- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926247
Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants (IWP)
Addressing the Social-Structural Determinants of Mental Health Through Adaptation of a Transdisciplinary Ecological Intervention Model for Mexican Immigrants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this research is to advance the science of community-level mental health interventions that aim to reduce social inequities and health disparities. The proposed study will adapt and integrate a successfully implemented multilevel, ecological intervention that addresses social-structural determinants of mental health into existing efforts at three community partner organizations that focus on mental health, education, legal, and civil rights issues for Mexican immigrants in New Mexico. Using a mixed methods longitudinal design, the processes and outcomes of the collaborative, community-based intervention efforts, including the impact of the quality of the community-based participatory research (CBPR) partnerships on individual, organizational, and community-level outcomes, will be illuminated.
Social and structural inequities contribute significantly to increasing health disparities globally, with the increasing numbers of migrants throughout the world bearing a disproportionate burden. The immigrant share of the U.S. population has risen steadily over the past four decades, comprising 13.5% of the total population in 2015, with Mexican-born immigrants accounting for 27% of all immigrants. The social, legal, and economic context of the migration process, including increasing uncertainty, discrimination, stigma, lack of access to resources, and fear of deportation and family separation based on immigration policies and public perception of immigrants as a threat all have a critical impact on adverse mental health outcomes among Mexican immigrants in the U.S. In addition, Mexican immigrants have low utilization rates for mental healthcare, in part because of barriers that include lack of health insurance, ineligibility for governmental health programs, discrimination, lack of interpretation services and culturally appropriate care, and an anti-immigrant political and economic climate. Although evidence points to the need to address socio-structural determinants, many mental health interventions offered to Mexican immigrants have focused on individual-level predictors of mental health. Also, Mexican immigrants' health outcomes are often viewed within the Latino health paradox, and therefore are frequently overlooked in mental health research and development of appropriate interventions, despite mounting evidence of mental health disparities and disproportionate exposure to trauma. Thus, multilevel, transdisciplinary intervention approaches that address social-structural determinants of mental health, are culturally appropriate, build upon Mexican immigrants' strengths, are cost-effective and scalable, and occur in non-stigmatized settings are needed.
In prior NIH-funded research, the PI and community partners developed and tested a 6-month community-based advocacy, learning, and social support intervention, which pairs paraprofessional university students with refugee adults to engage in mutual learning and social change efforts. The intervention was found to decrease participants' psychological distress, improve their quality of life, access to resources, social support, and English proficiency, and improve communities' responsiveness to refugees; and also proved to be highly acceptable, cost effective, and sustainable. The objective of this study is to: a) adapt the intervention for Mexican immigrants (Immigrant Wellbeing Project; IWP); b) integrate IWP into existing efforts at three community partner organizations; and c) elucidate new understandings of partnership and intervention processes that lead to sustainable multilevel changes and the reduction of mental health disparities and related social inequities.
Aim 1. Conduct an in-depth study of the mental health needs, stressors, current political/economic/social context, and local solutions as experienced by 24 Mexican recent and non-recent immigrants and their families residing in Bernalillo County New Mexico and contextualized by staff at three community partner organizations.
Aim 2. Building on the data from Aim 1, use a CBPR approach to adapt the intervention model (IWP) and integrate it within existing service delivery and social change efforts at three community partner organizations.
Aim 3. Using a mixed methods longitudinal design, investigate the feasibility and acceptability of the adapted community-based mental health intervention and test the quality of the CBPR partnership and impact of the intervention on mental health problems and protective factors among 90 Mexican immigrants and on organizational and government changes in policies and practices impacting immigrant mental health.
3.1 The IWP and collaborative adaptation/integration process will be feasible and acceptable and will serve as a model for implementing and studying multilevel, community-based intervention efforts.
3.2 IWP participants' psychological distress will decrease significantly over time.
3.3 IWP participants' protective factors (access to resources, English proficiency, environmental mastery, social support) will increase significantly over time.
3.4 Lower levels of psychological distress will be mediated by the protective factors.
3.5 Qualitative data will document changes in organizational and governmental policies and practices and the context of implementation at each site, explore other impacts, and inform interpretation of quantitative data.
3.6 Quality of CBPR partnership at each site will be related to policy/practice changes and health outcomes.
As one of the core research projects of the Transdisciplinary Research, Equity and Engagement Center for Advancing Behavioral Health (TREE), this study will benefit from and contribute to collaborative efforts to elucidate and address the impact of social-structural (e.g., racism, lack of access to resources) and historical (e.g., violence, trauma, colonization) determinants of mental health for immigrant and indigenous populations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mexican immigrant
- Residing in Bernalillo County, New Mexico
Exclusion Criteria:
- Severe cognitive functioning problems
- Imminent suicide risk
- Mental illness that is so severe as to impede participation in a group and that warrants immediate individual treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Immigrant Well-being Project Intervention
Intervention
|
The IWP intervention emphasizes a sustainable and replicable partnership model between community-based organizations and universities that involves Mexican immigrants and undergraduate advocates working together to: a) increase immigrants' abilities to navigate their communities; b) improve immigrants' access to community resources; c) enhance meaningful social roles by valuing immigrants' culture, experiences, and knowledge; d) reduce immigrants' social isolation; and e) increase communities' responsiveness to immigrants through changes in policy and practice.
The IWP is administered by university students enrolled in a service learning course, and has two elements: 1) Learning Circles, which involve cultural exchange and one-on-one learning opportunities, and; 2) Advocacy, which involves collaborative efforts to mobilize community resources related to health, housing, employment, education, and legal issues.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Hopkins Symptom Checklist-25 (HSC-25).
Minimum=1.00,
Maximum=4.00.
Lower scores indicate better outcome (lower levels of depression/anxiety symptoms).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
|
Linear Change From Baseline to 14-month Follow-up in PTSD Symptom Score Assessed by the PTSD Symptom Checklist (Civilian Version)
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
PTSD Symptom Checklist (Civilian Version, PCL-C).
Minimum=17.00,
Maximum=85.00.
Lower scores indicate better outcome (lower levels of PTSD symptoms).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
|
Linear Change From Baseline to 14-month Follow-up in Stress Assessed by the Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Abbreviated Hispanic Stress Inventory.
Minimum=0.00,
Maximum=3.00.
Lower scores indicate better outcome (lower levels of stress).
We adapted this measure for our study - based on community member input, we reduced response choices to 4 (from 5).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Multi-Sector Social Support Inventory.
Minimum=0.00,
Maximum=4.00.
Higher scores indicate better outcome (higher levels of social support).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
|
Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Satisfaction With Resources Scale
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Satisfaction with Resources Scale.
Minimum=0.00,
Maximum=6.00.
Higher scores indicate better outcome (higher satisfaction with resources).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
|
Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Difficulty Accessing Resources Scale
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Difficulty Accessing Resources Scale.
Minimum=1.00,
Maximum=4.00.
Lower scores indicate better outcome (lower levels of difficulty accessing resources).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
|
Linear Change From Baseline to 14-month Follow-up in Quality of Life Assessed by the World Health Organization Quality of Life Assessment
Time Frame: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
World Health Organization Quality of Life assessment (WHOQOL).
Minimum=3.00,
Maximum=15.00.
Higher scores indicate better outcome (higher quality of life).
|
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica R Goodkind, PhD, University of New Mexico
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22217
- U54MD004811 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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