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

NCT07208045 | Not Yet Recruiting

• 1 other identifier: IYG2024
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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 Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.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

Conditions

Sexual Behavior; Sexually Transmitted Disease (STD); Condom Use; Adolescent Health; Cultural Adaptation

Keywords

sexually behaviour; sex education; adolescents; health education; cultural adaptation; evidence-based prevention; school health

Outcome Measures

Primary Outcomes (1)

• 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

  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)

Study Arms (2)

Intervention group IYG

EXPERIMENTAL

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)

Waiting list control group

NO INTERVENTION

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.

Interventions

Es tu juego: decide bien (IYG) BEHAVIORAL

Affective-sexual education for adolescents through an gamified online and school-based program.

Intervention group IYG

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

IES Numancia

Barcelona, Santa Coloma de Gramenet, 08921, Spain

Location

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MeSH Terms

Conditions

Sexual Behavior; Sexually Transmitted Diseases; Health Education

Condition Hierarchy (Ancestors)

Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Alba Sierra Yagüe, Phd Student

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

• Marta Lima Serrano, Full professor

  University of Seville

  STUDY DIRECTOR

• José Antonio Zafra Agea, PhD

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

• Ana Aguilar Quesada, PhD Student

  San Cecilio University Hospital, Granada

  PRINCIPAL INVESTIGATOR

• María González Cano Caballero, PhD

  department of Nursing, Faculty of Health Sciences, University of Granada.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Sierra Yagüe, PhD student. Nurse

CONTACT

652260353; Albbii.sy@gmail.com

Marta Lima Serrano, Full professor

CONTACT

mlima@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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.

Locations

ES (1)