Designing a Mental Health Model for Latina Women

• ClinicalTrials.gov Identifier: NCT03901430
• Recruitment Status: Unknown
• First Posted: April 3, 2019
• Last Update Posted: April 26, 2019
• Sponsor: University of New Mexico
• Information provided by (Responsible Party): University of New Mexico

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Mental Health Wellness 1; Depression	Behavioral: Group navigation model	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Participants are given ID numbers and all data is coded with ID number
• Primary Purpose: Supportive Care
• Official Title: Designing a Culturally Appropriate Group Navigation Model to Improve Mental and Emotional Health Equity for Spanish-Speaking Latina Women
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: March 30, 2019
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: Class; Group navigation model

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.

Outcome Measures

Primary Outcome Measures :

1. Depression [ Time Frame: 6 months ]
   Patient Health Questionnaire-9 (PHQ-9) administered to monitor if intervention changes depression score

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• female over 18 Spanish-speaking economically disadvantaged

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Julia M Hess, Ph.D.; 5052724462; jmhess@salud.unm.edu

Contact: Janet Page-Reeves, Ph.D.; 505-306-3041; jpage-reeves@salud.unm.edu

Locations

United States, New Mexico

University of New Mexico; Recruiting

Albuquerque, New Mexico, United States, 87131

Contact: Julia M Hess 505-272-4462 jmhess@salud.unm.edu

Sponsors and Collaborators

University of New Mexico

More Information

• Responsible Party: University of New Mexico
• ClinicalTrials.gov Identifier: NCT03901430
• Other Study ID Numbers: 18-305
• First Posted: April 3, 2019
• Last Update Posted: April 26, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms