Louisville Teen Pregnancy Prevention Project (CHAMPS)
2017年4月20日 更新者：Anita Barbee、University of Louisville
Creating Healthy Adolescents Through Meaningful Prevention Services
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
1450
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kentucky
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Louisville、Kentucky、美国、40203
- Department for Community Based Services: Jefferson County Region
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Louisville、Kentucky、美国、40203
- House of Ruth
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Louisville、Kentucky、美国、40203
- Presbyterian Community Center
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Louisville、Kentucky、美国、40205
- Jewish Family and Career Services
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Louisville、Kentucky、美国、40207
- Gate of Hope Ministries
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Louisville、Kentucky、美国、40210
- St George Community Center
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Louisville、Kentucky、美国、40212
- Neighborhood House
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Louisville、Kentucky、美国、40212
- One Plus One Equals You
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Louisville、Kentucky、美国、40214
- Americana Community Center
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Louisville、Kentucky、美国、40218
- Canaan Community Development Corporation
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Louisville、Kentucky、美国、40223
- Maryhurst
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Louisville、Kentucky、美国、40259
- The Steward's Staff
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 至 19年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age 13 or younger, 20 or older;
- Married
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Reducing the Risk
Students will be randomly assigned to participate in Reducing the Risk training
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Reducing the Risk: Building Skills to Prevent Pregnancy, STD and HIV (RtR) was developed by Richard Barth, MSW, Ph.D. in California.
The training manual is in its 5th Edition and was last published in 2011.
This curriculum is one of the first that was evaluated using an experimental design, with a longitudinal follow up (6 months and 18 months) and tested on a large group of high school students (N = 758).
It is also one of the first programs to show an impact on beliefs of adolescent sexual behavior prevalence and actual behavior as well as increasing parent-child communication about abstinence and contraception (Kirby, Barth, Leland, and Fetro, 1991).
其他名称：
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实验性的：Love Notes
The second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009).
Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, & Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov).
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The second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009).
Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, & Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov).
This curriculum builds on social exchange theory and meets the needs of youth who are alienated and in need of loving personal relationships.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pregnancy
大体时间：2 years
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Number of girls that get pregnant.
Number of girls and times boys impregnate someone.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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number and type of STIs contracted
大体时间：2 years
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Number of sexually transmitted infections participants contract
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anita P Barbee, Ph.D.、Kent School of Social Work University of Louisville
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年9月1日
初级完成 (实际的)
2014年3月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2011年8月4日
首先提交符合 QC 标准的
2011年8月5日
首次发布 (估计)
2011年8月8日
研究记录更新
最后更新发布 (实际的)
2017年4月24日
上次提交的符合 QC 标准的更新
2017年4月20日
最后验证
2017年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.