NCT07208045: IYG

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

Not yet recruiting NA Last updated 8 October 2025

What this trial tests

NA trial testing Es tu juego: decide bien (IYG) in Sexual Behavior in 1,200 participants. Not yet recruiting.

Timeline

1 October 2025

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	University of Seville
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,200
Start date	1 October 2025
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	1 location across Spain

Drugs / interventions tested

• Es tu juego: decide bien (IYG)

Conditions studied

• Sexual Behavior — all drugs for Sexual Behavior →
• Sexually Transmitted Disease (STD) — all drugs for Sexually Transmitted Disease (STD) →
• Condom Use — all drugs for Condom Use →
• Adolescent Health — all drugs for Adolescent Health →

Sponsor

University of Seville

Who can join

Adults 11 to 14, any sex, with Sexual Behavior or Sexually Transmitted Disease (STD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.