Designing a Mental Health Model for Latina Women

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901430
• Other study ID #: 18-305
• Secondary ID: U54MD004811
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 18, 2020

Study information

• Verified date: April 2019
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female over 18 Spanish-speaking economically disadvantaged

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Depression
• Mental Health Wellness 1

Intervention

Behavioral:
• Group navigation model
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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months