Evaluation of Peer Group Connection - Middle School (PGC-MS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- Initiation of sexual intercourse
研究概览
简要总结
This study is a randomized controlled trial to assess the impact of the Peer Group Connection - Middle School (PGC-MS) intervention on pre-sexual behaviors and sexual initiation in middle school-aged youth. The primary research questions it aims to answer are:
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reported initiation of sexual intercourse at sixteen months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever smoking a cigarette at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using an electronic vapor product at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever having a drink of alcohol at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using marijuana at four months post-intervention?
Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).
Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (6th grade). Participants randomized to the control group will be offered class-as-usual.
详细描述
This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th grade); post-intervention (spring semester of 6th grade); four months post-intervention (fall semester of 7th grade); and sixteen months post-intervention (fall semester of 8th grade).
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
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be enrolled at a middle school participating in the study
- •Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
- •Provide parental consent and student assent to participate in the study
- •Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.
排除标准
- •- Repeating the middle school transition year (6th or 7th grade)
研究组 & 干预措施
Class as usual
Peer Group Connection - Middle School (PGC-MS)
干预措施: Peer Group Connection - Middle School (PGC-MS) (Behavioral)
结局指标
主要结局
Initiation of sexual intercourse
时间窗: Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)
Participants are asked the following item: Have you ever had sexual intercourse?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had sexual intercourse and 1 indicates a person who has had sexual intercourse.
次要结局
未报告次要终点