NCT06786741

Brief Summary

Background. Under Operation Allies Welcome, approximately 88,500 Afghan evacuees have resettled in the United States (US). Evacuees face unique integration, well-being, and mental health challenges. Settlement is nationwide, including key locations of Illinois (IL) and Tennessee (TN). Study aims. In the proposed study, investigators will pilot test a 3-week culturally responsive and flexible, sprint (rapid) intervention, AER (Afghan Evacuee Resettlement) for Stronger Communities, with Afghan evacuees in IL and TN. A beta version of the first-ever AI platform, Dost, for Afghan evacuees will also be tested. Innovation. This is the first flexible and culturally responsive intervention and AI app created for Afghan evacuees to be delivered in English and Dari. Up-to-date data from evacuees over the past year inform this intervention. Methods. To pilot test the intervention, a randomized control trial (RCT) with an optional waitlist will be conducted with approx. 50-60 evacuees across IL and TN. Community liaisons from partner agencies will also be recruited for intervention delivery. Participants in the intervention group will also be able to access the AI platform. Evacuees and liaisons will be invited to provide feedback on the intervention and evacuees will be invited to provide feedback on the platform. Expected results. Investigators expect to test the central hypothesis of the study, that individuals who receive the sprint intervention and access the AI platform will have reduced stress outcomes (integration, social relationships, and mental health) compared to those who do not. Impact. Findings will build new evidence for migrants in Chicago and nationally. This project will also further interdisciplinary collaboration across Loyola University Chicago and beyond.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 10, 2025

Last Update Submit

January 23, 2025

Conditions

Keywords

evacueesAfghanstressculturally responsiveintegration

Outcome Measures

Primary Outcomes (5)

  • Stress reduction

    Reduced stress as measured by PSS-4 instrument (0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often \*some scoring and questions were modified to make them culturally responsive.

    Weeks 0, 1, 2,3, 4-week follow up

  • Integration

    IPL Integration Index (1 to 5, 1 low, and 5 is high); Economic self-efficacy (1=strongly disagree, 2=disagree, 3=neutral, 3=agree, 5=strongly agree) \*some scoring and questions were modified to make them culturally responsive.

    Weeks 0, 1, 3, 4-week follow up

  • Healthy Relationships

    Healthy relationships as measured by Relationship Assessment Scale (1=low, 2, 3, 4, 5=high); Brief Family Relationship Scale (1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree); Gender role beliefs scale (1=strongly agree, 2=moderately agree, 3=slightly agree, 4=undecided, 5=slightly disagree, 6=moderately disagree, 7=strongly disagree. \*some scoring and questions were modified to make them culturally responsive.

    Weeks 0, 2, 3, 4-week follow up

  • Emotional Wellbeing

    Emotional wellbeing as measured by Post-migration stress scale (1=never, 2=seldom, 3=sometimes, 4=often, 5=very often), brief Cope inventory (1=haven't been doing this at all, 2=been doing a little bit, 3=doing this a medium amount, 4=doing this a lot) \*some scoring and questions were modified to make them culturally responsive.

    Weeks 0, 3, 4-week follow up

  • Psychological distress

    Kessler-6 to measure psychological distress (1=all of the time, 2=most of the time, 3=some of the time, 4=a little of the time, 5=none of the time) \*some scoring and questions were modified to make them culturally responsive.

    Weeks 0, 1, 2,3, 4-week follow up

Study Arms (2)

AER Intervention

EXPERIMENTAL

Intervention participants are provided with a 3 week rapid intervention.

Behavioral: AER for Stronger Communities

Control

PLACEBO COMPARATOR

Control participants are provided access to short videos across the same 3 week period.

Other: Placebo Comparator

Interventions

3 week rapid intervention aimed at reducing stress.

AER Intervention

3 week short video program (control)

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
1. 18 years old or older, resettled to US post-2021 from Afghanistan 2. speaks English or Dari 3. has access to smart phone.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Loyola University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Aerosols

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 22, 2025

Study Start

September 5, 2024

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations