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

NCT05896540 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2023-06-09

No results posted yet for this study

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).

Conditions

  • Sexuality

Interventions

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.

Sponsors & Collaborators

  • National Fund for Research and Development in Health, Chile

    collaborator OTHER

  • University of Chile

    lead OTHER

Principal Investigators

  • Loreto Leiva, PhD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-05
Primary Completion
2023-09-03
Completion
2023-12-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896540 on ClinicalTrials.gov