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

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ClinicalTrials.gov Identifier: NCT03926247
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jessica Goodkind, University of New Mexico

Brief 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 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.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: Immigrant Well-Being Project Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Addressing the Social-Structural Determinants of Mental Health Through Adaptation of a Transdisciplinary Ecological Intervention Model for Mexican Immigrants
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Immigrant Well-being Project Intervention
Intervention
Behavioral: Immigrant Well-Being Project
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.




Primary Outcome Measures :
  1. Hopkins Symptom Checklist-25: Depression/Anxiety symptoms [ Time Frame: 14 months ]
    Overall Distress Scale obtained as mean of all 25 items, range is 1-4 Depression symptom subscale is mean of 15 items (11-25), range is 1-4 Anxiety symptom subscale is mean of 10 items (1-10), range is 1-4 Higher scores indicate more depression/anxiety symptoms (worse outcome)

  2. PTSD Symptom Checklist (Civilian Version) [ Time Frame: 14 months ]
    Overall Symptom Severity is total of all 17 items; range is 17-85; higher score indicates more PTSD symptoms (worse outcome)

  3. Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress [ Time Frame: 14 months ]
    Overall Stress is mean of 25 items; range is 0-3; higher score indicates more distress/stress (worse outcome)


Secondary Outcome Measures :
  1. Multi-Sector Social Support Inventory [ Time Frame: 14 months ]
    Three subscales, each with 7 parallel items: Family Social Support, Ethnic Group Social Support, Non-Ethnic Community Social Support; each subscale is calculated as the mean of the relevant 7 items; range 0-4; higher scores indicate more social support (better outcome)

  2. Satisfaction with Resources Scale [ Time Frame: 14 months ]
    Mean of 12 items assessing satisfaction with resources in different life areas; range 0-6; higher score indicates greater satisfaction (better outcome)

  3. Difficulty Accessing Resources Scale [ Time Frame: 14 months ]
    Mean of 12 items assessing difficulty accessing resources in different life areas; range 1-4; higher score indicates more difficulty (worse outcome)

  4. World Health Organization Quality of Life assessment [ Time Frame: 14 months ]
    Total of 26 items; range 26-130; higher score indicates better quality of life (better outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926247


Contacts
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Contact: Alicia V Rodriguez, MPA 505-994-5081 avrodriguez@salud.unm.edu
Contact: Jessica R Goodkind, PhD 505-277-2002 jgoodkin@unm.edu

Locations
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United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Jessica Goodkind, Ph.D.    505-277-2501    jgoodkin@unm.edu   
Sponsors and Collaborators
University of New Mexico
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Jessica R Goodkind, PhD University of New Mexico
  Study Documents (Full-Text)

Documents provided by Jessica Goodkind, University of New Mexico:
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Responsible Party: Jessica Goodkind, Associate Professor of Sociology, University of New Mexico
ClinicalTrials.gov Identifier: NCT03926247    
Other Study ID Numbers: 22217
U54MD004811 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Goodkind, University of New Mexico:
pilot study
mental health
immigrant
within-group longitudinal design