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

University of Seville

Status: Not yet enrolling

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

Treatments: Behavioral: Es tu juego: decide bien (IYG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07208045

IYG2024

Details and patient eligibility

About

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Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Intervention group IYG

Experimental group

Description:

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.

Treatment:

Behavioral: Es tu juego: decide bien (IYG)

Waiting list control group

No Intervention group

Description:

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.