Supporting Refugee and Immigrant Youth's Mental Health

June 24, 2025 updated by: Loyola University Chicago

Supporting Refugee and Immigrant Youth's Mental Health: Examining Effectiveness and Implementation of a School-Based Intervention

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.

Study Overview

Detailed Description

STRONG will be implemented in six public schools during 2021-2022 academic year and six public schools during the 2022-2023 academic year. Investigators anticipate three elementary schools and three high schools each year. Within CPS, school leadership has requested interventions specifically designed for refugee and immigrant students due to school population and need. In each school, one group of approximately five students will be implemented. Schools will be randomly assigned to either provide the STRONG program immediately (immediate treatment) or after three months (delayed treatment). Randomization will include balancing of elementary and high schools so that the number of elementary and high schools randomized to immediate vs. delayed treatment will be equivalent. School mental health staff (e.g., district-employed social workers or community clinicians who provide services in schools) will co-facilitate groups in schools, meeting once a week. School-based clinicians are typically expected to deliver one to two small group interventions as part of their job duties. District partners have committed to supporting clinicians in delivering STRONG as part of this expectation. The research team, comprised of 10 undergraduate students and four graduate students, will collect data at baseline and then at three- and six-months post baseline. Undergraduate and graduate student pairs will meet with students and parents at schools allowing for support and mentorship of undergraduate research assistants along with clinical expertise from graduate students enrolled in the Clinical Psychology PhD program at Loyola University Chicago.

Eligibility Criteria Students will be identified by trained STRONG clinicians consistent with standard school procedures, which include teacher and other school staff referral, parent nomination, and clinician identification from other support services. Eligibility criteria include (1) newcomer status (students who have migrated to a new country) and (2) difficulties in functioning or coping as assessed by school staff (teacher, school-based clinician). Referral reasons may include general difficulties, academic performance, peer relationships, family relationships, physical problems, behavioral concerns, and/or appearance of affect, among others. The eligibility criteria are intentionally designed to be broad (i.e., not a strict clinical cutoff) with the purpose of being more inclusive, understanding that cultural and environmental differences may produce different behavioral and emotional outcomes than what typical clinical assessments capture. In addition, researchers call for mental health treatment for refugee and immigrant children that can address trauma, acculturation, isolation, and resettlement, to better address needs. Due to the diversity in experiences, this can also impact the presenting concerns of children during the resettlement process. Thus, it is important to have a broader inclusion criterion to best fit the needs of this group. This way children that may not be presenting with solely PTSD symptoms, including anxiety, depression, and stress management problems can also benefit from a mental health intervention that highlights their strengths. STRONG allows for this flexibility needed in addressing presenting concerns among this diverse population.

Intervention Training for clinicians to implement STRONG will occur in fall 2021. Training will be facilitated by the Center for Childhood Resilience (CCR) at Lurie Children's Hospital. The STRONG training is two days and provides an overview of each session, practice of strategies, and implementation planning. STRONG includes 10 small group sessions, one individual session (for journey narrative), and teacher and parent education sessions. There is an elementary and high school version of the manual, modified for developmental appropriateness (Hoover et al., 2019). Group sessions include recognizing internal strengths, identifying family/social supports, relaxation, mindfulness, cognitive coping, and problem-solving. Each session includes newcomer-specific examples and support for students in applying strategies to their newcomer experience as well as natural opportunities to foster positive identity and build on strengths.

In the elementary and high school groups, session one helps students identify internal strengths and external support systems (family/social supports), while in session two students learn about stress and how it impacts their bodies and minds. In the third session, stress reactions and feeling identifications are explored, and in the fourth session feelings management is discussed. In session five, students begin the session by sharing an object that represents where they are from, fostering positive cultural identity. Then, students begin to explore the cognitive aspect of mental health and learn about using helpful thoughts. In session six, children learn about the "steps to success", in which they create goals and manageable steps to achieve them, as well as ways to address avoidance. In session seven, children are taught different strategies for problem solving. In session eight, students share something meaningful from their home country (e.g., favorite food, special place, favorite tradition) and then share parts of their journey with the group. In the ninth session, students share about a favorite holiday or tradition and then continue sharing about their journeys. Then in session 10, students take turns appreciating strengths they have noticed about group members and then take part in a graduation celebration. Between sessions four and eight, students meet individually with the clinician to discuss their journey to the U.S. This may include positive and difficult experiences, including potential traumatic experience. The clinician guides students to recognize strengths that helped them get through their journey rather than focusing on a single event with repeated retelling. The journey narrative is flexible to allow students to discuss multiple traumatic experiences, while also highlighting strengths and assets. It is recommended that the clinician screen for significant PTSD symptoms in individual sessions to consider if additional referrals will be necessary after STRONG. Clinicians also have individual sessions with caregivers and teachers to provide psychoeducation on the children's participation in the STRONG program. This allows for caregivers and teachers to support the student's progress in multiple settings.

Participants An estimated 60 students will participate in STRONG (five students per group across six public schools over two years). Student age range will be 8-18, though each STRONG group will be comprised of students within one grade level of each other. Clinicians, school personnel (teachers, administrators), and parents will be invited to complete measures and participate in focus groups (clinicians) or interviews (teachers, administrators). Teachers who have students participating in STRONG and/or assisted with referrals/identification of students will be recruited to participate in interviews. Teacher participants will be identified in collaboration with school partners/administrators. For example, English Language Learner (ELL) teachers have been key partners in referrals/identification of students in our preliminary feasibility pilot.

Procedure Clinicians will identify eligible students and reach out to parents/caregivers consistent with standard school procedures. Clinicians will offer a group or individual information meeting to share more about STRONG and will ask parent permission to share contact information with the research team. With permission, the research team will meet with parents as part of the informational meeting or at a later date to provide additional information about the research protocol and obtain informed consent and assent.

Data will be collected from students, parents, and teachers at baseline and then at three- and six-months post baseline. Questionnaires will include measures of emotional/behavioral symptoms as well as coping and resilience. Caregivers will also be asked to provide demographic information. The three-month assessment point will represent "post-intervention" data for students at schools randomized to immediate treatment, and will be a second "pre-intervention" time-point for students at schools randomized to delayed treatment. The six-month assessment will represent three-month follow-up data for students at schools randomized to immediate treatment and "post- intervention" data for students at schools randomized to delayed treatment. School-based mental health staff will complete fidelity monitoring forms after each session, and will provide quantitative and qualitative feedback on their satisfaction with the program.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60660
        • Loyola University Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STRONG immediate group
Small mental health support group delivered immediately
10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
Other: STRONG delayed group
Small mental health support group delivered after a delay of approximately 3 months
10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strengths and Difficulties Questionnaire
Time Frame: Baseline, 3 months, and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Connor-Davidson Resilience Scale
Time Frame: Baseline, 3 months, and 6 months
Connor-Davidson Resilience Scale is a 25-item measures that measures adaptability and resilience among youth. Participants rated each item on a 5-point Likert scale (0= "Not True at All" to 4 = "True Nearly All of Time"). Total scores range from 0 to 100, with higher scores indicating more adaptability and resilience (e.g., better outcome).
Baseline, 3 months, and 6 months
The Coping Efficacy Scale
Time Frame: Baseline, 3 months, and 6 months
The Coping Efficacy Scale (Sandler et al., 2000) measures an individual's belief in their ability to use coping strategies to handle future stressors and novel situations. For this study, six items designed to assess both satisfaction with past coping efforts and anticipated effectiveness in handling future problems were included. The scale uses a 4-point scale (1= "Not At All" to 4 = "Well"), with higher scores indicating greater coping efficacy (e.g., better outcome).
Baseline, 3 months, and 6 months
Responses to Stress Questionnaire
Time Frame: Baseline, 3 months, and 6 months
The Responses to Stress Questionnaire (RSQ) is a 57-item multidimensional measure on 4-point Likert scale (1= "Not at all" to 4 = "A lot"). Primary control, secondary control, and disengagement coping factors were used in this study. With higher mean scores reporting higher coping in each respective factor. Mean scores were used.
Baseline, 3 months, and 6 months
School Connectedness Scale
Time Frame: Baseline, 3 months, and 6 months
The School Connectedness Scale is a 5-item questionnaire that measures youth's bond toward their school on a 5-point Likert scale (1="Strong Disagree" to 5="Strongly Agree"). Mean scores were used in analysis, with higher scores indicating higher school connectedness (e.g., better outcome).
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2783
  • R15MH128722 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data have been deposited into NIMH Data Archive.

IPD Sharing Time Frame

The data has been deposited in NIMH Data Archive.

IPD Sharing Access Criteria

Accessible via NIMH Data Archive

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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