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临床试验/NCT04508569
NCT04508569已完成不适用

Evaluation of the Big Decisions Teen Pregnancy Prevention Intervention in Three South Texas School Districts

Philliber Research & Evaluation2 个研究点 分布在 1 个国家目标入组 3,170 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,170
试验地点
2
主要终点
Use of condom or effective method of birth control last time you had sex

研究概览

简要总结

An evaluation of a promising Teen Pregnancy Prevention Curriculum, Big Decisions, in ninth grade students in three high schools in South Texas.

详细描述

Intervention Description Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.

Classroom teachers, who receive three days of training on the curriculum as well as ongoing technical assistance, deliver Big Decisions lessons to 9th grade students. The lessons take place during normally scheduled classes over the course of three to five weeks. Classes include health, biology, and English. The curriculum focuses on helping youth make good decisions about their sexual health. There are three key messages: (1) having sex with someone is a big decision, (2) abstinence is the most effective way to avoid both pregnancy and sexually transmitted infections, and (3) teens who have sex need to use latex condoms correctly every time to reduce the risk of HIV and sexually transmitted infections and use contraception to prevent pregnancy.

In addition to a classroom curriculum, Big Decisions also includes a parent component offered to all families. This includes two parent workshops, a parent workbook, and homework for parents and children. The parent workshop meets twice during the period of time when students receive the classroom curriculum. The workshops last for 90 minutes, are offered in both English and Spanish, and are facilitated by district coordinators and grantee staff.

Comparison Condition Youth Voices Comparison Condition Description Youth Voices is a benign comparison intervention that meets for two class sessions over three to five weeks. Classroom teachers deliver Youth Voices to 9th grade students. Teachers deliver sessions during regularly scheduled classes similar to Big Decisions. Students in Youth Voices participate in facilitated discussions about two of seven potential discussion topics (nutrition, physical fitness and exercise, tobacco and e-cigarettes, participation in sports, driver safety, environmental health, and safety at work). Students take a vote, and they discuss the two topics with the most votes during the sessions. Classroom teachers facilitate Youth Voices. Teachers are trained to deliver both Youth Voices and Big Decisions and can deliver both programs to different classes during the same implementation period.

Behavioral Outcomes Sexual initiation, condom use at last sex, birth control use at last sex, ever pregnant or gotten someone pregnant, sex in the past three months, sex without a condom in the past three months, sex without birth control in the past three months Non-behavioral Outcomes Intentions to have sex, intentions to use a condom, intentions to use birth control Sample and Setting HealthyFutures of Texas staff recruited four high schools from three rural and semi-rural school districts in Texas for participation in the study. The program targets 9th-grade students in each district for participation. Each high school identified one course required for 9th grade students for program delivery (for example, health, biology, English). To be eligible for participation, students must (1) be in 9th grade, (2) be enrolled in one of the courses identified for program delivery, (3) have parental consent, and (4) provide student assent. The evaluation expects to enroll 2,596 students from 178 classrooms.

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Must be in ninth grade and enrolled in a participating class at a participating high school

排除标准

  • Lack of consent or assent

结局指标

主要结局

Use of condom or effective method of birth control last time you had sex

时间窗: One year

Did you use a condom or effective method of birth control the last time you had sex?

次要结局

  • intention to use condom or birth control(immediate post-test)
  • Frequency of communication with parents about abstinence and sex(immediate post-test)

研究者

发起方
Philliber Research & Evaluation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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