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NCT05208359 · ClinicalTrials.gov registry record · NA

Supporting Refugee and Immigrant Youth's Mental Health

A NA study, sponsored by Loyola University Chicago.

Completed
Registry status
NA
Development phase
64
Enrollment target

NCT05208359: Completed NA study, sponsored by Loyola University Chicago.

NCT05208359 is a NA study that has completed, run by Loyola University Chicago. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05208359, a NA study, has completed, sponsored by Loyola University Chicago.

COMPLETED
Registry status
NA
Development phase
64 participants
Enrollment target

Study Summary

The purpose of this study is to examine the effectiveness of STRONG on the mental health of refugee and immigrant students using a group randomized waitlist control design (e.g., randomization by school/group). Further, the impact of STRONG on key target mechanisms (e.g., resilience, coping, and school connectedness) are also examined. Finally, investigators examine the implementation of STRONG to guide additional dissemination. School-based mental health clinicians will co-facilitate STRONG groups in schools, meeting once a week. STRONG will be implemented in six public schools across two academic years. In each school, one group of approximately five students will be implemented, resulting in a sample of 60 students total across the two years. Schools will be randomly assigned to either provide the STRONG program immediately (immediate treatment) or after three months (delayed treatment). A team of 10 undergraduate students and four graduate students will collect data at baseline and at three- and six-months post baseline. Aim 1: Evaluate impact of STRONG on student mental health via randomized waitlist control design. 1\) Investigators hypothesize that students who participate in STRONG will show improvements in self-reported, parent-reported, and teacher-reported mental health (emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems) as compared to the waitlist control group (primary outcome). Aim 2: Examine the impact of STRONG on resilience, coping, and school connectedness and how these changes are related to student mental health outcomes. 1. Investigators hypothesize that students who participate in STRONG will show improvements in self-reported resilience, coping efficacy, school connectedness, and parent-reported coping as compared to the waitlist control group (target mechanisms). 2. Investigators hypothesize that these changes will be related to student mental health improvement/maintenance over time (mechanism of action).

Primary Outcome

The Stress and Difficulties Questionnaire is a 25-item (e.g., "I worry a lot") questionnaire with four subscales: emotional symptoms, conduct problems, hyperactivity/inattention problems, and peer problems. Participants answer on a 3-point Likert scale (0 = "Not at All" to 2 = "Certainly True"). Externalizing Problems are the sum of the conduct problems and hyperactivity scales. Internalizing Problems are the sum of emotional symptoms and peer problems. Scales mean range from 0 to 20 total point

Interventions

  • BEHAVIORAL Supporting Transition Resilience Of Newcomer Groups (STRONG)

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2021-11-04
Est. Completion 2023-07-01
Phase NA
Loyola University Chicago

4 total trials

What the finished NCT05208359 record still lists

NCT05208359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Supporting Transition Resilience Of Newcomer Groups (STRONG) is the first listed.

NCT05208359 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05208359 about?

NCT05208359 is a clinical study titled "Supporting Refugee and Immigrant Youth's Mental Health". The purpose of this study is to examine the effectiveness of STRONG on the mental health of refugee and immigrant students using a group randomized waitlist control design (e.g., randomization by school/group). Further, the impact of STRONG on key target mechanisms (e.g., resilience, coping, and sch...

What is the current status of trial NCT05208359?

This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2021-11-04. Estimated completion is 2023-07-01.

What interventions are being tested in trial NCT05208359?

The interventions under investigation include: Supporting Transition Resilience Of Newcomer Groups (STRONG) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05208359?

This trial is sponsored by Loyola University Chicago, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05208359's enrollment target sits among peer trials

64 1147th of 2000 higher than 844 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05208359, the US trial registry maintained by the National Library of Medicine. NCT05208359 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.