Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06153316 |
| Other study ID # |
21-419 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Teachers College, Columbia University |
| Contact |
Sonali Rajan |
| Phone |
212-678-3458 |
| Email |
sr2345[@]tc.columbia.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study hypothesize that school safety strategies may contribute to poor mental health and
distress among various school populations and proposes the following research questions to be
answered through this study:
1. Is there a significant difference in the prevalence of mental health outcomes, perceived
school safety, and academic engagement between early adolescent and adolescent students
(grades 6 - 12) at schools that have experienced a school shooting and those that have
not?
2. Are existing interventions to promote school safety and security associated with poor
mental health outcomes among students and school staff?
3. Does the strength of this association between school safety interventions and mental
health outcomes differ among students and teachers in those schools who have experienced
a school shooting versus among students and teachers in those schools who never
experienced a school shooting? And, among our sample of students, are these associations
moderated by their ACE history? Participants will be asked to self-report data on their
mental health and wellness, and perceived school safety through a survey.
Researchers will compare the surveys from the participants from exposure schools (those who
experienced a gun shooting incident) with surveys from the participants from non-exposure
schools (those who have not experienced a gun shooting incident)
Description:
The recent increase in school gun violence is an important cause of poor mental health and
adverse childhood experiences (ACEs) among the school going populations. Schools have
implemented a number of school safety and security measures, both in response and
anticipation of gun violence. Some of these interventions increase anxiety, depression, and
other indicators of poor mental health among students and staff alike. Despite this, the
association between exposure to existing school safety interventions and early adolescent
student mental health outcomes has yet to be investigated. This observational case-control
study aims to understand this association by collecting cross-sectional surveys from
students, teachers, staff, and principals across a sample of 12 nationally representative
K-12 public schools in the United States.
Data Collection
Primary data collection- Among the participating schools, data will be collected through
surveys prepared for students, teachers, and principals separately. Completing each survey
will take about 25 minutes for the students, and 15-20 minutes for the teachers and
principals. The student surveys will be administered by the research team in the classroom on
a school day. Similarly, the teacher surveys will be administered on the school day. The
principals' survey will be administered online via Qualtrics.
These surveys will collect the following information from each participant:
Demographics: Data on sex, race, age, grade-level, and presence at the time of the school
shooting incident for students in the exposure school.
Mental health and well-being: Among the participating students in each school, self-report
data on mental health and well-being will be assessed via a survey that comprises 1) eight
items from the Patient Health Questionnaire (PHQ) - A, a validated and widely used survey
assessing mental health and symptoms of depression among youth; 2) 25 items from the Child
and Adolescent Trauma Screen (CATS), which has been validated for use by youth ages 7-17
years; and 3) five items from the World Health Organization (WHO-5) Well-Being Index, which
has been validated for use by individuals ages 9 years and older. The PHQ-A and CATS items
are multiple choice with four response options, and the WHO-5 items are rated on a 6-point
Likert scale.
Among the participating teachers in each school, self-report survey data on mental health and
well-being will be assessed via a) eight items from the PHQ - 9, a validated survey assessing
mental well-being and symptoms of depression among adults, b) the Generalized Anxiety
Disorder 7-item (GAD-7) scale, which has also been validated and assesses the most common
anxiety disorders among adults, and c) via five items from the WHO-5 well-being index. The
PHQ-9 and GAD-7 items are multiple choice with four response options and the WHO-5 items are
rated on a 6-point Likert scale.
ACE prevalence: Each student will provide self-report data on ACE prevalence. Ten of these
items were adapted in previous research from a validated tool. Building upon additional
research that has argued that children experience a greater range of adversity than most ACE
assessments currently capture an additional five items will be included. The survey will
therefore assess the following: bullying, residential instability, Child Protective Services
(CPS) involvement, meeting of basic needs, parents divorced, death of a primary caregiver,
family member with poor mental health, family member engaging in substance use, domestic
violence, incarcerated parent, community violence, death of friend(s), experience with the
foster care system, experience with the juvenile justice system, and exposure to violence in
school. Each item will be multiple choice, with the following response options: "yes", "no",
or "prefer not to answer" and these data will comprise an ACE prevalence score that denotes
how many ACEs each student has experienced.
Perceptions of school safety: The "Safe and Responsive Schools" Safe School Survey is a
validated tool designed to be administered to students and school staff. This instrument
assesses six critical constructs, including perceptions of school climate, school safety, and
belongingness. In line with previous research on school violence and in an effort to
comprehensively assess perceptions of school safety, this tool seeks to capture both minor
conflicts (e.g., arguments among students) as well as more significant forms of disruption
(for example, weapon possession on school grounds).
Educational outcomes: Among the participating students in each school, self-report survey
data on academic engagement will be assessed via the Student Engagement Instrument (SEI). The
SEI is a 35-item survey that assesses multiple academic constructs, including extrinsic
motivation to learn, future goals and aspirations, class participation, teacher-student
relationships, and perceived peer support for learning. The survey also includes one
multiple-choice item that has been adapted from the CDC's Youth Risk Behavioral Surveillance
System (YRBSS) and that asks students to describe their academic grades in schools over the
past 12 months.
School safety and security strategies: Data on school safety and security strategies from the
following seven categories will be collected- 1) external target hardening efforts (e.g.
monitored school entry doors; signs indicating the school is a "Gun Free School Zone"), 2)
internal target hardening efforts (e.g., metal detectors; security cameras); 3) student/staff
monitoring (e.g. threat assessment team; zero-tolerance policies for weapons) 4) emergency
procedures/drills (e.g., written active shooter plan); 5) emergency notification technologies
(e.g., anonymous thread reporting systems; panic buttons); 6) medical support (e.g., full or
part-time school nurse on campus); and 7) school security staff (e.g., law enforcement
officers or police; teachers and/or other personnel armed with guns).
This data will be collected in two ways- One, principals from all participating schools will
be surveyed on their knowledge of current school safety tactics and policies. Second, the
researchers will review each school's current school safety plan, which is a comprehensive
document developed by school stakeholders that details preparation and response protocols to
various school emergencies.
Independent Covariates. Data on multiple independent covariates will also be collected via
sources like the National Center for Education Statistics (NCES) and the U.S. Census and
adjusted for in conditional logistic regression models. These covariates will include the
length of time since the school experienced a shooting; demographics (e.g., urbanicity,
school level, and type of school); and school district characteristics. In addition,
secondary data on education access, equity, and school discipline will be directly downloaded
from the Civil Rights Data Collection website. Using these recent data on each participating
school, the study team will create a "school discipline" summative score that will comprise
the following indicators (accounting for school population size and reflecting the number per
academic year): attendance rate, number of in-school suspensions, out-of-school suspensions,
students referred to law enforcement, students disciplined for harassment or bullying, and
school-related arrests. Propensity score match and control statistical methods will be used
to ensure rigor in association validity controlling for these characteristics
comprehensively.
Human Subjects Protection This study protocol has been approved by the Institutional Review
Boards (IRB) at Columbia University Medical Center and Teachers College, Columbia University.
The survey data collected from students, teachers, and school staff will be confidential, but
not anonymous. All participants will be associated with a specific school. However, no
identifying names or other identifiers will be used at any point in the study. Each
participant will be identified solely via an alphanumeric code during the data collection and
organization process.
Data Organization and Treatment
Survey data entry: All survey data collected in this study are being recorded initially in
Microsoft Excel for organization and management and then subsequently read into SPSS (version
28.0) for analysis. The study team maintains a codebook; where needed, variables will be
recoded and summative scores computed.
Document review: Each school safety plan will be reviewed and coded independently by two
members of our research team to determine if each of the school safety strategies and tactics
of interest are being implemented. These data will also be recorded initially in Microsoft
Excel for organization and management and then subsequently read into SPSS for analysis.
Missing data: Consistent with previous research, we estimate the majority of survey items to
have less than 10% missing data and no more than 19% missing survey data on any given item.
However, should higher levels of missing data occur, multiple imputation methods will be
used.
Data Analysis Plan The data collected from the students, teachers, and principals across all
12 participating schools will be analyzed and will fully respond to each of the research
questions. Descriptive statistics will be calculated to summarize student and teacher
participant characteristics within each school and also describe each school's safety and
security strategies. Analyses of Covariance (ANCOVAs) will subsequently be used to identify
potential significant differences in the prevalence of mental health and well-being,
perceptions of school safety, educational outcomes, and ACEs between students in schools who
have more recently experienced an intentional school shooting (nAnticipatedRange(AR) =
375-600), schools who have experienced an intentional school shooting less recently (nAR =
375-600), and schools who have never experienced a shooting (nAR = 750-1200), while
controlling for key covariates.
Analyses of Variance (ANOVAs) will also be used to identify potential significant differences
in the prevalence of mental health and perceptions of school safety between teachers in
schools who have more recently experienced an intentional school shooting (nAR = 15-30),
schools who have experienced an intentional school shooting less recently (nAR = 15-30), and
schools who have never experienced an intentional school shooting (nAR = 30 -60). The
research team utilized G*Power (v.3.1) to run power analyses in anticipation of the proposed
analyses, assuming an alpha-level of .05 and a power of 0.80. In the case of the proposed
student analyses, a very small minimum effect size will need to be detected to meet the power
requirements and given the anticipated minimum sample size. In the case of the teacher
analyses, a medium effect size will need to be detected.
Multiple regression analyses will then be used to determine if the strength of the
association between school safety interventions and mental health outcomes differs among
students and school staff in schools with varying levels of trauma exposure. Mediated
moderation analyses will evaluate the role of ACEs on the relationship between exposure to an
intentional school shooting, exposure to school safety strategies, and student outcomes
(mental health and well-being, perceptions of school safety, and educational outcomes).
Again, power analyses revealed that for the student-level analyses and given an alpha-level
of .05 and a power of 0.80, a small effect size will need to be detected in order to meet the
power and sample size requirements. In the case of the proposed teacher analyses, a medium
effect size will need to be detected.
Potential Study Challenges The researchers have identified some potential challenges this
study may face and their possible solutions. Being a survey, the study requires voluntary
participation from the students, teachers, and principals of the 12 selected schools. The
participation will be encouraged by prioritizing confidentiality, reducing the time burden
associated with the study, creating an accessible survey questionnaire, and creating an
inclusive study environment by ensuring that all participants have regular opportunities to
ask questions and express concerns throughout the study process. We will also be providing
incentives to all participating schools to recognize their time spent on this study.
Other potential risks include the possibility of emotional responses that may emerge during
the data collection process. The research team will take great care to ensure that the
proposed data collection effort takes place in a manner that is comfortable and safe for all
participants. It should be noted that this study will not be collecting data on self-harm or
suicidality.
Finally, there is the possibility of missing survey data; however, the use of multiple data
sources where possible and multiple imputation methods will address the problem of missing
data during the data analysis process.
