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
Phase: NA
Conditions: Sexual Behavior, Sexually Transmitted Disease (STD), Condom Use, Adolescent Health, Cultural Adaptation
Sponsor: University of Seville

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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 
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METHODS 
Intervention 
It’s Your Game: Keep It Real (IYG) is an evidence-based hybrid educational game that combines 
face-to-face classroom sessions with digital modules delivered on school-based computers. The 
programme targets students of Grade 7 (aged 12 to 13 years) and Grade 8 (aged 13 to 14 years) 
in the United States of America - the equivalent in Spain is 1st (aged 12 to 13 years) and 2nd 
years (aged 13 to 14 years) of compulsory secondary education (ESO)- and is structured across 
two levels: Level I for Grade 7 students and Level II for Grade 8 students. Each level consists of 
twelve 45-minute sessions. Of these, eight are classroom-based and facilitated by a trained teacher 
through interactive methods such as group discussions and role-playing. The remaining four 
sessions in each level are computer-based and delivered via a virtual world interface that 
incorporates quizzes, animations, peer-led videos, and informational materials. For the virtual 
component, the use of the platform will be coordinated with the original developers of the 
programme. The adaptation may build on the platform educa tailor©, previously employed in the 
Alerta Cannabis project, which offers tailored guidance to users based on their individual needs 
(1). 
IYG is grounded in three theoretical frameworks: Bandura’s Social Learning Theory and Social 
Cognitive Theory (2), Social Influence Models (3,4) and the Theory of Triadic Influence by Flay 
and Petraitis (5). Social Learning Theory emphasises the interplay of personal cognition, 
behaviour, and environmental factors, with self-efficacy being central to behavioural change. 
Learning occurs through attention, focus, and motivation, with reinforcement playing a key role. 
Social Influence Models highlight how interpersonal interactions can shape beliefs, motivations, 
and behaviours. The Theory of Triadic Influence considers multiple levels of influence—cultural-
environmental, contextual-situational, and intrapersonal—interacting to shape behaviour. With 
the aim of delaying the age of sexual intercourse and reducing sexual risk behaviours, IYG 
supports adolescents in identifying personal norms and boundaries regarding sexuality, 
recognising scenarios that may challenge those boundaries, and acquiring refusal skills to help 
maintain them. The programme also addresses a wide range of related topics, including the 
characteristics of healthy and unhealthy relationships, friendships, reproductive anatomy and 
physiology, the social, emotional, and physical consequences of sexual activity, teenage 
pregnancy and STIs, condom and contraceptive use, and communication skills (6). 
Cultural Adaptation of the IYG Program 
The cultural adaptation of the IYG programme in this study is guided by the findings of a recently 
published scoping review conducted by the research team (7). Based on this comprehensive 
review, the adaptation process employs three conceptual frameworks: the Ecological Validity 
Model, the Cultural Sensitivity Framework and IM-Adapt, which were previously used to adapt 
interventions in the field of sexual health (8–10). The Ecological Validity Model proposes eight 
dimensions to guide culturally relevant intervention adaptation: language, persons, metaphors, 
content, concepts, goals, methods, and context (8). The Cultural Sensitivity Framework 
distinguishes between two levels of adaptation: surface-level adaptations, which refer to visible 
and cultural adjustments e.g. names, images, language, and deep-level adaptations, which address 
underlying cultural values and meanings (9). The Intervention Mapping for Adaptation (IM-
Adapt) comprises six steps: the assessment of needs, the search for existing interventions, the 
evaluation of cultural fit and the planning of adaptations, the implementation of these adaptations, 
the planning for delivery, and, finally, the planning for evaluation. This process ensures that the 
intervention retains its scientific foundation while being rigorously tailored to the characteristics 
and context of the target population. Finally, the recent review conducted by our colleagues 
identifies eleven steps that should be considered in the adaptation of evidence-based programmes 
(10). 

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The adaptation process uses a co-design approach and community-based participatory research, 
actively involves adolescents, families, teachers, primary care and school nurses, and other key 
stakeholders in the different phases of the review and refinement of the programme. This 
bidirectional collaboration ensures that the modifications faithfully reflect the realities, priorities, 
and cultural contexts of the participating communities, thereby guaranteeing the programme’s 
relevance, acceptability, and long-term sustainability (11,12). 
A mixed-methods approach guides the adaptation process, integrating qualitative and quantitative 
methodologies (13,14). This approach is optimal for achieving a culturally responsive and 
evidence-informed intervention. The qualitative component explores the experiences of 
adolescents, families, and facilitators, and provides insight into the programme’s social 
validation, perceived usability, utility, and feasibility. The quantitative component assesses 
effectiveness in delaying sexual initiation and other key behavioural indicators through a 
community-based trial. The interaction of both components informs the utility and relevance of 
the adapted programme. 
Bringing together all this information, the project unfolds in two phases. The first focuses on the 
cultural adaptation and validation of the programme content in three steps, and the second 
involves the pilot implementation and evaluation of the adapted intervention. Participating 
schools are selected from different areas of Granada (Andalusia) and Barcelona (Catalonia), 
considering accessibility and the establishment of a stakeholder network. The target population 
comprises students in the first and second years of compulsory secondary education (E.S.O.) in 
publicly funded secondary schools. Inclusion criteria specify that adolescents are aged 11–14 
years and have access to a computer and internet at school. Students are excluded if they present 
linguistic, cognitive, or sensory difficulties that hinder completion of the intervention or 
questionnaires, or if their schools participate in another programme aimed at preventing affective–
sexual risk behaviours. 
Phase 1: Initial Cultural Adaptation and Pilot Usability Study for Social Validation 
This phase comprises three sub-phases: the development of initial changes and the first draft of 
the programme, facilitator training, pilot testing, and refinement of the initial adaptation. 
 
Phase 1. Stage 1. Initial changes and first draft of the programme. 
The original materials are translated and back translated. Following the literature and COREQ 
criteria (15), Focus Groups (FGs) are conducted with adolescents to incorporate contextual and 
sociocultural factors related to sexual risk behaviours in Andalusia (Granada) and Catalonia 
(municipalities from Barcelona: Santa Coloma de Gramanet, Abrera and Badalona),  and a first 
draft is developed by the research group in collaboration with the creators of the IYG programme 
and other relevant stakeholders from the intervention site, such as primary care nurses, school 
nurses, school teachers, or psychologists, who constitute the community advisory group. This 
initial adaptation draft of the programme incorporates the necessary modifications to tailor it to 
the context and characteristics of the target population, ensuring that the adaptations maintain 
fidelity to the original content while addressing the identified needs. 
 
The FGs are composed of adolescents selected through theoretical and snowball sampling to 
ensure heterogeneity and gender balance, with the aim of identifying potential differences that 
may need to be considered in the adaptation of the intervention. A minimum of 10 FGs is 
expected, with the number adjusted according to data saturation. Each group consists of six to 
eight participants (16). Once schools agree to participate and parental and adolescent informed 
consent are obtained the FCs take place during school hours. A script is used based on the 

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principles of the IYG programme and the Ecological Validity, Cultural Sensitivity Models and 
IM-Adapt (8–10). To enhance the relevance and contextual appropriateness of the adapted 
intervention, the exploration of sexual behaviours and perceptions is integrated with the 
presentation of selected programme content. This approach enables participants to provide 
feedback that is grounded not only in general attitudes but also in direct responses to specific 
examples, activities, and messages from the intervention. FGs are also conducted with parents, 
recognising their central role in adolescent sexual health education and the sustainability of 
preventive programmes. Engaging parents helps to identify potential resistance, align the 
programme with family values and expectations, and foster active family involvement in 
supporting adolescents’ healthy decision-making (17,18).  
 
Data collected from the FGs are transcribed and subjected to content analysis, categorised into 
categories and subcategories. This process is carried out independently by two researchers to 
ensure methodological rigour. The analysis is conducted using version 14 of NVivo software. 
 
Phase 1. Stage 2. Selection and training of facilitators. 
The facilitators are the adolescents’ teachers or nurses providing care in schools (19), depending 
on the local context, and are responsible for implementing the IYG programme in the educational 
centres and for interacting directly with the adolescents.  Their training is based on the guidelines 
provided by the creators of IYG. They receive specific training on the IYG programme, its 
structure, objectives, and content over a period of two days. 
 
Phase 1. Stage 3. Pilot usability study  
 
A usability test is conducted based on previous adaptations (20,21), and the recommendations of 
Virzi and Nielsen (22). 50 students (25 per school level 1 and 2) from secondary schools in 
Andalusia and Catalonia participate.  
 
The adapted draft of the IYG programme developed by Tortolero, Markham, Peskin and Shegog 
will be used. All 24 lessons are evaluated over six weeks (two lessons per week). Before the first 
lesson, a sociodemographic questionnaire is administered. After each lesson, a usability 
questionnaire is applied, including open-ended items (20,23). Likert-type scales are employed to 
assess the following elements: (1) Ease of use, with a scale ranging from “very easy”, “somewhat 
easy”, “somewhat difficult”, “very difficult”. (2) Credibility (accuracy of content), assessed with 
the options “correct”, “incorrect”, “don’t know”. (3) Comprehension (understanding of words and 
language used), motivational appeal (whether participants use IYG again and recommend it), and 
perceived impact (whether it helps them make healthy decisions about sexual relationships and 
friendships), assessed with the responses “yes”, “no”, “don’t know”. (4) Acceptability (pace of 
activities), assessed with “too fast”, “just right”, “too slow”. The Thinking Aloud method is 
employed to identify usability or comprehension issues, and to detect points of friction or errors 
in the interface, instructions, or content (24). 
 
Open-ended items provide complementary information on content quality, digital support, 
preferred and disliked elements, and suggestions for improvement. Fidelity is assessed through 
random observation of sessions by a researcher. Teachers and researchers complete monitoring 
forms for each session to evaluate quality, difficulties, positive effects, and student responses. 
These forms follow the FRAME model (Framework to Report Adaptation and Modifications–
Expanded) (25), documenting modifications, their timing, context, actors, and rationale. 

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Data analysis considers descriptive parameters. Likert scales are transformed into dichotomous 
variables, and exact binomial probabilities are calculated for each item (23). This strategy 
evaluates response distributions and identifies significant patterns in usability, credibility, 
comprehension, motivational appeal, impact, and acceptability. Separate analyses are conducted 
by gender. Open-ended responses are categorised by thematic area. 
 
Phase 2: Implementation, Evaluation, and Monitoring 
This phase focuses on implementation, evaluation, and monitoring. The effectiveness of the 
programme is assessed through a community trial, concluding with dissemination of the results 
to support sustainability. The refined version is implemented in a randomised community trial 
with a wait-list control group (CG) and an intervention group (IG). A 24-month follow-up is 
conducted, corresponding to the full duration of implementation, as each programme level (first 
and second year of secondary school) lasts 12 months. The IG receives the IYG intervention, 
while the CG continues with usual education and both complete questionnaires at baseline and 
follow-ups. At the beginning, as in the usability testing, facilitators are trained by researchers over 
two days. 
Cluster sampling is used. The sample size is calculated with the online GRANMO calculator 
(https://www.datarus.eu/aplicaciones/granmo/). Considering the onset of sexual intercourse as the 
primary outcome and accepting an alpha risk of 0.05 and a statistical power greater than 0.8 in a 
two-sided test to detect a difference between proportions of 0.2 in the unexposed group and 0.1 
in the exposed group, three clusters per group are required, with 100 participants in each cluster 
(a total of six clusters and 600 participants). A very low cluster effect is assumed (intraclass 
correlation coefficient [ICC] = 0.001), along with a 30% loss rate. The crtpwr.2prop function 
from the clusterPower package in R is applied. 
Assignment of the wait-list control group (CG) and intervention group (IG) is performed through 
simple randomisation. Each educational centre is assigned a number, and a random number 
generator determines its inclusion in either CG or IG, with approximately three schools per arm. 
Participants in the CG remain on a waiting list to receive the intervention once the project is 
completed This outcome is assessed through three separate questions addressing oral, vaginal, 
and anal sex. 
Considering previous research on the IYG programme, school surveys are administered at 
different time points.  Follow-up records are maintained for IG participants over the 24-month 
duration of the programme, covering both Level 1 and Level. Questionnaires are administered at 
four time points— baseline, at the end of the first and second school year of the intervention, and 
at the end of the following year —preferably in a computer-based format, with a paper version 
available if required. These questionnaires are administered by trained researchers and are carried 
out during school hours. Both the intervention and the questionnaires will be delivered in tutorial 
sessions or integrated into subjects related to life skills (6,20,21,23).  
The primary outcome variable is the delay in initiation of sexual activity among participants who 
have not engaged in sexual intercourse at baseline (26,27). This outcome is assessed through three 
separate questions addressing oral, vaginal, and anal sex. In addition to the primary outcome, the 
study examines a range of secondary variables across several domains. For affective–sexual 
behaviours, these include late initiation of specific types of sexual activity; lifetime number of 
sexual partners; current sexual activity (defined as sexual intercourse within the past three 

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months); frequency of unprotected sex; number of partners within the past three months; number 
of partners without condom use in the same period; and condom use during the most recent sexual 
encounter. 
Psychosocial individual factors encompass knowledge about sexually transmitted infections 
(STIs) and condoms; beliefs about abstinence and condom use; perceptions of friends’ attitudes 
towards abstinence; perceived peer norms related to sexual behaviour; self-efficacy in refusing 
sex and using condoms; intentions to engage in sexual activity, to remain abstinent, and to use 
condoms; reasons for not having sex; global character attributes; future orientation; and the 
number of personal boundaries established. Environmental factors focus on exposure to situations 
that may lead to sexual activity, as well as communication with parents or guardians about sex. 
Sociodemographic variables are collected, including city of residence, age, sex, gender identity, 
parents’ or guardians’ educational level, socioeconomic status, and family functioning, which are 
considered potential confounding factors. 
To assess fidelity and quality of implementation, 12 sessions are randomly selected and observed 
over the 24-month period, including the first and last sessions. These observations involve 
researchers, external evaluators, and the promoting group. Facilitators complete checklists and a 
field diary after each session, using documentation provided by the programme creators. A data 
management plan is implemented to ensure appropriate use of collected data. The forms follow 
the FRAME model (Framework to Report Adaptation and Modifications–Expanded) (25), which 
documents modifications to the original programme, specifying when, where, by whom, and why 
each adaptation is made. 
A descriptive analysis is carried out to examine differences between the intervention group and 
the wait-list control group using Student’s t-test and the chi-square test. A multilevel multivariate 
analysis with generalised linear models assesses the effect of the programme on sexual initiation 
and other secondary outcomes. Sociodemographic variables are included as covariates. A 
significance level of p < .05 is applied. Effect sizes (Pearson’s r and odds ratios) and 95% 
confidence intervals are calculated. Statistical analyses are performed using SPSS v31 and R 
4.5.1. Differential effects by age, sex/gender identity, socioeconomic status, and family 
functioning are explored. 
Below is the figure 1 illustrating the implementation and evaluation of the IYG programme 
through a cluster randomised community trial. 
Figure 1. Flowchart – Phase 2: Implementation, Evaluation, and Monitoring 

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