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临床试验/NCT02009046
NCT02009046已完成不适用

Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students

Public Health Institute, California2 个研究点 分布在 1 个国家目标入组 1,909 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,909
试验地点
2
主要终点
Percent of Participants With Sexually Transmitted Infection (STI) Risk

研究概览

简要总结

This study examines the effectiveness of the Sexuality Education Initiative (SEI), a comprehensive, multi-component, rights-based sexuality education program developed and implemented by Planned Parenthood Los Angeles for high school students. The primary goal of the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy component, (3) a parent education component, and (4) clinical services linkages. It is hypothesized that the 12-session classroom curriculum is more effective than a 3-session control sex education curriculum. It is also hypothesized that the full SEI package (all four components) is more effective than the control condition (control curriculum and clinical services only).

详细描述

This study examines the effectiveness of the Sexuality Education Initiative (SEI), a comprehensive, multi-component, rights-based sexuality education program developed and implemented by Planned Parenthood Los Angeles for high school students. The primary goal of the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy component, (3) a parent education component, and (4) clinical services linkages.

  • The 12-session gender-sensitive, rights-based classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making.
  • The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as school-wide resources to their peers, organize health events at school, and refer students to school-based clinic services.
  • The parent education component consists of a series of sessions for parents, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use.
  • The in-school clinical services component provides "clinic without walls" health services on campus, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also trains teachers and school staff to distribute condoms to students as needed.

The evaluation design involves two levels of randomization: First, all schools are randomized into one of two conditions: receiving all three SEI school wide components (peer, parent, clinical services) or receiving only one of these three school wide components (clinical services). Schools are randomized within matched pairs of demographically similar schools. Second, within each school, classrooms are randomized into one of two conditions: a basic 3-session sex education curriculum (control) or the 12-session SEI curriculum (intervention). Thus, all participating 9th grade students will receive at least three sexuality education curriculum sessions and access to on-site clinic services.

The primary research questions for the evaluation are:

  1. Is the 12-session SEI gender-sensitive, rights-based sexuality education curriculum more effective than a 3-session comparison curriculum in reducing risk of unwanted pregnancy and sexually transmitted infections (STIs) among high school students?
  2. Is the full comprehensive program (all four components as a package) more effective than the two-component comparison condition (only the 3-session comparison curriculum and the clinical services linkages) in reducing risk of teen pregnancies and STIs?

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
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 9th grade student at a participating high school in East or South Los Angeles
  • Written parent/guardian consent and student assent to participate

排除标准

  • 未提供

研究组 & 干预措施

SEI Classroom Curriculum

Experimental

Participants receive the SEI classroom curriculum.

干预措施: SEI Classroom Curriculum (Behavioral)

Control Classroom Curriculum

Active Comparator

Participants receive the control classroom curriculum.

干预措施: Control Classroom Curriculum (Behavioral)

SEI Curriculum + 3 School Components

Experimental

Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).

干预措施: SEI Curriculum + 3 School Components (Behavioral)

Control Curriculum + 1 School Component

Active Comparator

Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).

干预措施: Control Curriculum + 1 School Component (Behavioral)

结局指标

主要结局

Percent of Participants With Sexually Transmitted Infection (STI) Risk

时间窗: 1 year

Between-arm difference in percent of youth who report engaging in recent vaginal, anal and/or oral sexual intercourse but not using condoms

Percent of Participants Who Ever Used Sexual and Reproductive Health Services

时间窗: 1 year

Between-arm difference in percent of youth who report ever using sexual and reproductive health services

Percent of Participants With Pregnancy Risk

时间窗: 1 year

Between-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms

Percent of Participants With Multiple Sexual Partners

时间窗: 1 year

Between-arm difference in percent of youth who report having more than one recent vaginal, anal and/or oral sexual partner

次要结局

  • Percent of Participants With Recent Oral Sex Activity(1 year)
  • Percent of Participants Who Used Condom at Last Sex(1 year)
  • Percent of Participants Who Ever Had Sex(1 year)
  • Percent of Participants Who Ever Had Oral Sex(1 year)
  • Percent of Participants Who Used Contraceptive at Last Sex(1 year)
  • Percent of Participants With Recent Sexual Activity(1 year)
  • Percent of Participants Who Currently Have Condom(1 year)

研究者

发起方
Public Health Institute, California
申办方类型
Other
责任方
Sponsor

研究点 (2)

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