Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents (IYG)
NCT ID: NCT07208045
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1200 participants
INTERVENTIONAL
2025-10-01
2027-06-30
Brief Summary
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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Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group IYG
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.
Es tu juego: decide bien (IYG)
Affective-sexual education for adolescents through an gamified online and school-based program.
Waiting list control group
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.
No interventions assigned to this group
Interventions
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Es tu juego: decide bien (IYG)
Affective-sexual education for adolescents through an gamified online and school-based program.
Eligibility Criteria
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Inclusion Criteria
* Access to a computer and internet at their educational centre.
Exclusion Criteria
* Participation in another programme aimed at preventing affective-sexual risk behaviours.
11 Years
14 Years
ALL
Yes
Sponsors
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University of Seville
OTHER
Responsible Party
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Marta Lima-Serrano, PhD
Full professor
Principal Investigators
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Alba Sierra Yagüe, Phd Student
Role: PRINCIPAL_INVESTIGATOR
Catalan Institute of Health
Marta Lima Serrano, Full professor
Role: STUDY_DIRECTOR
University of Seville
José Antonio Zafra Agea, PhD
Role: PRINCIPAL_INVESTIGATOR
Catalan Institute of Health
Ana Aguilar Quesada, PhD Student
Role: PRINCIPAL_INVESTIGATOR
San Cecilio University Hospital, Granada
María González Cano Caballero, PhD
Role: PRINCIPAL_INVESTIGATOR
department of Nursing, Faculty of Health Sciences, University of Granada.
Locations
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IES Numancia
Barcelona, Santa Coloma de Gramenet, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Muheriwa-Matemba S, Crooks N, Hall H et al. 156. Fostering Young Adolescent Engagement in Sexual Health Research: A Youth-Led Community-Based Participatory Research in Western NY. Journal of Adolescent Health. 2025; 76(3): S81. doi: 10.1016/j.jadohealth.2024.11.172
Meherali S, Munro S, Puinean G, Salami B, Wong JP, Vandermorris A, Benoit JRA, Flicker S, Okeke-Ihejirika P, Stroulia E, Norman WV, Scott SD. Co-designing a Sexual Health App With Immigrant Adolescents: Protocol for a Qualitative Community-Based Participatory Action Research Study. JMIR Res Protoc. 2023 Mar 22;12:e45389. doi: 10.2196/45389.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Infomed consent
Other Identifiers
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IYG2024
Identifier Type: -
Identifier Source: org_study_id
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