AzTrials
AzTrials

Mental HealthIWPNCT03926247

Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants

A study testing Immigrant Well-Being Project in people with Mental Health, 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
Search all trials

Trial summary

The goal of this study is to test a transdisciplinary ecological approach to reducing mental health disparities among Mexican immigrants by adapting and integrating a multilevel community-based advocacy, learning, and social support intervention (Immigrant Well-being Project, IWP) into existing efforts at three… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
Immigrant Well-Being Project
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
13 Mar 2018to 15 Feb 2022
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Mexican immigrant
  • Residing in Bernalillo County, New Mexico

Who cannot join

  • 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

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: Addressing the Social-Structural Determinants of Mental Health Through Adaptation of a Transdisciplinary Ecological Intervention Model for Mexican Immigrants

The goal of this study is to test a transdisciplinary ecological approach to reducing mental health disparities among Mexican immigrants by adapting and integrating a multilevel community-based advocacy, learning, and social support intervention (Immigrant Well-being Project, IWP) into existing efforts at three community partner organizations that focus on mental health, education, legal, and civil rights issues for Mexican immigrants. This research is innovative and significant because it employs cutting edge strategies to address social-structural determinants of mental health and examines the community-engaged process of adapting and testing the impact of a multilevel intervention originally designed for refugees. 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. Studies of the intervention model with refugees demonstrated feasibility, appropriateness, acceptability, and evidence that the intervention decreased participants' psychological distress and increased protective factors, and impacted changes in system-wide policies and practices. After completing in-depth ethnographic interviews with 24 Mexican immigrant adults to elucidate their mental health needs, stressors, current political/economic/social context, and local solutions, and a process of community engagement and intervention adaptation, a mixed methods strategy with data collected from 90 participants at four time points over a period of 14 months will be used to test the impact of the 6-month intervention on reducing psychological distress, increasing protective factors (access to resources, English proficiency, environmental mastery, and social support), and achieving system-level changes in organizational, local, and state policies and practices that impact Mexican immigrants' well-being. Mechanisms of intervention effectiveness will be explored by testing mediating relationships between protective factors and psychological distress. Qualitative data will explore feasibility and acceptability of the intervention, participants' experiences in the intervention, and unexpected impacts; document multilevel changes and the context of implementation at each site; and inform interpretation of quantitative data. Quantitative and qualitative data on the quality of the CBPR partnerships and their relationship to multilevel outcomes will also be examined.

Read the 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.

Conditions
Mental Health
Being tested
Immigrant Well-Being Project
Keywords
pilot study, mental health, immigrant, within-group longitudinal design
Medical subject headings
Psychological Well-Being

What participants receive

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

  • Immigrant Well-Being ProjectBehavioural

    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.

Study groups in NCT03926247
Study groupRoleWhat they receive
Immigrant Well-being Project InterventionOtherIntervention
Receives: Behavioral: Immigrant Well-Being Project

What is being measured

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

  1. Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25

    Hopkins Symptom Checklist-25 (HSC-25). Minimum=1.00, Maximum=4.00. Lower scores indicate better outcome (lower levels of depression/anxiety symptoms).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

  2. Linear Change From Baseline to 14-month Follow-up in PTSD Symptom Score Assessed by the PTSD Symptom Checklist (Civilian Version)

    PTSD Symptom Checklist (Civilian Version, PCL-C). Minimum=17.00, Maximum=85.00. Lower scores indicate better outcome (lower levels of PTSD symptoms).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

  3. Linear Change From Baseline to 14-month Follow-up in Stress Assessed by the Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress

    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).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

Secondary outcomes (4)
  1. Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory

    Multi-Sector Social Support Inventory. Minimum=0.00, Maximum=4.00. Higher scores indicate better outcome (higher levels of social support).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

  2. Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Satisfaction With Resources Scale

    Satisfaction with Resources Scale. Minimum=0.00, Maximum=6.00. Higher scores indicate better outcome (higher satisfaction with resources).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

  3. Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Difficulty Accessing Resources Scale

    Difficulty Accessing Resources Scale. Minimum=1.00, Maximum=4.00. Lower scores indicate better outcome (lower levels of difficulty accessing resources).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

  4. Linear Change From Baseline to 14-month Follow-up in Quality of Life Assessed by the World Health Organization Quality of Life Assessment

    World Health Organization Quality of Life assessment (WHOQOL). Minimum=3.00, Maximum=15.00. Higher scores indicate better outcome (higher quality of life).

    Measured: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)

Timeline

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

  1. First posted24 Apr 2019
  2. Study start13 Mar 2018
  3. Primary completion15 Feb 2022
  4. Study completion15 Feb 2022

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This is a pilot study of an intervention with a within-group longitudinal design. All participants will participate in the intervention.
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926247
Sponsor's protocol ID
22217
Other IDs
U54MD004811
Acronym
IWP
Status last verified
Oct 2024
First submitted
12 Apr 2019
Last updated
15 Oct 2024
Data monitoring committee
Yes
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 Immigrant Well-Being Project in people with Mental Health, 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 2 inclusion and 3 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 15 Oct 2024. 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 15 Oct 2024). 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?

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)). The study lists 3 primary outcomes in all. 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 15 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in