An interventional study of Es tu juego: decide bien (IYG) in Sexual Behavior, Sexually Transmitted Disease (STD) and Condom Use, sponsored by University of Seville. Not yet recruiting at 1 site in Spain. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by University of Seville · Not applicable, Interventional, and Prevention
The investigators are writing to inform participants about a study being carried out by a research group from the University of Granada and the University of Seville, in which the participant's son/daughter is invited to participate. The study has been approved by the Provincial Research Ethics Committee of Granada under code 202499906944441.
The sole intention of the investigators is to ensure that participants receive correct and sufficient information to assess and decide whether or not to give consent for the child's participation in this study. The information sheet should be read carefully, and any questions may be addressed to the investigators.
The objective of the study is to culturally adapt the program It's Your Game: Keep it Real (IYG), which aims to prevent risky sexual and affective behaviors in adolescents. The IYG program consists of 12 lessons, each lasting 45 minutes. These lessons aim to help the child identify personal norms and boundaries regarding sexuality, recognize situations that might challenge these boundaries, and develop refusal skills to maintain them. The program also covers topics such as the characteristics of healthy and unhealthy relationships, friendships, anatomy and reproduction, the social, emotional, and physical consequences of sexual activity, the consequences of teenage pregnancy and STIs, condom and contraceptive use, and communication skills.
This adaptation will involve the child completing all 12 lessons (two lessons per week over a period of six weeks) that make up the IYG program, as well as filling out a series of questionnaires. These questionnaires will allow the investigators to assess the usability of the program in Spain (including ease of use, comprehension, acceptability, as well as aspects most liked and suggestions for improvement).
Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.
In all cases, the CONFIDENTIALITY of the data collected will be maintained in accordance with the European Union General Data Protection Regulation (GDPR) 2016/679 and the Spanish Organic Law on the Protection of Personal Data and Guarantee of Digital Rights (LOPD-GDD) 3/2018, of December 5.
Regarding the study results, these may be shared with the scientific community through presentations, conferences, and/or publications.
The investigators express appreciation in advance for cooperation in this study.
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 264 across 179 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention group will receive the culturally adapted version of It's Your Game (IYG) educational program, which is designed to promote healthy sexual behaviors and prevent risks among adolescents.
Behavioral: Es tu juego: decide bien (IYG)
The control group will participate in the standard sexuality and emotional education training, corresponding to the regular curriculum implemented in the educational setting. The participants in the control group will remain on a waiting list to receive the intervention, which will be implemented once the project has been completed.
Affective-sexual education for adolescents through an gamified online and school-based program.
Proportion of participants maintaining abstinence from oral, vaginal, and anal sex, assessed using a self-administered questionnaire adapted from It's Your Game: Keep It Real.
The primary outcome will be assessed only in participants who have not initiated sexual activity at baseline. Three self-report items will be used to determine whether, since the initial assessment, the participant has initiated: Oral sex, Vaginal sex, Anal sex. Each question will have a dichotomous categorical response (Yes / No). The outcome will be calculated as the number and percentage of participants who respond "No" for each type of sexual activity at the end of follow-up. Data will be presented separately by study group (intervention and control) and by type of sexual activity. Measurement Details: Instrument: Structured self-administered questionnaire, culturally adapted and validated in Spanish adolescent populations during the pilot phase. Response format: Yes / No. Interpretation: A higher proportion of "No" responses indicates a better outcome (greater delay in the initiation of sexual activity). Data aggregation method: Calculation of percentages and absolute and r
Time frame: Baseline (Month 0), at the end of the first and second school year of implementation and the end of the following school year and end of follow-up (Month 24)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The project will generate qualitative data (focus groups with adolescents, parents, associations, public agencies, NGOs for the cultural adaptation of the IYG program) and quantitative data (usability and pilot tests with adolescents in Andalusia and Catalonia). Data, in text and table formats, will be stored in the DIGIBUG repository (Qualified Dublin Core metadata, unique identifier, version control). They will be accessible after processing, except those protected by personal data regulations, which will be embargoed. No raw or sociodemographic data will be published. Materials will have a Creative Commons license and may be reused after project completion, with up to 3 years embargo for doctoral theses. DIGIBUG will perform backups and ensure security. Data will be pseudonymized or anonymized (AMNESIA tool) and owned by the PI, who will ensure legal and ethical compliance.
Supporting information: Statistical analysis plan
Time frame: Materials will have a Creative Commons license and may be reused after project completion, with up to 3 years embargo for doctoral theses.
Access criteria: Raw data will only be available to the research team. Ownership of the data will rest with the project's Principal Investigator, who will ensure that no variables are transferred.
Start is estimated for Oct 2025; primary completion for Jun 2027, 20 months later.
Of 106 non-industry interventional studies with no phase under Sexual Behavior, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 20 months is below that.
Counting every sponsor, half of 107 studies reached it within 23 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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