Acculturative Stress Intervention (REACH Equity CDA) (REACH Equity)

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.

Study Overview

• Status: Withdrawn
• Conditions: Acculturative Stress
• Intervention / Treatment: Behavioral: intervention in adult Latinx immigrants

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one-arm, pre-post design; 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.	Behavioral: intervention in adult Latinx immigrants; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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.	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.	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.	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.	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.	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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	10 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Gabriela Nagy, Ph.D., Duke Health

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro00105969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No