NCT03926247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3.9 years

First QC Date

April 12, 2019

Results QC Date

May 10, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

pilot studymental healthimmigrantwithin-group longitudinal design

Outcome Measures

Primary Outcomes (3)

  • 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).

    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)

    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

    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 Outcomes (4)

  • Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory

    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

    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

    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

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

Study Arms (1)

Immigrant Well-being Project Intervention

OTHER

Intervention

Behavioral: Immigrant Well-Being Project

Interventions

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.

Immigrant Well-being Project Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mexican immigrant
  • Residing in Bernalillo County, New Mexico

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Dr. Jessica Goodkind
Organization
University of New Mexico

Study Officials

  • Jessica R Goodkind, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a pilot study of an intervention with a within-group longitudinal design. All participants will participate in the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Sociology

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 24, 2019

Study Start

March 13, 2018

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

October 15, 2024

Results First Posted

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations