N/A
N=64
Supporting Refugee and Immigrant Youth's Mental Health
Mental Health
Bottom Line
View on ClinicalTrials.gov: NCT05208359 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Strengths and Difficulties Questionnaire — 4.91; 3.49; 2.72; 2.72 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supporting Transition Resilience Of Newcomer Groups (STRONG) (Behavioral)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Loyola University Chicago
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Strengths and Difficulties Questionnaire |
4.91; 3.49; 2.72; 2.72; 4.05; 3.09 | — |
| SECONDARY Connor-Davidson Resilience Scale |
75.68; 72.08; 74; 75.27 | — |
| SECONDARY The Coping Efficacy Scale |
2.98; 3.09; 3.30; 3.14; 3.05; 3.10 | — |
| SECONDARY Responses to Stress Questionnaire |
2.63; 2.47; 2.70; 2.67; 2.08; 2.08 | — |
| SECONDARY School Connectedness Scale |
4.27; 4.11; 4.17; 4.08 | — |
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).
Aim 3: Examine implementation of STRONG across schools.
1. Investigators will conduct focus groups with clinicians and interviews with school personnel (teachers, administrators) to examine the challenges and successes related to implementation of STRONG. Qualitative thematic analysis will be conducted.
2. Satisfaction (clinician, parent, and student), student engagement with each session, and fidelity ratings will be examined.
Eligibility Criteria
Inclusion Criteria
- newcomer status (students who have migrated to a new country)
- difficulties in functioning or coping as assessed by school staff (teacher, school-based clinician).
Exclusion Criteria
- Born in mainland United States
Data sourced from ClinicalTrials.gov (NCT05208359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.