Adolescent Health, Condom Use, Cultural Adaptation, Sexual Behavior, Sexually Transmitted Disease (STD)
Conditions
Keywords
sexually behaviour, sex education, adolescents, health education, cultural adaptation, evidence-based prevention, school health
Brief summary
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 Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.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.
Interventions
BEHAVIORALEs tu juego: decide bien (IYG)
Affective-sexual education for adolescents through an gamified online and school-based program.
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The pilot effectiveness study will be conducted through a randomised community trial with a Control Group (CG) and an Intervention Group (IG). For sample size calculation, assuming an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 300 participants are required in the first group and 300 in the second to detect a statistically significant difference between two proportions, expected to be 0.2 for group 1 and 0.1 for group 2. A 30% loss to follow-up rate has been estimated. So it is expected to recruit 600 students in each Region, Andalusia and Catalonia. The assignment of the Control Group (CG) and Intervention Group (IG) will be carried out through simple randomisation. For allocation, each educational centre will be assigned a number, and a random number generator will be used to determine its inclusion in either the CG or IG. Participants in the CG will remain on a waiting list to receive the intervention, which will be implemented once the project is completed.
Eligibility
Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Presence of linguistic, cognitive, or sensory barriers that prevent completion of the questionnaire * Participation in another programme aimed at preventing affective-sexual risk behaviours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) | 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 |
Countries
Spain
Contacts
Primary ContactAlba Sierra Yagüe, PhD student. Nurse
Backup ContactMarta Lima Serrano, Full professor
Outcome results
None listed