El Camino: Tier 2 Rigorous Evaluation of Promising Interventions in Promotion of Healthy Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Child Trends
- 入组人数
- 746
- 试验地点
- 4
- 主要终点
- Had penis-in-vagina sex in the last three months
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the impacts of El Camino, a goal-setting sexual health promotion program targeted toward Latino adolescents. The primary research questions are:
- Research Question 1: Is participation in the El Camino goal setting program associated with greater abstinence (measured as never had sex, no recent sexual activity) relative to a comparison group that did not receive El Camino?
- Research Question 2: Is participation in El Camino associated with reduced unprotected sex (measured as sex without any method of contraception, sex without a condom) for the intervention group relative to the comparison group?
Researchers will compare those who received El Camino to a comparison group who received an alternative program that does not include sexual health components.
As part of the study, participants will be asked to:
- Attend approximately 11 hours of programming completed over 11 weeks
- Complete baseline, post-intervention, and 12-month follow-up surveys
- For select participants who received the El Camino program, participate in an optional focus group discussion
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
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High school student in Montgomery County, MD
- •Have not previously received El Camino during pilot study
- •Have parental consent (if under 18)
- •Agree to be in study
排除标准
- •Previously participated in pilot study and received El Camino curriculum
- •No parental consent (if under 18)
- •Do not agree to be in study
结局指标
主要结局
Had penis-in-vagina sex in the last three months
时间窗: Immediately following program completion, 12 months after program completion
Had penile-vaginal sex in the past three months, even once (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise
Ever had penis-in-vagina sex
时间窗: Immediately following program completion, 12 months after program completion
Ever had penis-in-vagina sex (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise
Had penis-in-vagina sex in the last three months without any method of contraception
时间窗: Immediately following program completion, 12 months after program completion
Survey measure: "In the past 3 months, how often have you or your partner used any method of birth control, including condoms, during penis-in-vagina sex?" 5 response categories: 4-point scale from "All of the time" (4) to "None of the time" (1) and I don't know. Coded as 0 if answer is "All of the time". Otherwise coded as 1
Had penis-in-vagina sex in the last three months without use of a condom
时间窗: Immediately following program completion, 12 months after program completion
Survey measure: "In the past 3 months, how often have you or your partner used condoms during penis-in-vagina sex?" 5 response categories: 4-point scale from "All of the time" (4) to "None of the time" (1) and I don't know. Coded as 0 if answer is "All of the time". Otherwise coded 1
次要结局
- Attitudes about birth control(Immediately following program completion, 12 months after program completion)
- Intend to use contraception(Immediately following program completion, 12 months after program completion)
- Decreased psychological distress(Immediately following program completion, 12 months after program completion)
- Intend to use condoms(Immediately following program completion, 12 months after program completion)
- Attitudes about condoms(Immediately following program completion, 12 months after program completion)
- Awareness of birth control methods(Immediately following program completion, 12 months after program completion)
- Knowledge about birth control(Immediately following program completion, 12 months after program completion)
- Confidence going to a clinic to get contraception(Immediately following program completion, 12 months after program completion)
- Knowledge about condoms(Immediately following program completion, 12 months after program completion)
- Knowledge about consent(Immediately following program completion, 12 months after program completion)
- Definitely know where to get birth control(Immediately following program completion, 12 months after program completion)
- Confidence discussing sex, contraception(Immediately following program completion, 12 months after program completion)
- Confidence limit setting(Immediately following program completion, 12 months after program completion)
- Confidence stating and asking for consent(Immediately following program completion, 12 months after program completion)
- Increased educational goal setting(Immediately following program completion, 12 months after program completion)
研究者
Jennifer Manlove
Senior Research Scholar
Child Trends