- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03527654
SER Hispano Longitudinal Study
May 25, 2022 updated by: Duke University
SER Study: Salud, Estrés, y Resilencia (Health, Stress, and Resilience) Among Young Adult Hispanic Immigrants in the U.S.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
390
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke School of Nursing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 44 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
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.
Description
Inclusion Criteria:
- identifying as Hispanic or Latino,
- between 18 and 44 years of age,
- immigrating to the U.S., and
- residing in the the U.S. for at least 1 year.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hispanic Immigrants
|
Surveys, blood and urine collected prospectively over 24 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
|
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.
|
Baseline, 6 months, 12 months, 18 months, 24 months
|
Change in biological stress markers
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
|
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.
|
Baseline, 6 months, 12 months, 18 months, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rosa Gonzalez-Guarda, PhD, Duke University School of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 2, 2018
Primary Completion (ACTUAL)
January 2, 2022
Study Completion (ACTUAL)
January 2, 2022
Study Registration Dates
First Submitted
April 27, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (ACTUAL)
May 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PRO00087792
- 1R01MD012249-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Taichung Veterans General HospitalUnknown
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
Clinical Trials on Observational
-
American Gastroenterological AssociationUniversity of Pennsylvania; University of California, San Diego; University of... and other collaboratorsRecruitingClostridium Difficile Infection | Gut Microbiome | Fecal Microbiota TransplantationUnited States, Canada
-
University of MinnesotaAgency for Healthcare Research and Quality (AHRQ)RecruitingTraumatic Brain Injury | Venous ThromboembolismUnited States
-
Massachusetts General HospitalRecruiting
-
Taysha Gene Therapies, Inc.Withdrawn
-
University Hospital, AntwerpUniversiteit AntwerpenUnknownType 1 Diabetes | Diastolic Dysfunction | Coronary Artery CalcificationsBelgium
-
St. Louis UniversityActive, not recruitingVertebral Artery StenosisUnited States
-
University Hospital, Basel, SwitzerlandCompletedPostoperative Complications | Intraoperative Complications | Patient Safety | Risk ManagementNew Zealand, Switzerland, United States, Netherlands, Spain, Austria, Turkey, United Kingdom, Australia, Greece, Ireland, Italy
-
University of Castilla-La ManchaRecruitingKnee OsteoarthritisSpain
-
AstraZenecaRecruiting
-
AstraZenecaRecruitingNon-Small Cell Lung CancerUnited States