Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention (ENFOCATE)

Study Protocol: a Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention in Chilean Students

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Sexuality
• Intervention / Treatment: Behavioral: ENFOCATE

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.

• Study Type: Interventional
• Enrollment (Estimated): 609
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loreto Leiva, PhD; Phone Number: +56 9 99498032; Email: loretoleivab@u.uchile.cl
• Study Contact Backup: Name: Betzabe Torres, MSc; Phone Number: +56 9 66376880; Email: betzabe.torres@ug.uchile.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STUDY GROUP 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.	Behavioral: ENFOCATE; ENFOCATE is a comprehensive program of sexual education for adolescents. Its design follows the guidelines of the Intervention Mapping Approach and the orientations proposed by the Framework for Gender-Transformative Health Promotion. The intervention has a participative focus, thus the activities are designed to promote processes of knowledge, understanding, application and reflection in the adolescents. The activities aim to improve the capacity for critical thinking, increase the motivation to listen and learn actively, and to improve interpersonal abilities. The execution of the intervention uses three pillars: (i) preventive sexual behavior; (ii) gender equity; and (iii) mental health. The intervention consists of ten weekly sessions, each lasting one hour. The teams that will perform the intervention will be composed of at least two professionals of the psychosocial area (mainly psychologists, social workers and/or guidance counsellors) of the schools included in the study.
No Intervention: CONTROL GROUP; The control groups will not receive intervention; they will continue with the sexual orientation that each school provides to its students.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge of sexuality	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.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Change in preventive sexual behavior	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.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Change in gender actitude	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.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Change in gender actitude	Related to positive disposition towards persons of different sexual orientation. The test used will be the Scale of negative attitudes toward trans persons (NATP). It measures attitude as an expression of prejudice towards trans persons. It has nine items with a Likert scale with five response options, from 1= disagree completely to 5=agree completely. Higher scores are indicators of higher levels of negative attitudes toward persons of different sexual orientation. Its reliability is α= .886.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Change in gender actitude	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.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Change in components of mental health related to sexual health	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.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Change in components of mental health related to sexual health	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.	One-week pre-intervention, immediately post-intervention and a 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: National Fund for Research and Development in Health, Chile
• Investigators: Principal Investigator: Loreto Leiva, PhD, University of Chile

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2023
• Primary Completion (Estimated): September 3, 2023
• Study Completion (Estimated): December 29, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: School intervention; School-based sexual health intervention; Gender perspective
• Other Study ID Numbers: FONIS SA21I0142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No