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临床试验/NCT04079608
NCT04079608已完成不适用

Rigorous Evaluation of High School FLASH

ETR Associates1 个研究点 分布在 1 个国家目标入组 1,597 人开始时间: 2016年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,597
试验地点
1
主要终点
Self-reported rates of vaginal sex

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •was determined at three levels:
  • •District level eligibility: Districts must have been from regions with teen birth rates at or above the national average at the time of study recruitment. They also much have agreed with randomization of mainstream schools to either High School FLASH or the five-session knowledge-based comparison condition. We worked with 7 different districts in two different regions of the U.S. - the Midwest (2 districts) and the South (5 districts).
  • •School level eligibility: Schools were eligible to participate if they: (1) agreed with inviting all students in targeted grade level in the fall semester required class to take part in the study (9th or 10th grades depending on health education course placement); (2) had a policy environment that enabled implementation of all FLASH components if randomized to intervention condition; (3) were in a district not currently mandating comprehensive sexuality education or using an evidence-based sexual health curriculum in school or for after-school programs; and (4) have schools large enough to ideally contribute 40 or more students to the study.
  • •Student level eligibility: Student enrollment into the study must have included (1) being in targeted classes during the enrollment window (fall semester 2016 in the Midwest and fall semester 2017 in the South), (2) providing positive parent consent to take part in study survey; and (3) providing assent to take part in the survey.

排除标准

  • •Anyone not meeting inclusion criteria

研究组 & 干预措施

FLASH curriculum

Experimental

Students who will receive the FLASH high school curriculum.

干预措施: FLASH curriculum (Behavioral)

Sexual Health Education for Adolescents

Active Comparator

Students will receive a five-session knowledge-based sexual health curriculum designed for classroom settings.

干预措施: Sexual Health Education for Adolescents (Behavioral)

结局指标

主要结局

Self-reported rates of vaginal sex

时间窗: 12 months post-intervention

Measured with a single item required and provided by the funder: "In the past 3 months, have you had vaginal intercourse, even once?" Yes/No

Self-reported rates of vaginal sex without a condom or other birth control

时间窗: 12 months post-intervention

Combined the following two questions required and provided by the funder: "In the past 3 months, have you had vaginal intercourse without you or your partner using a condom?" and "In the past 3 months, how many times have you had vaginal intercourse without you or your partner using any of these methods of birth control: birth control pills, the shot, the patch, the ring, intrauterine device (IUD), or Implant" New outcome was coded 'yes' if either question was endorsed and 'no' if both questions were responded to as 'no'

Self-reported rates of vaginal sex

时间窗: 3 months post-intervention

Measured with a single item required and provided by the funder: "In the past 3 months, have you had vaginal intercourse, even once?" Yes/No

Self-reported rates of vaginal sex without a condom or other birth control

时间窗: 3 months post-intervention

Combined the following two questions required and provided by the funder: "In the past 3 months, have you had vaginal intercourse without you or your partner using a condom?" and "In the past 3 months, how many times have you had vaginal intercourse without you or your partner using any of these methods of birth control: birth control pills, the shot, the patch, the ring, intrauterine device (IUD), or Implant" New outcome was coded 'yes' if either question was endorsed and 'no' if both questions were responded to as 'no'

次要结局

  • Self-reported initiation of vaginal sex(12 months post-intervention)
  • Self-reported knowledge of sexually transmitted disease (STD) testing(12 months post-intervention)
  • Self-reported comfort with family communication regarding sexual health(12 months post-intervention)
  • Self-reported initiation of vaginal sex(3 months post-intervention)
  • Self-reported knowledge of sexually transmitted disease (STD) testing(3 months post-intervention)
  • Self-reported comfort with family communication regarding sexual health(3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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