Acculturative Stress Intervention (REACH Equity CDA)

NCT04785339 | Withdrawn

• 1 other identifier: Pro00105969
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acculturative Stress

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• 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

Study Arms (1)

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.

Behavioral: intervention in adult Latinx immigrants

Interventions

intervention in adult Latinx immigrants BEHAVIORAL

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.

one-arm, pre-post design

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Gabriela Nagy, Ph.D.

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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).

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: June 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 28, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share