Clinical trial NCT04785339: Acculturative Stress Intervention (REACH Equity CDA)
Official title: Latinx Acculturative Stress Intervention Development and Implementation (REACH Equity CDA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acculturative Stress
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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)

Primary outcomes:
measure: Acculturative Stress as measured by the Hispanic Stress Inventory-2
timeFrame: 10 weeks
measure: Perceived Stress as measured by the Perceived Stress Scale
timeFrame: 10 weeks
measure: Dispositional resilience as measured by the Resiliency Scale
timeFrame: 10 weeks
measure: Coping strategies as measured by the Brief COPE Scale
timeFrame: 10 weeks
measure: Ethnic Identity as measured by the Multigroup Ethnic Identity Measure
timeFrame: 10 weeks
measure: Familism as measured by Familism Scale.
timeFrame: 10 weeks
measure: Social Support as measured by Social Support Questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: Anxiety symptoms as measured by GAD-7
timeFrame: 10 weeks
measure: Depression symptoms as measured by PHQ-9
timeFrame: 10 weeks
measure: Sleep Disturbance as measured by Sleep Disturbance
timeFrame: 10 weeks
measure: Drug Use as measured by Drug Abuse screening Test (DAST)
timeFrame: 10 weeks
measure: Self-reported Physical Health as measured by Physical activity.
timeFrame: 10 weeks
measure: Self-reported Physical Health as measured by Short Form Health Survey
timeFrame: 10 weeks.
measure: Self-reported Physical Health as measured by Self-Rated Health
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Duke Health
name: Gabriela Nagy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: