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Clinical Trials/NCT04785339
NCT04785339
Withdrawn
Not Applicable

Latinx Acculturative Stress Intervention Development and Implementation (REACH Equity CDA)

Duke University0 sitesJune 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acculturative Stress
Sponsor
Duke University
Primary Endpoint
Acculturative Stress as measured by the Hispanic Stress Inventory-2
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief 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, 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).

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
December 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old,
  • Latinx/Hispanic Self identifying
  • Immigrant (born outside of the US)

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Anxiety symptoms as measured by GAD-7(10 weeks)
  • Depression symptoms as measured by PHQ-9(10 weeks)
  • Sleep Disturbance as measured by Sleep Disturbance(10 weeks)
  • Drug Use as measured by Drug Abuse screening Test (DAST)(10 weeks)
  • Self-reported Physical Health as measured by Physical activity.(10 weeks)
  • Self-reported Physical Health as measured by Short Form Health Survey(10 weeks.)
  • Self-reported Physical Health as measured by Self-Rated Health(10 weeks)

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