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临床试验/NCT03533192
NCT03533192已完成不适用

Teenage Pregnancy Prevention: Replication of Evidence-based Programs

The University of Texas Health Science Center, Houston0 个研究点目标入组 2,588 人开始时间: 2012年9月1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
2,588
主要终点
Initiation of vaginal or oral sex

研究概览

简要总结

The purpose of this school-level randomized intervention trial is to evaluate the It's Your Game...Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program, among 2,000 students from 20 middle schools in 10 participating school districts in Harris County and surrounding areas. An audio computer-assisted self interview (A-CASI) assessment was used to assess demographic characteristics, psychosocial factors, sexual behaviors, and program exposure at three data collection points. Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.

详细描述

Program Implemented: It's Your Game...Keep It Real (IYG) consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). The intervention was provided to the same 7th and 8th graders over a two-year period (i.e., the same students receive up to 24 lessons over two years). The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models. The lessons were delivered according to the schedule that worked best for schools (for example, twice a week, once a week, or daily) within a school semester. The lessons were delivered by trained teachers during regular classroom time and were taught during a variety of subject areas (for example, physical education/health, social studies, and science). Teachers implementing the lessons were required to attend training in order to teach the 7th- and 8th-grade lessons.

Sample: This sample included students at 20 schools from selected school districts throughout the greater Houston, Texas, area that agreed to participate in the study and that served 7th and 8th grades. Student inclusion criteria required that students not face language barriers or require educational accommodations that would preclude them from participation in the survey data collection process. Data collection staff, blind to school study condition, recruited 7th-grade students attending eligible classes across the 20 middle schools participating in the randomized controlled trial. A mix of census and sampling was used when securing consent for participation. In schools with 250 or fewer 7th-grade students, consents were distributed to all students. For schools with 7th-grade enrollments of more than 250, classes were sampled randomly and consents were distributed to 180 students. The study included one cohort and followed students from 7th through 9th grades. The final enrolled sample size was 2,588 students for whom parental consent and student assent were obtained.

Setting: The study sites included 20 urban middle schools, in Harris County, Texas. The program was implemented in 10 intervention schools by trained facilitators. Most facilitators in both 7th and 8th grades were physical education teachers.

Data Collection: Data was collected at baseline (preintervention), 6 months post intervention, and 12 months post intervention.

Data Analysis: Impact data were analyzed using multilevel regression due to the nested nature of the study design (students within schools).

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
Single (Outcomes Assessor)

盲法说明

Data collectors were blind to condition.

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • enrolled in 7th grade at a participating school in fall 2012
  • did not have limited capabilities or special needs as determined by the school
  • spoke English well enough to understand the survey questions if they were read aloud.

排除标准

  • did not meet inclusion criteria

研究组 & 干预措施

Receipt of It's Your Game...Keep it Real

Experimental

It's Your Game...Keep it Real is an HIV, STI, and teen pregnancy prevention program

干预措施: It's Your Game...Keep it Real (Behavioral)

Usual care

No Intervention

Students received their regular health education.

结局指标

主要结局

Initiation of vaginal or oral sex

时间窗: 12 months after the program ends

The variable is a yes/no measure of whether a person has ever had vaginal OR oral sex. The measure is created from the following items on the survey: * "Have you ever had sexual intercourse?" (defined in survey as penis in vagina) * "Have you ever had oral sex?" Participants who respond yes they have had sexual intercourse OR yes they have had oral sex are coded as 1 for yes; those who respond no they have not had sexual intercourse AND no they have not had oral sex are coded as 0 for no.

次要结局

  • Participation in vaginal sex without a condom(past 3 months)
  • Participation in vaginal sex without an effective method of birth control(past 3 months)
  • Use of Condom at last sex(past 3 months)
  • Percent of youth who report having vaginal sex 2 or more times in the past 3 months(past 3 months)
  • Percent of youth who report using drugs or alcohol before oral sex at least 1 time in the past 3 months(past 3 months)
  • Beliefs about waiting until marriage to have sex(Past year)
  • Initiation of oral sex(12 months after the program ends)
  • Percent of youth who report having vaginal sex with 2 or more partners in the past 3 months(past 3 months)
  • Initiation of vaginal intercourse(12 months after the program ends)
  • Percent of youth who report having oral sex 2 or more times in the past 3 months(past 3 months)
  • Percent of youth who report using drugs or alcohol before vaginal sex at least 1 time in the past 3 months(past 3 months)
  • Use of effective method of birth control at last sex(past 3 months)
  • Percent of youth who report having oral sex with 2 or more partners in the past 3 months(past 3 months)
  • General condom knowledge(Past year)
  • General HIV/STI knowledge(Past year)
  • Knowledge of signs and symptoms of STIs(Past year)
  • General beliefs about waiting to have sex(Past year)
  • Reasons to not have sex(Past year)
  • General beliefs about condoms(Past year)
  • Perceived norms about sex (I)(Past year)
  • Perceived friends sexual behaviors (I)(Past year)
  • Perceived friends' beliefs about condoms(Past year)
  • Perceived friends beliefs about waiting to have sex(Past year)
  • Perceived friends sexual behaviors (II)(Past year)
  • Personal limits regarding sex(Past year)
  • Personal limits regarding condoms(Past year)
  • Exposure to risky situations(Past 3 months)
  • Intentions to use a condom if have sex in the next year(Past year)
  • Intentions to get tested for HIV/STI if think at risk(Past year)
  • Perceived norms about sex (II)(Past year)
  • Perceived self-efficacy to refrain from having sex(Past year)
  • Perceived self-efficacy to obtain and correctly use condoms(Past year)
  • Intentions to remain abstinent until the end of high school(Past year)
  • Intentions to remain abstinent until marriage(Past year)
  • Perceived self-efficacy to negotiate the use of condoms with a partner(Past year)
  • Intentions to use effective birth control if have sex in the next year(Past year)
  • Communication with parents about sex(Past year)
  • Intentions to have sex in the next year(Past year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Peskin

Associate Professor

The University of Texas Health Science Center, Houston

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