Acculturative StressREACH EquityNCT04785339
Acculturative Stress Intervention (REACH Equity CDA)
A study testing intervention in adult Latinx immigrants in people with Acculturative Stress, run by Duke University.
Trial summary
The overarching aim of the study is to garner empirical support for intervention components that can reduce acculturative stress in Latinx immigrants. Informed by our review of the literature and our prior research, we hypothesize that we can target the following mechanisms in a modularized group intervention format… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acculturative Stress
- What is being tested?
- intervention in adult Latinx immigrants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 30 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old,
- Latinx/Hispanic Self identifying
- Immigrant (born outside of the US)
Who cannot join
- Active suicidal ideation (i.e., imminent SI in the last 12 months AND ≥1 suicide attempts in the last 10 years)
- Unmanaged severe mental illness (i.e., psychotic disorder, manic symptoms, eating disorder, substance use disorder)
About this study
Official title: Latinx Acculturative Stress Intervention Development and Implementation (REACH Equity CDA)
The overarching aim of the study is to garner empirical support for intervention components that can reduce acculturative stress in Latinx immigrants. Informed by our review of the literature and our prior research, we hypothesize that we can target the following mechanisms in a modularized group intervention format, as detailed below. These are preliminary areas targeted by the intervention, but may be updated based on feedback from the Community Advisory Board, Community Consultation Studio, and Duke Health key informants.
Read the detailed description
As health disparities widen for Latinx immigrants, there is an urgent unmet public health need to develop an evidence-based interventions reducing stress experienced by this population that can be easily scalable across diverse clinical settings and geographically distinct immigrant communities. Thus, the purpose of this study is to develop and pilot test a novel group acculturative stress intervention for Latinx immigrants.
Study activities Aim 1: Co-develop an acculturation stress intervention for adult Latinx immigrants to decrease stress, increase resilience, and prevent declines in mental and physical health.
Aim 2: Examine the preliminary clinical impact, feasibility, and acceptability of a group acculturative stress in Latinx immigrants and collect information to inform subsequent implementation.
Aim 2a: Conduct pilot testing of the group intervention in Latinx immigrant participants (N=24-30)to evaluate its preliminary clinical impact from baseline to post-assessment on stress, resilience, and health outcomes (e.g., depression, anxiety, self-rated health).
Aim 2b: Characterize the inner and outer context, facilitators, barriers, intent to adopt, and resources across the Duke University Health System through multiple stakeholder interviews with providers and administrators (n=8-10).
- Conditions
- Acculturative Stress
- Being tested
- intervention in adult Latinx immigrants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention in adult Latinx immigrantsBehavioural
Participants will complete self-report outcome measures at pre (baseline) and post, and they will receive the intervention in-between these assessments. Thus, the time frame for data collection is 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| one-arm, pre-post design | Experimental | This study will test an intervention in adult Latinx immigrants. There will be no control condition or other comparators. One condition will only provide data at pre (baseline) and post. The only comparison will be across time, but not across conditions as this will be the only condition and all participants will receive the same intervention. Receives: Behavioral: intervention in adult Latinx immigrants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acculturative Stress as measured by the Hispanic Stress Inventory-2
Hispanic Stress Inventory-2 is 24 item questionnaire asking about stress on a scale of 1 to 5, where 1 is not stressed and 5 is very stressed".
Measured: 10 weeks
Perceived Stress as measured by the Perceived Stress Scale
The Perceived Stress scale is a 23-item questionnaire asking about stress on a scale of 1 to 5, where 1 is not stressed and 5 is extremely stressed.
Measured: 10 weeks
Dispositional resilience as measured by the Resiliency Scale
Resilience scale is a 25-item questionnaire asking resilience on a scale of 1 to 7, where 1 is disagree and 7 is strongly agree.
Measured: 10 weeks
Coping strategies as measured by the Brief COPE Scale
Brief COPE Scale is a 24-item questionnaire asking coping on a scale of 1 to 4, where is not at all and 4 is a lot.
Measured: 10 weeks
Ethnic Identity as measured by the Multigroup Ethnic Identity Measure
MEI is a 12-item questionnaire asking about Hispanic identity on a scale of 1 to 7, where 1 is strongly disagree and 7 is strongly agree.
Measured: 10 weeks
Familism as measured by Familism Scale.
Familism Scale is a 15 -item questionnaire asking about family welfare concern on a scale of 1 to 6, where 1 is strongly disagree and 6 is don't know.
Measured: 10 weeks
Social Support as measured by Social Support Questionnaire
Social Support Questionnaire is 16-item questionnaire asking about social support on a scale of 1 to 5, where 1 is Never and 5 is always.
Measured: 10 weeks
Secondary outcomes (7)
Anxiety symptoms as measured by GAD-7
Generalized Anxiety Disorder survey is a 7-item questionnaire asking problems anxiety on a scale 1 to 4, where 1 is not at all and 4 is Nearly every day.
Measured: 10 weeks
Depression symptoms as measured by PHQ-9
PHQ-9 is a self-reported patient health questionnaire survey is a 9 - item on a scale of 1 to 4, where 1 is Not at all and 4 is Nearly every day.
Measured: 10 weeks
Sleep Disturbance as measured by Sleep Disturbance
Sleep disturbance is a self-reported 4 questionnaire survey on a scale of 1 to 5, where 1 is very poor and 5 is very good.
Measured: 10 weeks
Drug Use as measured by Drug Abuse screening Test (DAST)
Drug use is asking the use of prescribed, over the counter in excess of direction and any nonmedical use of drugs on a scale of yes and no.
Measured: 10 weeks
Self-reported Physical Health as measured by Physical activity.
physical activity is a self-reported 2 questionnaire on a scale of 0 to 7.
Measured: 10 weeks
Self-reported Physical Health as measured by Short Form Health Survey
Short Form Health Survey is a 19-item self reported questionnaire on a scale of 1 to 5, where 1 is poor and 5 is Excellent.
Measured: 10 weeks.
Self-reported Physical Health as measured by Self-Rated Health
Self- Rated Health is a 7-item questionnaire on a scale of 1 to 5, where 1 is Excellent and 5 is poor.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start15 Jun 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: PI is leaving institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acculturative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * Aim 1: Co-develop an acculturation stress intervention for adult Latinx immigrants to decrease stress, increase resilience, and prevent declines in mental and physical health. * Aim 2: Examine the preliminary clinical impact, feasibility, and acceptability of a group acculturative stress in Latinx immigrants and collect information to inform subsequent implementation. Aim 2a: Conduct pilot testing of the group intervention in Latinx immigrant participants (N=24-30) to evaluate its preliminary clinical impact from baseline to post-assessment on stress, resilience, and health outcomes (e.g., depression, anxiety, self-rated health). o Aim 2b: Characterize the inner and outer context, facilitators, barriers, intent to adopt, and resources across the Duke University Health System through multiple stakeholder interviews with providers and administrators (n=8-10).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriela Nagy, Ph.D., Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785339
- Sponsor's protocol ID
- Pro00105969
- Acronym
- REACH Equity
- Status last verified
- Nov 2021
- First submitted
- 3 Mar 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinx Acculturative Stress Intervention Development and Implementation (REACH Equity CDA)
- ClinicalTrials.gov ID
- NCT04785339
- Acronym / sponsor ID
- REACH Equity / Pro00105969
- Conditions
- Acculturative Stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is leaving institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Mar 2021 (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.
The overarching aim of the study is to garner empirical support for intervention components that can reduce acculturative stress in Latinx immigrants. Informed by our review of the literature and our prior research, we hypothesize that we can target the following mechanisms in a modularized group intervention format, as detailed below. These are preliminary areas targeted by the intervention, but may be updated based on feedback from the Community Advisory Board, Community Consultation Studio, and Duke Health key informants.
Detailed description
As health disparities widen for Latinx immigrants, there is an urgent unmet public health need to develop an evidence-based interventions reducing stress experienced by this population that can be easily scalable across diverse clinical settings and geographically distinct immigrant communities. Thus, the purpose of this study is to develop and pilot test a novel group acculturative stress intervention for Latinx immigrants.
Study activities Aim 1: Co-develop an acculturation stress intervention for adult Latinx immigrants to decrease stress, increase resilience, and prevent declines in mental and physical health.
Aim 2: Examine the preliminary clinical impact, feasibility, and acceptability of a group acculturative stress in Latinx immigrants and collect information to inform subsequent implementation.
Aim 2a: Conduct pilot testing of the group intervention in Latinx immigrant participants (N=24-30)to evaluate its preliminary clinical impact from baseline to post-assessment on stress, resilience, and health outcomes (e.g., depression, anxiety, self-rated health).
Aim 2b: Characterize the inner and outer context, facilitators, barriers, intent to adopt, and resources across the Duke University Health System through multiple stakeholder interviews with providers and administrators (n=8-10).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Aim 1: Co-develop an acculturation stress intervention for adult Latinx immigrants to decrease stress, increase resilience, and prevent declines in mental and physical health. * Aim 2: Examine the preliminary clinical impact, feasibility, and acceptability of a group acculturative stress in Latinx immigrants and collect information to inform subsequent implementation. Aim 2a: Conduct pilot testing of the group intervention in Latinx immigrant participants (N=24-30) to evaluate its preliminary clinical impact from baseline to post-assessment on stress, resilience, and health outcomes (e.g., depression, anxiety, self-rated health). o Aim 2b: Characterize the inner and outer context, facilitators, barriers, intent to adopt, and resources across the Duke University Health System through multiple stakeholder interviews with providers and administrators (n=8-10).
| Arm | Type | Receives |
|---|---|---|
| one-arm, pre-post design | Experimental | Behavioral: intervention in adult Latinx immigrantsThis study will test an intervention in adult Latinx immigrants. There will be no control condition or other comparators. One condition will only provide data at pre (baseline) and post. The only comparison will be across time, but not across conditions as this will be the only condition and all participants will receive the same intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old,
- Latinx/Hispanic Self identifying
- Immigrant (born outside of the US)
Key exclusion criteria (2 listed)
- Active suicidal ideation (i.e., imminent SI in the last 12 months AND ≥1 suicide attempts in the last 10 years)
- Unmanaged severe mental illness (i.e., psychotic disorder, manic symptoms, eating disorder, substance use disorder)
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 |
|---|---|---|
| intervention in adult Latinx immigrantsParticipants will complete self-report outcome measures at pre (baseline) and post, and they will receive the intervention in-between these assessments. Thus, the time frame for data collection is 10 weeks. | Behavioural | one-arm, pre-post design |
Primary outcome
Acculturative Stress as measured by the Hispanic Stress Inventory-2
Time frame: 10 weeks
Hispanic Stress Inventory-2 is 24 item questionnaire asking about stress on a scale of 1 to 5, where 1 is not stressed and 5 is very stressed".
Perceived Stress as measured by the Perceived Stress Scale
Time frame: 10 weeks
The Perceived Stress scale is a 23-item questionnaire asking about stress on a scale of 1 to 5, where 1 is not stressed and 5 is extremely stressed.
Dispositional resilience as measured by the Resiliency Scale
Time frame: 10 weeks
Resilience scale is a 25-item questionnaire asking resilience on a scale of 1 to 7, where 1 is disagree and 7 is strongly agree.
Coping strategies as measured by the Brief COPE Scale
Time frame: 10 weeks
Brief COPE Scale is a 24-item questionnaire asking coping on a scale of 1 to 4, where is not at all and 4 is a lot.
Ethnic Identity as measured by the Multigroup Ethnic Identity Measure
Time frame: 10 weeks
MEI is a 12-item questionnaire asking about Hispanic identity on a scale of 1 to 7, where 1 is strongly disagree and 7 is strongly agree.
Familism as measured by Familism Scale.
Time frame: 10 weeks
Familism Scale is a 15 -item questionnaire asking about family welfare concern on a scale of 1 to 6, where 1 is strongly disagree and 6 is don't know.
Social Support as measured by Social Support Questionnaire
Time frame: 10 weeks
Social Support Questionnaire is 16-item questionnaire asking about social support on a scale of 1 to 5, where 1 is Never and 5 is always.
7 secondary outcomes
Anxiety symptoms as measured by GAD-7
Time frame: 10 weeks
Depression symptoms as measured by PHQ-9
Time frame: 10 weeks
Sleep Disturbance as measured by Sleep Disturbance
Time frame: 10 weeks
Drug Use as measured by Drug Abuse screening Test (DAST)
Time frame: 10 weeks
Self-reported Physical Health as measured by Physical activity.
Time frame: 10 weeks
Self-reported Physical Health as measured by Short Form Health Survey
Time frame: 10 weeks.
Self-reported Physical Health as measured by Self-Rated Health
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- 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.
Gabriela Nagy, Ph.D. principal investigator
Duke Health
Questions about this trial
What is this clinical trial studying?
A study testing intervention in adult Latinx immigrants in people with Acculturative Stress, run by Duke University.
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 3 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: withdrawn, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Acculturative Stress as measured by the Hispanic Stress Inventory-2 (time frame: 10 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2022.