Stress ReductionAERNCT06786741
Afghan Evacuee Resettlement for Stronger Communities (AER)
A study testing AER for Stronger Communities in people with Stress Reduction and Healthy Relationships, run by Loyola University Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Reduction, Healthy Relationships, Emotional Wellbeing
- What is being tested?
- AER for Stronger Communities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 18 years old or older, resettled to US post-2021 from Afghanistan
- speaks English or Dari
- has access to smart phone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Responsive Intervention Incorporating AI to Promote Healthy Integration Among Afghan Evacuees in Illinois and Tennessee (Pilot Study)
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.
Read the detailed description
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 platform 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 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.
The project is closely aligned with the priorities of the Schreiber Venture Fund that funded the pilot testing. Ultimately, findings will also lay the foundation for a future R01 NIH grant and have transdisciplinary implications.
- Conditions
- Stress Reduction, Healthy Relationships, Emotional Wellbeing
- Being tested
- AER for Stronger Communities, Placebo Comparator
- Keywords
- evacuees, Afghan, stress, culturally responsive, integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AER for Stronger CommunitiesBehavioural
3 week rapid intervention aimed at reducing stress.
Placebo ComparatorOther
3 week short video program (control)
| Study group | Role | What they receive |
|---|---|---|
| AER Intervention | Experimental | Intervention participants are provided with a 3 week rapid intervention. Receives: Behavioral: AER for Stronger Communities |
| Control | Placebo comparator | Control participants are provided access to short videos across the same 3 week period. Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0, 1, 2,3, 4-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start5 Sep 2024
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786741
- Sponsor's protocol ID
- Project# 3964
- Acronym
- AER
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Responsive Intervention Incorporating AI to Promote Healthy Integration Among Afghan Evacuees in Illinois and Tennessee (Pilot Study)
- ClinicalTrials.gov ID
- NCT06786741
- Acronym / sponsor ID
- AER / Project# 3964
- Conditions
- Stress Reduction, Healthy Relationships, Emotional Wellbeing
- Keywords
- evacuees, Afghan, stress, culturally responsive, integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Loyola University ChicagoUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 platform 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 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.
The project is closely aligned with the priorities of the Schreiber Venture Fund that funded the pilot testing. Ultimately, findings will also lay the foundation for a future R01 NIH grant and have transdisciplinary implications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AER Intervention | Experimental | Behavioral: AER for Stronger CommunitiesIntervention participants are provided with a 3 week rapid intervention. |
| Control | Placebo comparator | Other: Placebo ComparatorControl participants are provided access to short videos across the same 3 week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AER for Stronger Communities3 week rapid intervention aimed at reducing stress. | Behavioural | AER Intervention |
| Placebo Comparator3 week short video program (control) | Other | Control |
Primary outcome
Stress reduction
Time frame: Weeks 0, 1, 2,3, 4-week follow up
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.
Integration
Time frame: Weeks 0, 1, 3, 4-week follow up
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.
Healthy Relationships
Time frame: Weeks 0, 2, 3, 4-week follow up
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.
Emotional Wellbeing
Time frame: Weeks 0, 3, 4-week follow up
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.
Psychological distress
Time frame: Weeks 0, 1, 2,3, 4-week follow up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AER for Stronger Communities in people with Stress Reduction and Healthy Relationships, run by Loyola University Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress reduction (time frame: Weeks 0, 1, 2,3, 4-week follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.