跳至主要内容
临床试验/NCT02514759
NCT02514759已完成不适用

The Women's Clinic of Kansas City Teen Outreach Program Replication Study

Philliber Research & Evaluation0 个研究点目标入组 1,885 人开始时间: 2012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
1,885
主要终点
Sexual activity

研究概览

简要总结

The Women's Clinic of Kansas City (TWC) replicated the Teen Outreach Program (TOP) across Kansas City, Missouri. The purpose of this study is to measure: one year after the end of the program year, what is TOP's impact on the treatment group's sexual activity and contraceptive use, relative to the control group, at one year following the program?

详细描述

TOP is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP program model consists of three components implemented in school, after school, or in community settings over nine months: (1) weekly curriculum sessions, (2) community service learning, and (3) positive adult guidance and support. The TOP Changing Scenes Curriculum is separated into four age-/stage-appropriate levels, Level 1 is typically for youth ages 12 or 13 and Level 4 is typically for youth age 17. The curriculum focuses on the presence of a consistent, caring adult; a supportive peer group; skill development; sexual health; and sexual behavior choices. The intended program dosage for each participant is a minimum of 25 weekly sessions (one per week at 40-50 minutes each) and at least 20 hours of community service learning over nine months. One or two facilitators, who plan the order of sessions based on the needs and interest of youth, implemented TOP in a group of 10 to 25 youth.

In this cluster randomized controlled trial, twelve of the highest-risk (based on highest teen births per zip code ranking in 2008) middle and high schools in the Kansas City Metropolitan Area were recruited to participate in the evaluation. After finalizing agreements with seven schools that agreed to participate, 7th- and 9th-grade teachers of core subjects (such as social studies and English) were recruited to participate. During the two years of sample enrollment, 21 teachers participated. At the start of each school year of sample enrollment, the study team assessed whether each participating teacher's class sections would be eligible for the evaluation based on the number of students enrolled (class sections were eligible if they had at least 10 students). Classes were

This study is a cluster randomized controlled trial across two cohorts. Stratification occurred at the teacher level; each teacher's classes were randomized to either TOP or the control condition. Random assignment occurred after acquiring parental consent and youth assent and administering the baseline survey. A passive consent process was used to notify parents that their youth would be participating in a youth development survey unless they opted out of the process. In addition, youth were given the option to not assent to any specific survey. Overall, youth in completed three surveys: (1) baseline, (2) 9-month post-baseline (immediate follow-up), and (3) 21-month post-baseline (1-year post-intervention follow-up). Students were surveyed in class using paper-and-pencil surveys; make-up surveys occurred during follow-up visits to the school over the final few weeks of school. Those chronically absent or no longer enrolled in the study schools were contacted via telephone to complete a telephone survey or via email to complete the survey online. Final efforts were made to visit youth who dropped out or who had been otherwise unreachable by going directly to their homes (if they still lived in the area); these youth were given a paper-and-pencil survey to complete. Students received a modest incentive for completing each survey.

研究设计

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

入排标准

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

入选标准

  • Has parental consent and student assent
  • Attends one of the schools and/or classes chosen for the program

排除标准

  • Lack of consent or assent

结局指标

主要结局

Sexual activity

时间窗: One year after the program (21 months)

TOP's impact on the treatment group's sexual activity, relative to the control group, as measured by the questions "have you ever had sex" and "have you had sexual intercourse in the past three months".

Contraceptive use

时间窗: One year after the program (21 months)

TOP's impact on the treatment group's contraception use, relative to the control group, as measured by the question "have you had sexual intercourse in the past three months without using any method of birth control" and "have you had sexual intercourse in the past three months without using a condom".

次要结局

  • Grades(One year after the program (21 months))
  • School suspensions(One year after the program (21 months))

研究者

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

相似试验