Supporting Refugee and Immigrant Youth's Mental Health

NCT05208359 | Completed Results

• 2 other identifiers: 2783R15MH128722
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Investigators hypothesize that these changes will be related to student mental health improvement/maintenance over time (mechanism of action).
3. 3.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.
4. 4.Satisfaction (clinician, parent, and student), student engagement with each session, and fidelity ratings will be examined.

Conditions

Mental Health

Outcome Measures

Primary Outcomes (1)

• Strengths and Difficulties Questionnaire

  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 points, with higher scores reflecting more problems (e.g., worse outcome).

  Baseline, 3 months, and 6 months

Secondary Outcomes (4)

• Connor-Davidson Resilience Scale

  Baseline, 3 months, and 6 months

• The Coping Efficacy Scale

  Baseline, 3 months, and 6 months

• Responses to Stress Questionnaire

  Baseline, 3 months, and 6 months

• School Connectedness Scale

  Baseline, 3 months, and 6 months

Study Arms (2)

STRONG immediate group

EXPERIMENTAL

Small mental health support group delivered immediately

Behavioral: Supporting Transition Resilience Of Newcomer Groups (STRONG)

STRONG delayed group

OTHER

Small mental health support group delivered after a delay of approximately 3 months

Behavioral: Supporting Transition Resilience Of Newcomer Groups (STRONG)

Interventions

Supporting Transition Resilience Of Newcomer Groups (STRONG) BEHAVIORAL

10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth

STRONG delayed group; STRONG immediate group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• newcomer status (students who have migrated to a new country)
• difficulties in functioning or coping as assessed by school staff (teacher, school-based clinician).

You may not qualify if:

• Born in mainland United States

Sponsors & Collaborators

• Loyola University Chicago: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Loyola University Chicago

Chicago, Illinois, 60660, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Sungha Kang
• Organization: Loyola University Chicago

skang@luc.edu

7735082712

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 26, 2022
• Study Start: November 4, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data has been deposited in NIMH Data Archive.
• Access Criteria: Accessible via NIMH Data Archive

Locations

US (1)