriate and effective for improving a variety of health outcomes with this population. Our transdisciplinary, community-engaged team will use a convergent parallel mixed method research design to assess the feasibility of the intervention and its impact on six domains of interest: 1) emotional support, 2) informational support, 3) depression, 4) social isolation, 5) empowerment, and 6) social determinants needs. To prepare for future extramural funding, the investigators will include development of an advocacy plan for multi-level social change impact.

Aim 1. Create a group navigation model to improve mental and emotional health equity for Spanish-speaking Latina women. In a series of peer group sessions facilitated by Guadalupe Fuentes, a CHW who designed the model, the investigators will create a culturally-appropriate, non-stigmatizing group intervention. The group process will allow participants to explore their own MEH, better understand the ways that mental health influences well-being and everyday dynamics of their lives, and to develop empowering knowledge and action plans through the support of other women. The investigators will document group discussions, processes, and themes, gather information about women's explanatory models of MEH, and administer a multidimensional survey to capture information about the domains of interest. Through individual case management, Fuentes will work individually with women from the groups to identify their specific social and structural determinants needs, assist them to make an individual action plan, provide them with information about available resources, and help them navigate systems and access resources and services. The investiagtors will document participant needs and navigation outcomes. Hypotheses: Participation will decrease depression, social isolation, and social determinants needs, and increase emotional support, informational support, and women's sense of empowerment.

Aim 2. Create an advocacy plan. With data gathered in group meetings and individual navigation sessions, the investigators will identify social and structural barriers that negatively influence participants' MEH outcomes and ability to access resources and services. The investigators will create an advocacy plan to address structural and policy barriers that can be implemented by CHWs and advocacy groups in the future. Hypotheses: The investigators will be able to identify factors that negatively influence the MEH and well-being of Latinas. They hypothesize that in the future, this knowledge can be used to develop a strategic plan with the potential to address socio-structural and policy barriers through advocacy.

Aim 3. Assess the feasibility of the intervention. The investigators will track recruitment, attrition, attendance at group sessions, and attendance at individual CHW navigation meetings.The investigators will gather survey data and qualitative data to document participant experiences with and perceptions of the group process, working with the CHW, and the value of the intervention. Hypotheses: The intervention pilot will be feasible, acceptable, valuable, and culturally appropriate.

Expected Outcome. This pilot study will use team science to test an intervention that emerged organically in the community and contribute to building the next generation of health disparities research using knowledge generated through solution-based investigation as the foundation for submitting an NIH R21 research proposal.

Being tested
Group navigation model
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group navigation modelBehavioural

    In a series of peer group sessions facilitated by Guadalupe Fuentes, a CHW who designed the model, we will create a culturally-appropriate, non-stigmatizing group intervention. The group process will allow participants to explore their own MEH, better understand the ways that mental health influences well-being and everyday dynamics of their lives, and to develop empowering knowledge and action plans through the support of other women.

Study groups in NCT03901430
Study groupRoleWhat they receive
ClassExperimentalGroup navigation model
Receives: Behavioral: Group navigation model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    Patient Health Questionnaire-9 (PHQ-9) administered to monitor if intervention changes depression score. PHQ-9 total score for the nine items ranges from 0 to 27. Higher scores indicate increased depression. Scores of 5, 10, 15 and 20 represent cutpoints for mild, moderate, moderately severe and severe depression respectively.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start1 Jul 2018
  3. Primary completion18 Mar 2019
  4. Study completion18 Mar 2020

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03901430
Sponsor's protocol ID
18-305
Other IDs
U54MD004811
Status last verified
Apr 2019
First submitted
1 Apr 2019
Last updated
6 Feb 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group navigation model in people with Mental Health Wellness 1 and Depression, run by University of New Mexico 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 6 Feb 2023. 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?

Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Depression (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Feb 2023.

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