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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-05

Study Completion Date

2023-12-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of a Socio-educational Intervention on Sexual Health in Young University Students

NCT04429672

Sexual Health

UNKNOWN NA

Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents

NCT03669913

Relationship Problems Specific to Childhood and Adolescence

UNKNOWN NA

Internet-based Intervention to Prevent Risky Sexual Behaviors in Mexican Adolescents

NCT02686736

Adolescent Behavior

COMPLETED NA

Transgender Health: an Educational RCT

NCT05080335

Transgender Health Attitude

COMPLETED NA

Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts

NCT05830643

Paraphilias and Paraphilic Disorders

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexuality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The assignment of the participants to the groups will be implemented in a two-stage selection of the students; since there are already existing teaching-learning processes in process in the schools, with their time limitations, the investigators will have to choose entire "courses" (in Chilean secondary schools, a course is a group of about 40 students who have all classes together) rather than choose individual students. The investigators will establish groups among the schools to compensate for their different sizes; some schools in the commune are much larger than the others (four or more courses per grade. Thus the investigators will divide the schools into two blocks; one with the largest schools and one with the medium- and small-sized schools. In the second stage, courses that meet the inclusion criteria to participate in the study will be selected randomly within each of the blocks. Table 1 details the distribution of the samples.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ENFOCATE

Intervention Type BEHAVIORAL

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.

CONTROL GROUP

The control groups will not receive intervention; they will continue with the sexual orientation that each school provides to its students.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes