StressNCT03527654
SER Hispano Longitudinal Study
An observational study of Stress and Acculturation, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Stress, Acculturation, Health
- What is being tested?
- Observational
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2018to 2 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Adult
Study population: Male and female Hispanic immigrants participants between the ages of 18 and 44 living in Durham, Wake, and Orange counties.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke School of Nursing
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Stress, Acculturation, Health
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Surveys, blood and urine collected prospectively over 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Hispanic Immigrants | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start2 May 2018
- Primary completion2 Jan 2022
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Rosa Gonzalez-Guarda, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527654
- Sponsor's protocol ID
- PRO00087792
- Other IDs
- 1R01MD012249-01
- Status last verified
- May 2022
- First submitted
- 27 Apr 2018
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41689619Gonzalez-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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SER Study: Salud, Estrés, y Resilencia (Health, Stress, and Resilience) Among Young Adult Hispanic Immigrants in the U.S.
- ClinicalTrials.gov ID
- NCT03527654
- Acronym / sponsor ID
- PRO00087792
- Conditions
- Stress, Acculturation, Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hispanic Immigrants | – | Other: Observational |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Age groups
- Adult
- Study population
- Male and female Hispanic immigrants participants between the ages of 18 and 44 living in Durham, Wake, and Orange counties.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalSurveys, blood and urine collected prospectively over 24 months. | Other | Hispanic Immigrants |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 41689619Felsman 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.
- Derived from this study: PubMed 37350696Gonzalez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Gonzalez-Guarda, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Acculturation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527654, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.