Pregnancy Related Clinical Trial
Official title:
Rigorous Evaluation of High School FLASH
High School FLASH is a 15-session comprehensive sexual health curriculum designed for classroom settings in grades 9 to 12. The basis of High School FLASH is a public health approach to behavior change. The primary strategy used in the FLASH curriculum for preventing teen pregnancy, sexually transmitted diseases (STDs), and sexual violence is to address student behaviors and attitudes. To this end, FLASH uses a harm reduction and behavior change framework, implements best practices as outlined in the research on effective programs, addresses risk and protective factors for program goals, and rests on the theory of planned behavior. The instructional approach of High School FLASH employs key concepts in every lesson, which enables teachers to hone in on the risk and protective factors outlined in the curriculum logic model. The curriculum covers the following topics: reproductive system, pregnancy, sexual orientation and gender identity, healthy relationships, coercion and consent, online safety, abstinence, birth control, preventing human immunodeficiency virus (HIV) and other STDs, condoms, STD testing, communicating and decision making, and improving school health. The curriculum aligns with national health education standards.
High School FLASH is a 15-session comprehensive sexual health curriculum designed for
classroom settings in grades 9 to 12. The basis of High School FLASH is a public health
approach to behavior change. The primary strategy used in the FLASH curriculum for preventing
teen pregnancy, sexually transmitted diseases (STDs), and sexual violence is to address
student behaviors and attitudes. To this end, FLASH uses a harm reduction and behavior change
framework, implements best practices as outlined in the research on effective programs,
addresses risk and protective factors for program goals, and rests on the theory of planned
behavior. The instructional approach of High School FLASH employs key concepts in every
lesson, which enables teachers to hone in on the risk and protective factors outlined in the
curriculum logic model. The curriculum covers the following topics: reproductive system,
pregnancy, sexual orientation and gender identity, healthy relationships, coercion and
consent, online safety, abstinence, birth control, preventing human immunodeficiency virus
(HIV) and other STDs, condoms, STD testing, communicating and decision making, and improving
school health. The curriculum aligns with national health education standards. FLASH is
ideally taught 2-5 times per week for 15 sessions lasting 50 minutes, or 10 sessions lasting
70-80 minutes, covering the same content. The curriculum is designed to be flexible to ensure
sustainability in a variety of school environments.
The counterfactual condition is called Sexual Health Education for Adolescents, which is a
five-session knowledge-based sexual health curriculum designed for classroom settings. The
lessons cover the reproductive system, pregnancy, birth control, abstinence, HIV and other
STDs, and healthy relationships. The goal of the curriculum is to increase student knowledge
in all content areas. The primary strategy employed by Sexual Health Education for
Adolescents is to address the cognitive learning domain. The curriculum aligns to national
health education standards and is intended to be implemented by classroom teachers. The
lessons can be delivered according to the schedule that works best for schools (e.g., twice a
week, once a week, every days) within a school semester.
Students were recruited from 9th (South) or 10th (Midwest) grade health classes. The research
team met with district and school administrators and health teachers to explain the study,
data collection processes, and to answer questions. The FLASH study enrolled students from
required health classes from 20 schools in the South and the Midwest. In the Midwest, we
worked with two districts; one of the districts contributed 9 of the 10 high schools and the
other district contributed one high school to the evaluation study. In the South, we have
partnered with 10 schools in 5 counties, representing 5 different districts. One of these
districts contributed 6 schools to the evaluation study and the remaining 4 districts each
contributed 1 high school to the study.
Randomization was staggered and rolled-out by region to ensure that implementation started at
the same time for all schools but only started in one region at a time. School enrollment was
used as a stratification variable, so that schools assignments to the intervention and
control arm were balanced within stratum. Randomization was performed within each region at
the school level and was stratified into two categories by school size. For the Midwest
region, small was defined as <500 enrollment and large was =>1000. For the Southern region,
small was defined as <700 enrollment and large was =>700.
Active parental consent and student assent were obtained prior to any data collection. The
steps in the consent process are discussed below:
1. Two weeks or more prior to the surveys (as determined by the participating schools),
evaluation staff went to each participating health class and provided an overview of the
study and distributed parent consent forms to all students in the class, requesting that
they take them home to their parents for review and return the signed forms to their
classroom teacher with parents' decisions regarding participation marked on the form. In
the Southern schools, students received a gift card worth $10 for returning parent
consent forms. The Midwestern schools' administration would not allow for the
distribution of any type of incentives; thus, these schools received a class reward for
taking part in the parent consent process and reaching a threshold (e.g., 75% or more of
students return parent consent regardless of whether parents say "yes" or "no"). All
consent forms were translated into languages requested by each district.
2. Evaluation staff returned multiple times (e.g., 2-3) during the collection period as
agreed upon with the classroom teacher to check on the parent consent return rates and
did brief reminders to students.
3. Between evaluation staff visits to the classrooms, teachers were asked to remind
students to return parent consent forms daily over the collection period and provided
additional forms to students who needed them.
4. After two weeks, evaluation staff worked with the schools to make calls to parents using
a scripted protocol to read the consent form over the phone and secure parents'
decisions or send them the form for them to return it by mail with their decision. In
nine schools within one district in the Midwest region, we trained their nursing office
staff (which included Health Educational Assistants and Licensed Practical Nurses) to
make verbal consent calls home to parents at the request of district administration.
These staff members are already responsible for communicating with parents about
health-related matters and given that this was a health-related research study, the
administration felt that these calls would be better received by their staff, rather
than unfamiliar data collectors.
The primary source of data for the outcome analyses is the student self-report survey. The
survey was administered three times over the course of the study. In the Midwest region this
occurred: Fall 2016 (baseline), Spring 2017 (3-month follow-up), and Fall-Winter 2017-2018
(12-month follow-up). In the Southern region, data collection took place: Fall 2017
(baseline), Spring 2018 (3-month follow-up) and Fall-Winter 2018-2019 (12-month follow-up).
Data were collected by trained data collectors in schools using handheld tablets. For
students who left school after baseline but before follow-up surveys could be administered,
we worked to survey these students at their new schools, online, or by mail.
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