Rigorous Evaluation of the Wrap It Up Intervention's Impact on Pregnancy Prevention Among Rural California Adolescents
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,120
- 试验地点
- 1
- 主要终点
- No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days
研究概览
简要总结
Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. Wrap It Up (WIU) is a sexual health education "booster" program for older high school students attending school in rural communities that was designed to help address this situation. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated with a randomized controlled trial.
WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE.
The study's primary research question is:
What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?
The study's secondary research questions are:
- What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers, peers, and partners about their sexual health?
- What is the impact at 6-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services?
- What is the impact at 12-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?
详细描述
Background Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. Wrap It Up (WIU) is a sexual health education (SHE) "booster" program for older high school students attending school in rural communities that was designed to help address this issue. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated. With this study, ETR will rigorously evaluate the effectiveness of WIU with a randomized controlled trial.
WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections (STIs). This program was created by Health Connected, a non-profit organization with over 30 years' experience in creating, evaluating, training on, and disseminating comprehensive sexual health education to young people and their families throughout California. Health Connected is ETR's implementation partner in this study.
Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE. The WIU program will be administered to groups in school settings, such as science classes or student advisory sessions. We will use trained sexuality education professionals supported by Health Connected to deliver the intervention.
Research Questions
The principal purpose of WIU is to decrease behaviors that contribute to unintended pregnancy and STIs in students and increase behaviors that support prevention and wellbeing. The study's primary research question is:
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
- 16 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Since the study is a cluster RCT, we will identify partner schools before determining eligibility at the individual student level. Each school will participate for 2 years and be randomly assigned to an "intervention first" or "control first" arm. Schools will select a class or other group comprising mostly or solely 11th and 12th graders (e.g., a science class, the 11th grade annual retreat) for us to carry out the study with, and commit to providing a similar class or group for participation in their second year of the study.
- •Inclusion Criteria:
- •part of the class or group identified by their school
- •16 to 19 years old
- •sufficient English language skills (as assessed by data collector) to take part in the TTHSR intervention
排除标准
- •Under 16 years old
- •20 years old or over
- •Insufficient English language skills (as assessed by data collector) to take part in the Wrap It Up intervention
研究组 & 干预措施
WIU Intervention
Intervention: Students in schools in this group will receive Wrap It Up, a 4-to-5-session SHE "booster" program
干预措施: Wrap It Up (WIU) (Behavioral)
Comparison
"Business-as-usual" control: Students in schools in this group will receive their school's normal classroom teaching
结局指标
主要结局
No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days
时间窗: 6 months post-baseline
Vaginal sex: Single-item dichotomous measure assessing any consensual vaginal sex in the past 3 months. If yes, condom and birth control use measured with single-item categorical frequency of (a) condom use with consensual vaginal sex in past 3 months and (b) birth control use, other than condoms, with consensual vaginal sex in past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never. Anal sex: Single-item dichotomous measure assessing any consensual anal sex in the past 3 months. If yes, condom use measured with single-item categorical frequency of condom use with consensual anal sex in the past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never.
次要结局
- Improved self-efficacy for self-advocating with healthcare providers, peers, and partners about sexual health(6 months post-baseline)
- Improved self-efficacy to find and access sexual health services(6 months post-baseline)
- No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days(12 months post-baseline)