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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05208359
Study type Interventional
Source Loyola University Chicago
Contact Catherine Santiago, PhD
Phone 773-508-2712
Email [email protected]
Status Recruiting
Phase N/A
Start date November 4, 2021
Completion date July 1, 2024

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