ClinicalTrials.gg
CompletedNCT03527654Updated May 26, 2022

SER Hispano Longitudinal Study

An observational study in Stress, Acculturation and Health, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by Duke University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
390
Ages
18 Years to 44 Years
Sex
All
01

Study summary

Hispanic immigrants to the U.S. are more likely to experience negative health outcomes the longer they live in the U.S. For example, over time Hispanic immigrants engage in riskier behaviors such as substance abuse, violence, and risky sex, and experience more depressive symptoms. The stress associated with the acculturation process, acculturation stress, and resilience at the individual, family, community, and societal levels appear to play important roles in influencing risks. However, little is known about the causal mechanisms linking acculturation stress, resilience, and health outcomes among Hispanic immigrants. Further, little is known about what precise types of stressors (e.g., occupational stress vs. discrimination) and resilience factors (e.g., individual coping vs. family support) have the most important influence on health trajectories of Hispanic immigrants. The proposed longitudinal study (N = 385) will investigate the effects of acculturation stress and resilience on co-occurring substance abuse, intimate partner violence, HIV risk, and depression (i.e., syndemic conditions) and biological stress among young adult Hispanic immigrants in the U.S. More specifically, the proposed project aims to: 1) test theoretical links between the cumulative impact of acculturation stress and resilience on syndemic conditions and biological stress among recent young adult Hispanic immigrants over a two-year period, and 2) identify the specific types of acculturation stressors and resilience factors at the individual, family, community, and societal levels that are most important in predicting syndemic conditions and biological stress among this population over time. Young adult low-income Hispanic immigrant men and women within the first 10 years of immigration will be followed for two years. Biopsychosocial data will be collected from participants at baseline, and then 6 months (FU1), 12 months (FU2), 18 months (FU3), and 24 months later (FU4). Culturally specific measures of acculturation stress and resilience will be used to assess for individual, family, community, and societal risk and protective factors for syndemic conditions. Blood and urine samples will be obtained from participants to measure systemic inflammation (IL 6, IL8, and IL 18) and oxidative stress (F2 isoprostanes), previously validated biomarkers for psychological stress. Various descriptive, univariate and multivariate statistics, including latent growth curve modeling, will be used to address aims 1-2. The findings from this study have the potential to identify risk and protective factors for the decay in heath among Hispanic immigrants. A precise and culturally informed understanding of these phenomena is foundational for designing interventions that can ultimately promote the health and wellbeing of Hispanic immigrants, the largest immigrant group in the U.S. This study also has the potential to lay the theoretical foundation for biopsychosocial health disparities research in other populations.

02

Conditions studied

  • Stress
  • Acculturation
  • Health
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Male and female Hispanic immigrants participants between the ages of 18 and 44 living in Durham, Wake, and Orange counties.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. identifying as Hispanic or Latino,
  2. between 18 and 44 years of age,
  3. immigrating to the U.S., and
  4. residing in the the U.S. for at least 1 year.

Exclusion criteria

Exclusion criteria will include:

1. acute illness (e.g., cold, flu).

Participants do not need to be able to read, as the questions and responses will be read to the participants.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
390 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Hispanic Immigrants

    Other: Observational

Interventions

  • OtherObservational

    Surveys, blood and urine collected prospectively over 24 months.

06

What researchers measure

Primary outcomes

  1. Change in syndemic conditions, as measured by the AUDIT, DAST, Revised Conflict Tactics Scale, the Partner table and STI History, the PHQ-9, and the GAD-7.

    The AUDIT (Babor et. al., 2001) measure has 10 items that assess frequency of drinking and alcohol use disorder symptoms. The DAST (Skinner, 1982) measure, has 10 items that measure drug abuse symptoms. The Revised Conflict Tactics Scale (Strauss \& Douglas, 2004) has 24 items that assess conflict between partners and intimate partner violence. The Partner Table \& STI History (Gonzalez-Guarda et. al., 2011) has 25 items that assess current sexual practices and risk for sexually transmitted infections including HIV. The PHQ-9 (Kroenke et al., 2002) has 9 items that assess severity depression. The GAD-7 (Spitzer et. al., 2006) contains 7 items that assess anxiety for the individual.

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

  2. Change in biological stress markers

    The Inflammatory Cytokines lab test, measures systemic inflammation in body fluid samples (blood and Urine) specifically cytokines IL6, IL8 and IL18. The F2 Isoprostanes measures oxidative stress markers in body fluid samples (blood and Urine) within cells.

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

07

Study locations

1 site
  • Duke School of Nursing
    Durham, North Carolina 27710, United States
08

References and documents

Publications

  • Felsman IC, Emerson MM, McCabe BE, Nagy G, Gonzalez-Guarda RM. A Hispanic/Latino Community Health Worker Intervention Addressing Acculturative Stress and Resilience: Feasibility, Acceptability, and Preliminary Effectiveness. J Immigr Minor Health. 2026 Feb 14. doi: 10.1007/s10903-026-01859-2. Online ahead of print. PubMed 41689619 ↗
  • Gonzalez-Guarda RM, McCabe BE, Nagy GA, Stafford AM, Matos L, Lu M, Felsman I, Rocha-Goldberg P, Cervantes RC. Acculturative Stress, Resilience, and a Syndemic Factor Among Latinx Immigrants. Nurs Res. 2023 Jul-Aug 01;72(4):249-258. doi: 10.1097/NNR.0000000000000655. Epub 2023 Mar 11. PubMed 37350696 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Jan 2022, 44 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2018
First posted
May 17, 2018
StartActual
May 2, 2018
Primary completionActual
Jan 2, 2022
CompletionActual
Jan 2, 2022
Last update
May 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03527654
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
May 17, 2018
Start date
May 2, 2018
Primary completion
Jan 2, 2022
Completion
Jan 2, 2022
Last update
May 26, 2022

Study contacts

Rosa Gonzalez-Guarda, PhD
principal investigator · Duke University School of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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