Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents (IYG)

Официальное название

Es tu Juego: Decide Bien [It's Your Game: Keep It Real]. Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents

Обзор

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 Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.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.

Вмешательства

• Поведенческое Es tu juego: decide bien (IYG)
  Affective-sexual education for adolescents through an gamified online and school-based program.

Первичные конечные точки

• 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. [Срок оценки: 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)]

Критерии участия

Критерии включения

• Adolescents aged between 11 and 14 years enrolled in compulsory secondary education (E.S.O).
• Access to a computer and internet at their educational centre.

Критерии исключения

• Presence of linguistic, cognitive, or sensory barriers that prevent completion of the questionnaire
• Participation in another programme aimed at preventing affective-sexual risk behaviours.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• IES Numancia — Barcelona

Публикации

• Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y. PMID 31171014
• Lucassen MF, Samra R, Brown KE, Rimes KA, Nunez-Garcia A, Wallace LM. A web-based intervention to support the mental well-being of sexual and gender minoritised adolescents: Formative evaluation of Oneself. Digit Health. 2025 Mar 13;11:20552076251321057. doi: 10.1177/20552076251321057. eCollection 2025 Jan-Dec. PMID 40093712
• Escobar-Chaves SL, Shegog R, Moscoso-Alvarez MR, Markham C, Tortolero-Luna G, Peskin M, Tortolero S. Cultural tailoring and feasibility assessment of a sexual health middle school curriculum: a pilot test in Puerto Rico. J Sch Health. 2011 Aug;81(8):477-84. doi: 10.1111/j.1746-1561.2011.00617.x. PMID 21740433
• Virzi RA. Refining the Test Phase of Usability Evaluation: How Many Subjects Is Enough? Human Factors: The Journal of the Human Factors and Ergonomics Society. 1992; 1; 34(4): 457-68. https://2024.sci-hub.box/3857/2afb54700f6961ae637e388c3f96891c/virzi1992.pdf
• Vargas-Martinez AM, Guillen-Martinez D, Domingo Perez T, Soilan Enriquez A, Zafra-Agea JA, Hoyos Cillero I, Lima-Serrano M, Tarrino-Concejero L. Analysis of the management function of the school nurse in Spain: use of records and interaction with primary care, the educational community and other institutions. Enferm Clin (Engl Ed). 2025 Sep-Oct;35(5):502200. doi: 10.1016/j.enfcle.2025.502200. Epub PMID 40412717
• Agyei FB, Kaura DK, Bell JD. Parent-adolescent sexual and reproductive health information communication in Ghana. Reprod Health. 2025 Feb 19;22(1):25. doi: 10.1186/s12978-025-01961-y. PMID 39972503
• Mukanga B, Dlamini SB, Taylor M. Cultural appropriateness of a comprehensive sexuality education programme. Implications for programme adaptation and implementation in Zambia. Sex Educ. 2025; 3;25(5): 631-46. https://doi.org/10.1080/14681811.2024.2367761
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Идентификаторы

NCT: NCT07208045 · IYG2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗