Viewing Study NCT04785339



Ignite Creation Date: 2024-05-06 @ 3:52 PM
Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04785339
Status: WITHDRAWN
Last Update Posted: 2022-07-28
First Post: 2021-03-03

Brief Title: Acculturative Stress Intervention REACH Equity CDA
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: Latinx Acculturative Stress Intervention Development and Implementation REACH Equity CDA
Status: WITHDRAWN
Status Verified Date: 2021-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: PI is leaving institution
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: REACH Equity
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 N24-30to evaluate its preliminary clinical impact from baseline to post-assessment on stress resilience and health outcomes eg 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 n8-10

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None