跳至主要内容
临床试验/NCT01411878
NCT01411878已完成不适用

Creating Healthy Adolescents Through Meaningful Prevention Services

University of Louisville24 个研究点 分布在 1 个国家目标入组 1,450 人开始时间: 2011年9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
1,450
试验地点
24
主要终点
Pregnancy

研究概览

简要总结

This study is comparing the impact of two teen pregnancy prevention interventions, Reducing the Risk and Love Note with a non-related training on community building to determine which is most effective for which participants in delaying sexual initiation, enhancing use of condoms and other forms of birth control, decreasing sexually transmitted diseases and decreasing the number of pregnancies. The participants were 1450 youth between the ages of 14 and 19 including those from poor urban settings, those from immigrant and refugee families and those from the foster care system. Both girls and boys were be in the study. The investigators predict that girls, immigrants and refugees and foster youth will have better outcomes when participating in Love Notes, a program focused on healthy relationship formation and maintenance as a frame for how to manage the sexual aspect of relationships while boys and urban youth will have better outcomes when participating in Reducing the Risk. Both groups will have better outcomes than those in the control condition.

详细描述

The purpose of this research is to conduct a randomized controlled trial with three groups to test the effectiveness of various interventions aimed at reducing risky behavior by teenagers. Two intervention groups will each receive a training intervention to reduce the chances of teen pregnancy, contraction of STIs, and abusive relationships among high risk youth in the Louisville community. The wait-list control group will receive training on the unrelated topic of community building at the same time. According to the Centers for Disease Control (CDC) Youth Risk Behavior Surveillance System (YRBSS), 50% of Kentucky high school students have participated in sexual intercourse, 37% report currently being sexually active, and 14% have reported having sexual intercourse with four or more sexual partners. Furthermore, only 41% of sexually active students reported using a condom the last time they had sex. These are risky sexual practices that may lead to HIV/STI infection, as well as unintended pregnancy, within the adolescent population. Understanding the pregnancy intentions of these adolescents is not only important with regards to adolescent pregnancy, but it is also important in light of HIV and STI infection when 6% of adolescents and young adults (<20 years of age) in Kentucky have been reported as HIV positive since 2009. As of January 2009, Kentucky ranked 42nd for teenage births (where 1 is best) with a teenage birth rate of 56 per 1,000 girls ages 15-19 years of age. Kentucky was only slightly above Mississippi, which ranked 50th with a teenage birth rate of 68.4 per 1,000. Kentucky's teenage birth rate is higher than the national rate which is currently 41.9 per 1,000 girls ages 15-19 years of age. The most recent Kentucky teen birth rates in 2007 show that Jefferson County (52.34 per 1,000 ages 15-19) exceeds the birth rate of the nation. To address these issues, 1450 Louisville youth were given the opportunity to participate in one of two intervention curricula: called Reducing the Risk and Love Notes, or a waiting list control condition.

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 (Participant)

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Parental Informed Consent for enrollment in the CHAMPS! CAMP and accompanying research sessions,
  • Personal assent for participation in the workshop and research sessions.
  • Age 14 to 19 years old ;
  • Affiliation with youth serving organizations, or part of a current foster youth or former foster youth alumni group.

排除标准

  • Age 13 or younger, 20 or older;
  • Inability to participate verbally in English;
  • Cognitive impairment that precludes the subject from giving assent or informed consent for any reason;
  • Refusal of consent to participate in the study by their parent.
  • Already pregnant or a parent, because we are attempting primary prevention.
  • Prior participation in a comparable local program, such as Love U2.

结局指标

主要结局

Pregnancy

时间窗: 2 years

Number of girls that get pregnant. Number of girls and times boys impregnate someone.

次要结局

  • number and type of STIs contracted(2 years)

研究者

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

Anita Barbee

Professor

University of Louisville

研究点 (24)

Loading locations...

相似试验

Louisville Teen Pregnancy Prevention Project | 临床试验