Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05208359 |
| Other study ID # |
2783 |
| Secondary ID |
R15MH128722 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 4, 2021 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Loyola University Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
