Study Protocol: a Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention in Chilean Students
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 609
- 主要终点
- Change in knowledge of sexuality
研究概览
简要总结
The goal of this randomized controlled trial (RCT) is to evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on) in adolescents, using a mixed experimental design. The intervention will be directed exclusively to students of the 10th and 11th grades who are enrolled in one of the education establishments that depend on the Municipality of Santiago. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention and a 3-month follow-up).
详细描述
The investigators propose a mixed experimental design with a randomized controlled trial (RCT) that will evaluate the efficiency of an intervention and implementation of a comprehensive gender-transformative sexual education, along with qualitative studies to understand the implementation process. The results of the intervention will be evaluated after it finishes, and in a three-month follow-up. Each participant will be sent a link to the questionnaire (web-based survey). Follow-up contact will be done with WhatsApp or telephone calls.
The hypothesis is that the intervention designed and implemented in the experimental group: (1) will increase their sexuality knowledge level; (2) will increase their preventive sexual behavior (or intentions); (3) will favor a gender-positive attitude; and (4) will decrease internalizing and externalizing problems in mental health. The secondary objective is to examine the implementation intervention process, that is, identify the strengths and obstacles in the real context in which the study intervention is performed, to understand the determinants and strategies of the success of the implementation.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schools with students of the 10th and 11th grades who are enrolled in one of the education establishments that depend on the Municipality of Santiago.
- •Schools not being an education center oriented to adults or persons deprived of liberty (e.g. closed or semi-closed compounds of Gendarmería de Chile or the National Service for Minors)
- •Schools with regularity in teaching and learning (for example, schools that were not partially interrupted in 2022 by student manifestations)
- •Schools with informed consent of the director.
- •Students having 90% or greater attendance in classes
- •Students providing informed consent of voluntary participation
- •Students having explicit and informed consent of their parents or guardians.
排除标准
- •Schools being an education center oriented to adults or persons deprived of liberty
- •Schools without informed consent of the director
- •Students without class attendance
- •Students without informed consent of voluntary participation
- •Students without an explicit and informed consent of their parents or guardians
结局指标
主要结局
Change in knowledge of sexuality
时间窗: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Related to information about the biological components of sexuality. The test used will be the Knowledge Test (KT). This is a 34-item multiple choice instrument which was designed to evaluate the knowledge on sexuality in adolescents; it evaluates areas including pregnancy, STI, physical development. Higher scores represent more favorable attitudes. Its reliability is α=0.89. These assessed areas will be combined to report the level of knowledge.
Change in preventive sexual behavior
时间窗: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Related to behavior in sexuality and preventive behavior in sexuality. Ad-hoc survey. It will be elaborated by the research team to evaluate the behavior and intention, self-efficacy and empowerment in sexuality in LGTB and female-male students. Ad-hoc surveys have been used and reported in other RCT of interventions in sexual health.
Change in gender actitude
时间窗: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Related to positive disposition towards persons of different genders. The test used will be the Scale for Detection of Sexism in adolescents (DSA). This is an instrument of 26 items developed for adolescents. It evaluates sexism, differentiating between hostile and benevolent sexism. The response scale for the items is a Likert type with six alternatives (from 1=disagree completely to 6=agree completely). Higher scores indicate more sexism. Its reliability is α= .881.
Change in components of mental health related to sexual health
时间窗: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Decrease of internalizing symptomology. The test used will be the Pediatric Symptom Checklist (PSC-17). It evaluates general psychosocial functioning, detecting emotional and behavioral difficulties in children and adolescents. Higher scores represent more internalizing behaviors. reliability is α= .72.
次要结局
未报告次要终点
研究者
Loreto Leiva
Associate professor
University of Chile