Tertulias Social Isolation Women's Groups Study
- Conditions
- Social IsolationDepression
- Registration Number
- NCT04254198
- Lead Sponsor
- University of New Mexico
- Brief Summary
This study will use a multi-level, community-engaged approach to implement "TERTULIAS" ("conversational gatherings" in Spanish). The intervention uses an innovative, culturally and contextually situated peer support group design that was developed by the investigators to improve health outcomes and reduce health disparities for FMI participants in Albuquerque, New Mexico. The study will use a rigorous, transdisciplinary, QUAL⇒QUANT, mixed-method research design. The investigators will document results of the intervention on the primary hypotheses of a decrease in depression, and increases in resilience and social support, as well as on the secondary hypotheses of decreased stress (including the use of innovative testing of hair cortisol as a biomarker for chronic stress), and an increase in social connectedness and positive assessment of knowledge and empowerment gained through the TERTULIAS intervention.
- Detailed Description
Specific Aims. The investigators will conduct a randomized controlled trial with 240 FMIs. Intervention participants will attend a weekly peer group session over 12 months. Control group participants will receive a bimonthly check-in call. All will be surveyed using validated instruments and give hair samples gathered at baseline and 12 months. A subset will be interviewed, and group sessions will be documented. Data will be triangulated using different methods with a QUAL⇒QUAN simultaneous data collection and analysis approach to integrate, converge, and elaborate findings in a way that would not be feasible using only one method.
Aim 1. To measure whether a culturally situated peer group intervention will reduce depression and stress associated with the experience of immigration. Question: Does an intervention design that reproduces culturally important interactions, activities, and constructs lost through immigration result in decreased participant depression and stress? Hypothesis: Incorporating peer-to-peer social interaction, food sharing, and storytelling into the design of a nonclinical peer support group intervention will leverage positive aspects of participant culture and create an experiential context that will (a) decrease participant depression scores by at least 6.5 points more on the Center for Epidemiologic Studies Depression Scale (CES-D) as compared to controls (effect size Cohen's d = 0.43), and (b) lower stress scores in participants more than in controls with d ≥ 0.5 as measured by the Perceived Stress Scale (PSS). The investigators will also assess stress using a cutting-edge biological assessment of hair cortisol as a biomarker for chronic stress.
Aim 2. To test whether an intervention using a "women's funds of knowledge" approach results in improved resilience, knowledge and empowerment. Question: Does an intervention design that encourages participants to share knowledge they developed through life experience and that values this knowledge as a form of expertise nurture protective factors (resilience and knowledge/empowerment) to help FMIs adapt to the immigration context and disrupt the mechanisms that produce health disparities? Hypothesis: Incorporating, valuing and validating women's knowledge and experience in the design of a peer support group intervention will improve participant capacity to adapt to the immigrant context and provide participants with empowering knowledge to deal with new situations. Intervention participants will have higher scores at 12 months and have a larger increase over time as compared to controls (d = 0.5) on the Connor-Davidson Resilience Scale-25 (CD-RISC 25). Knowledge and empowerment will be assessed at 12 months and expect to find high scores with the Trauma-Informed Practice (TIP) Scale (which is designed for post-use).
Aim 3. To investigate whether a culturally situated peer group intervention using a women's funds of knowledge approach can give participants' a sense and experience of social and physical connection ("emplacement") that is lost in the process of immigration. Question: Can the proposed peer support group intervention recreate social and physical connections lost through immigration and strengthen participant social networks? Hypothesis: The peer group will create a culturally appropriate context for establishing interpersonal connections between group members and will give participants a sense of belonging within a social and contextual milieu. At study end, (a) experimental participants will have a marked increase in social support scores v.s. the control group using the Medical Outcomes Study Social Support Survey (MOS SSS) (d ≥ 0.5), and (b) stronger, more dense social connections as described by a social network analysis.
Project Outcomes. This intervention with FMIs will test an innovative intervention to reduce social isolation as a mechanism for reducing depression by leveraging positive cultural dynamics and women's funds of knowledge to nurture social connectedness, knowledge, and resiliency factors in the lives of participants in a transformative way. Generalizability. This trial of TERTULIAS will create a replicable, scalable model for culturally appropriate health promotion with FMIs that has implications for health promotion work with other women from recent and first generation immigrant populations.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 252
- Over age 18
- Female immigrant
- Born in Mexico
- Reports household income under 250% Federal Poverty Level
- Speaks Spanish fluently
- prisoners
- individuals unable to consent
- children
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Depression Baseline, 12 months Comparison of intervention and control participants of their change in depression scores between baseline and 12 months as measured by the summed scores of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Summed scores range from 0 to 100 with higher scores indicating higher levels of depression. Changes will be measured as 12 months - Baseline, so negative change scores indicate decreased depression.
Change in Resilience Baseline, 12 months Comparison of intervention and control participants of their change in resilience scores between baseline and 12 months as measured by the summed scores of the 25-item Connor-Davidson Resilience Scale-25 (CD-RISC 25).Summed scores range from 0 to 100 with higher scores indicating higher levels of resilience. Changes will be measured as 12 months - Baseline, so positive change scores indicate increased resilience.
Change in Social Support Baseline, 12 months Comparison of intervention and control participants of their change in social support scores between baseline and 12 months as measured by the total scaled scores of the 19-item Medical Outcomes Study Social Support Survey (MOS SSS).Total scaled scores range from 0 to 100 with higher scores indicating higher levels of social support. Changes will be measured as 12 months - Baseline, so positive change scores indicated increased social support.
- Secondary Outcome Measures
Name Time Method Knowledge and Empowerment at 12 Months (Intervention arm only) 12 months Knowledge and empowerment will be assessed at 12 months in the intervention arm only using the six subscales of the 33-item Trauma-Informed Practice (TIP) Scale as well as a total score across the subscales. The subscales are Agency (9 items), Information (5 items), Connection (3 items), Strengths (3 items), Inclusivity (8 items), and Parenting (5 items) with each item ranging from 0 (not at all true) to 3 (very true). Descriptive statistics will be reported (means and 95% CIs). Higher scores indicate higher levels of knowledge and empowerment associated with the intervention.
Changes in Social Network Density and Characteristics (Intervention arm only) Baseline, 12 months Results from the following social network analyses (SNA) of the Intervention arm will be "mapped" using UCINET SNA software: 1.) Construct participants' social networks using answers to questions modeled after the General Social Survey. Baseline and 12-month networks will be compared and changes in network density and characteristics will be described. 2.) The level of inclusion of other study participants in individual social networks from baseline to 12 months will be assessed. 3.) Using questions about local resources (e.g., the health insurance exchange, health navigation programs, public food/benefit/clothing programs and charities, free legal assistance programs, low-cost ESL/GED programs, domestic violence programs, transportation/utilities assistance programs, etc.), changes in each study participant's awareness of, knowledge about, and likelihood of accessing resources will be assessed.
Change in Perceived Stress Baseline, 12 months Comparison of intervention and control participants of their change in social support scores between baseline and 12 months as measured by the summed scores of the 14-item Perceived Stress Scale (PSS-14). Summed scores range from 0 to 56 with higher scores indicating higher levels of stress. Changes will be measured as 12 months - Baseline, so negative change scores indicate decreased perceived stress.
Trial Locations
- Locations (2)
Centro Savila
🇺🇸Albuquerque, New Mexico, United States
One Hope Centro De Vida Health Center
🇺🇸Albuquerque, New Mexico, United States
Centro Savila🇺🇸Albuquerque, New Mexico, United States