SexualityENFOCATENCT05896540
Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention
A study testing ENFOCATE in people with Sexuality, run by University of Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexuality
- What is being tested?
- ENFOCATE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- Sexuality
- Being tested
- ENFOCATE
- Keywords
- School-based sexual health intervention, Gender perspective, School intervention
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENFOCATEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP ENFOCATE | Experimental | 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. Receives: Behavioral: ENFOCATE |
| CONTROL GROUP | No intervention | The control groups will not receive intervention; they will continue with the sexual orientation that each school provides to its students. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start5 Aug 2023 (estimated)
- Primary completion3 Sep 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 609 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Responsible party
- Principal investigator, Loreto Leiva, University of Chile
- Investigators
- Loreto Leiva, PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896540
- Sponsor's protocol ID
- FONIS SA21I0142
- Acronym
- ENFOCATE
- Status last verified
- Jun 2023
- First submitted
- 30 Jan 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leiva L, Torres-Cortes B, Antivilo-Bruna A, Zavala-Villalon G. Gender-transformative school-based sexual health intervention: study protocol for a randomized controlled trial. Trials. 2024 Jun 5;25(1):360. doi: 10.1186/s13063-024-08191-w.
PubMed 38835035
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol: a Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention in Chilean Students
- ClinicalTrials.gov ID
- NCT05896540
- Acronym / sponsor ID
- ENFOCATE / FONIS SA21I0142
- Conditions
- Sexuality
- Keywords
- School-based sexual health intervention, Gender perspective, School intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 609 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Study start
- 5 Aug 2023 (estimated)
- Primary completion
- 3 Sep 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP ENFOCATE | Experimental | Behavioral: ENFOCATEThe 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. |
| CONTROL GROUP | No intervention | –The control groups will not receive intervention; they will continue with the sexual orientation that each school provides to its students. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENFOCATEENFOCATE 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. | Behavioural | STUDY GROUP ENFOCATE |
Primary outcome
Change in knowledge of sexuality
Time frame: 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
Time frame: 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
Time frame: 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 gender actitude
Time frame: 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 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.
Change in gender actitude
Time frame: 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
Time frame: 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.
Change in components of mental health related to sexual health
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Derived from this study: PubMed 38835035Leiva L, Torres-Cortes B, Antivilo-Bruna A, Zavala-Villalon G. Gender-transformative school-based sexual health intervention: study protocol for a randomized controlled trial. Trials. 2024 Jun 5;25(1):360. doi: 10.1186/s13063-024-08191-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreto Leiva, PhD principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
A study testing ENFOCATE in people with Sexuality, run by University of Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loreto Leiva, PhD (+56 9 99498032, loretoleivab@u.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge of sexuality (time frame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.