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临床试验/NCT02554825
NCT02554825已完成不适用

Healthy Futures Longitudinal School-Cluster Randomized Controlled Trial

JSI Research & Training Institute, Inc.2 个研究点 分布在 1 个国家目标入组 1,344 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,344
试验地点
2
主要终点
Prevalence of participants who reported vaginal sex

研究概览

简要总结

This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities.

详细描述

This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities. This longitudinal school-cluster randomized controlled trial included 15 public middle schools (n=1,344). Participants were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2). Outcome data sources included five student surveys: baseline; 6th, 7th, 8th grade follow-ups; and 9th grade follow-up (Cohort 1 only).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Students attended one of the 15 participating public middle schools
  • Students were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2)
  • Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study

排除标准

  • Students were were not in the 6th grade at the time of consent
  • Students were not in the school after the consent/assent process occurred
  • Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.

结局指标

主要结局

Prevalence of participants who reported vaginal sex

时间窗: 2 Years

Participants were followed for the duration of the three-year Healthy Futures program delivered in 6th, 7th, and 8th grades. The primary outcome was measured approximately two years (8th grade) after the baseline (6th grade) questionnaire. Prevalence of participants who reported vaginal sex was measured by participant response \[Yes/No\] to the question: "For the purposes of this survey, by sex, we mean a male putting his penis into a female's vagina. Other ways of saying sex are "doing it" or going all the way". Have you ever had sex?"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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