Trial Outcomes & Findings for Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants (NCT NCT03926247)
NCT ID: NCT03926247
Last Updated: 2024-10-15
Results Overview
Hopkins Symptom Checklist-25 (HSC-25). Minimum=1.00, Maximum=4.00. Lower scores indicate better outcome (lower levels of depression/anxiety symptoms).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Immigrant Well-being Project Intervention
Intervention
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.
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|---|---|
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Overall Study
STARTED
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56
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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25
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants
Baseline characteristics by cohort
| Measure |
Immigrant Well-being Project Intervention
n=54 Participants
Intervention
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.
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|---|---|
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Age, Continuous
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39.06 years
STANDARD_DEVIATION 9.89 • n=5 Participants
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Sex: Female, Male
Female
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46 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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54 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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54 Participants
n=5 Participants
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Region of Enrollment
United States
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54 participants
n=5 Participants
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Perceived English Proficiency
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1.12 units on a scale
STANDARD_DEVIATION 0.72 • n=5 Participants
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Satisfaction with Resources
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3.18 units on a scale
STANDARD_DEVIATION 1.00 • n=5 Participants
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Difficulty Accessing Resources
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2.51 units on a scale
STANDARD_DEVIATION 1.29 • n=5 Participants
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Multisectoral Social Support Inventory
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2.14 units on a scale
STANDARD_DEVIATION 0.76 • n=5 Participants
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Collective Efficacy
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2.85 units on a scale
STANDARD_DEVIATION 0.88 • n=5 Participants
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Social Cohesion
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3.12 units on a scale
STANDARD_DEVIATION 0.85 • n=5 Participants
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WHO Psychological Wellbeing
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10.51 units on a scale
STANDARD_DEVIATION 2.44 • n=5 Participants
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WHO Physical Wellbeing
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8.60 units on a scale
STANDARD_DEVIATION 2.75 • n=5 Participants
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WHO Environmental Wellbeing
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10.21 units on a scale
STANDARD_DEVIATION 2.87 • n=5 Participants
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Hispanic Stress Inventory
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1.31 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
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Hopkins Symptom Checklist
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1.61 units on a scale
STANDARD_DEVIATION 0.48 • n=5 Participants
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HSC Depression Subscale
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1.64 units on a scale
STANDARD_DEVIATION 0.49 • n=5 Participants
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HSC Anxiety Subscale
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1.57 units on a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
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PTSD Symptom Checklist
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28.44 units on a scale
STANDARD_DEVIATION 12.35 • n=5 Participants
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Trauma Exposure
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6.42 units on a scale
STANDARD_DEVIATION 5.26 • n=5 Participants
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Resilience (CDRISC)
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2.70 units on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
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Major Discrimination Scale
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0.20 units on a scale
STANDARD_DEVIATION 0.18 • n=5 Participants
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Everyday Discrimination Scale
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0.78 units on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
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Work Discrimination Scale
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2.66 units on a scale
STANDARD_DEVIATION 1.65 • n=5 Participants
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Heightened Vigilance Scale
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2.96 units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
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PRIMARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
Hopkins Symptom Checklist-25 (HSC-25). Minimum=1.00, Maximum=4.00. Lower scores indicate better outcome (lower levels of depression/anxiety symptoms).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=39 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25
Timepoint 1 (Baseline)
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1.60 score on a scale
Standard Error 0.08
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Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25
Timepoint 2 (Mid-Intervention)
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1.56 score on a scale
Standard Error 0.07
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Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25
Timepoint 3 (Post-Intervention)
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1.47 score on a scale
Standard Error 0.08
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Linear Change From Baseline to 14-month Follow-up in Depression/Anxiety Symptom Score Assessed by the Hopkins Symptom Checklist-25
Timepoint 4 (8-month follow-up)
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1.49 score on a scale
Standard Error 0.08
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PRIMARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
PTSD Symptom Checklist (Civilian Version, PCL-C). Minimum=17.00, Maximum=85.00. Lower scores indicate better outcome (lower levels of PTSD symptoms).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=38 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in PTSD Symptom Score Assessed by the PTSD Symptom Checklist (Civilian Version)
Timepoint 1 (Pre-intervention)
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28.72 score on a scale
Standard Error 1.99
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Linear Change From Baseline to 14-month Follow-up in PTSD Symptom Score Assessed by the PTSD Symptom Checklist (Civilian Version)
Timepoint 2 (Mid-intervention)
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29.34 score on a scale
Standard Error 1.99
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Linear Change From Baseline to 14-month Follow-up in PTSD Symptom Score Assessed by the PTSD Symptom Checklist (Civilian Version)
Timepoint 3 (Post-intervention)
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25.32 score on a scale
Standard Error 2.05
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Linear Change From Baseline to 14-month Follow-up in PTSD Symptom Score Assessed by the PTSD Symptom Checklist (Civilian Version)
Timepoint 4 (8-month follow-up)
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27.05 score on a scale
Standard Error 2.00
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PRIMARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
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).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=32 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in Stress Assessed by the Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress
Timepoint 1 (Baseline)
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1.32 score on a scale
Standard Error 0.11
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Linear Change From Baseline to 14-month Follow-up in Stress Assessed by the Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress
Timepoint 2 (Mid-intervention)
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1.38 score on a scale
Standard Error 0.11
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Linear Change From Baseline to 14-month Follow-up in Stress Assessed by the Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress
Timepoint 3 (Post-intervention)
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1.16 score on a scale
Standard Error 0.11
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Linear Change From Baseline to 14-month Follow-up in Stress Assessed by the Abbreviated Hispanic Stress Inventory Scale - Culturally-Specific Distress
Timepoint 4 (8-month follow-up)
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1.18 score on a scale
Standard Error 0.12
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SECONDARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
Multi-Sector Social Support Inventory. Minimum=0.00, Maximum=4.00. Higher scores indicate better outcome (higher levels of social support).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=39 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory
Timepoint 1 (Baseline)
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2.32 score on a scale
Standard Error 0.11
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Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory
Timepoint 2 (Mid-intervention)
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2.32 score on a scale
Standard Error 0.11
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Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory
Timepoint 3 (Post-intervention)
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2.29 score on a scale
Standard Error 0.12
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Linear Change From Baseline to 14-month Follow-up in Social Support Assessed by the Multi-Sector Social Support Inventory
Timepoint 4 (8-month follow-up)
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2.21 score on a scale
Standard Error 0.12
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SECONDARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
Satisfaction with Resources Scale. Minimum=0.00, Maximum=6.00. Higher scores indicate better outcome (higher satisfaction with resources).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=28 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Satisfaction With Resources Scale
Timepoint 1 (Baseline)
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3.15 score on a scale
Standard Error 0.18
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Satisfaction With Resources Scale
Timepoint 2 (Mid-intervention)
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3.46 score on a scale
Standard Error 0.17
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Satisfaction With Resources Scale
Timepoint 3 (Post-intervention)
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3.55 score on a scale
Standard Error 0.18
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Satisfaction With Resources Scale
Timepoint 4 (8-month follow-up)
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3.43 score on a scale
Standard Error 0.17
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SECONDARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
Difficulty Accessing Resources Scale. Minimum=1.00, Maximum=4.00. Lower scores indicate better outcome (lower levels of difficulty accessing resources).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=34 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Difficulty Accessing Resources Scale
Timepoint 1 (Baseline)
|
2.55 score on a scale
Standard Error 0.15
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Difficulty Accessing Resources Scale
Timepoint 2 (Mid-intervention)
|
2.34 score on a scale
Standard Error 0.15
|
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Difficulty Accessing Resources Scale
Timepoint 3 (Post-intervention)
|
2.46 score on a scale
Standard Error 0.17
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Linear Change From Baseline to 14-month Follow-up in Access to Resources Assessed by the Difficulty Accessing Resources Scale
Timepoint 4 (8-month follow-up)
|
2.16 score on a scale
Standard Error 0.15
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SECONDARY outcome
Timeframe: Timepoints used in calculation: baseline, 3 months (mid), 6 months (post), 14 months (follow-up)Population: 56 participants enrolled in the study and participated in the intervention; we included participants in a particular outcome analysis if they had data for the outcome at a minimum of two timepoints (one of which had to be either the first or second timepoint).
World Health Organization Quality of Life assessment (WHOQOL). Minimum=3.00, Maximum=15.00. Higher scores indicate better outcome (higher quality of life).
Outcome measures
| Measure |
Immigrant Well-being Project Intervention
n=39 Participants
Intervention
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.
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|---|---|
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Linear Change From Baseline to 14-month Follow-up in Quality of Life Assessed by the World Health Organization Quality of Life Assessment
Timepoint 1 (Baseline)
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10.40 units on a scale
Standard Error 0.38
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Linear Change From Baseline to 14-month Follow-up in Quality of Life Assessed by the World Health Organization Quality of Life Assessment
Timepoint 2 (Mid-intervention)
|
10.55 units on a scale
Standard Error 0.38
|
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Linear Change From Baseline to 14-month Follow-up in Quality of Life Assessed by the World Health Organization Quality of Life Assessment
Timepoint 3 (Post-intervention)
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10.68 units on a scale
Standard Error 0.40
|
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Linear Change From Baseline to 14-month Follow-up in Quality of Life Assessed by the World Health Organization Quality of Life Assessment
Timepoint 4 (8-month follow-up)
|
9.73 units on a scale
Standard Error 0.38
|
Adverse Events
Immigrant Well-being Project Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place