Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention
- Conditions
- Sexuality
- Interventions
- Behavioral: ENFOCATE
- Registration Number
- NCT05896540
- Lead Sponsor
- University of Chile
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 609
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STUDY GROUP ENFOCATE ENFOCATE The selected students will be randomly divided into the study and control groups; the intervention will take place in the same schools that the students attend. The assignment to groups will use simple random sampling, performed in two stages. In the first stage the available schools will be randomly assigned to the study and control groups, while the second stage will select randomly the groups in each school that will participate in the study. The study groups will receive a 10-session intervention in sexual education, covering topics related to preventive sexual conduct, gender equity and mental health.
- Primary Outcome Measures
Name Time Method Change in preventive sexual behavior 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 knowledge of sexuality 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 gender actitude One-week pre-intervention, immediately post-intervention and a 3-month follow-up Related to positive disposition towards persons of different sexual orientation. The test used will be the Short version of Modern Homophobia Scale (MHS). It measures homophobic attitudes in the dimension personal discomfort, institutional and deviation/changeability. It is composed of 46 items that evaluate attitudes towards lesbians and gay in a Likert scale of 1-5 in which higher scores interpret more positive attitudes towards homosexuality and lesbianism. Its reliability is α= .80.
Change in components of mental health related to sexual health One-week pre-intervention, immediately post-intervention and a 3-month follow-up Decrease of externalizing 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 externalizing behaviors. Its reliability is α= .72.
- Secondary Outcome Measures
Name Time Method