An interventional study of Community-Based Component and Adolescent Mindfulness Component in Video Game Addiction and Gaming Disorder, sponsored by Fundacin Biomedica Galicia Sur. Active, not recruiting at 1 site in Spain. Open to participants aged 11 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Fundacin Biomedica Galicia Sur · Not applicable, Interventional, and Treatment
This cluster randomised controlled trial will evaluate whether a community-based, multicomponent intervention can reduce problematic video game use and gaming disorder among first-year secondary school students in Pontevedra, Spain.
The intervention combines three coordinated components: a participatory community programme in which adolescents identify local leisure resources and co-design healthy screen-free activities; a classroom-based mindfulness programme for adolescents; and an online mindfulness programme for parents, caregivers, teachers, healthcare professionals, and other adults in the adolescents' environment.
Schools will be randomly assigned to either the intervention group or a control group that continues with usual educational practice. Adolescents will be assessed before the intervention, after the intervention, and at 6-month follow-up. Adults will be assessed before and after the intervention.
The main hypothesis is that adolescents in intervention schools will show a greater reduction in problematic video game use and gaming disorder than adolescents in control schools. The study will also examine whether the intervention improves mindfulness, psychological well-being, perceived social support, and self-regulation, and reduces impulsivity and involvement in cyberbullying. In addition, it will explore whether changes in mindfulness and other psychological factors help explain the intervention's effects, and whether family involvement, adult mindfulness, cyberbullying, and baseline severity influence the results.
Video games are a widespread form of leisure among adolescents and may provide entertainment, opportunities for social interaction, and experiences of competence when used in a balanced manner. However, problematic use can interfere with daily functioning and has been associated with psychological, behavioural, academic, physical, and social difficulties. Gaming disorder is recognised as a mental health condition in the International Classification of Diseases, while internet gaming disorder remains a condition requiring further research in the Diagnostic and Statistical Manual of Mental Disorders. In this study, gaming-related problems are considered regardless of whether video games are played online or offline.
Adolescence is a particularly relevant developmental period because patterns of leisure, emotional regulation, coping, and social behaviour are still being established. Problematic video game use is understood as a multifactorial phenomenon resulting from the interaction of game-related characteristics, individual vulnerabilities, and environmental influences. Relevant individual factors may include impulsivity, difficulties with emotional regulation, psychological distress, and the use of gaming as a way to escape or cope with negative experiences. Family relationships, peer interactions, school environments, perceived social support, cyberbullying, and access to meaningful leisure alternatives may also contribute to either increasing or reducing risk.
The intervention is therefore based on a developmental, systemic, and socioecological perspective. Rather than focusing exclusively on adolescents' individual behaviour, it addresses several levels of their immediate environment, including the family, school, healthcare, and community contexts. The theoretical model integrates principles from mindfulness-based stress reduction, mindfulness-based cognitive therapy, cognitive-behavioural approaches, family involvement, ecological systems theory, and participatory community development. Mindfulness is expected to strengthen attentional, emotional, and behavioural self-regulation, while cognitive-behavioural strategies may help participants identify and modify maladaptive thoughts, avoidance patterns, and coping responses associated with problematic gaming.
The study is a two-arm cluster randomised controlled trial conducted in publicly funded secondary schools in the province of Pontevedra, Galicia, Spain. Randomisation is performed at the school level to reduce contamination between students receiving different study conditions. Participating schools are assigned either to an intervention group, which receives the multicomponent programme, or to a control group, which continues with usual educational practice during the study period. Because of the nature of the intervention, adolescents, educational staff, families, and community agents cannot be blinded to group allocation. Outcome analysis will, however, be conducted under blinded conditions.
The target population consists of students enrolled in the first year of compulsory secondary education. Adults from the adolescents' immediate environment may also participate, including parents or legal guardians, caregivers, teachers, healthcare professionals, and community representatives involved in the school-based coordinating groups.
The required adolescent sample size is 364 participants. The calculation assumes a two-sided significance level of 0.05, statistical power of 80%, and a small-to-moderate expected effect size of Cohen's d = 0.35. The initial estimate was adjusted to account for clustering at the school level and an anticipated attrition rate of 15%.
The intervention comprises three coordinated components: a participatory community component, a classroom-based mindfulness programme for adolescents, and an online mindfulness programme for adults. Although the components form a single multicomponent intervention, standardised procedures will be developed for each component to support implementation fidelity, reproducibility, and evaluation.
The community component is based on participatory action research and aims to involve adolescents actively in identifying local needs, recognising community assets, and co-designing healthy leisure alternatives. Core procedures, including the number and duration of sessions, participatory techniques, facilitation procedures, and documentation requirements, will be standardised across participating schools. At the same time, the specific community resources, needs, and leisure proposals identified by students will be adapted to the context of each school and local area.
This component consists of three face-to-face group sessions of approximately 50 minutes each, delivered in the classroom by trained professionals from the research team, including medical and nursing residents and researchers.
During the first session, students are introduced to the project and to two participatory methods: community mapping and photovoice. These techniques are used to help participants explore their everyday leisure environments, identify meaningful locations and activities, and reflect on the value of available community resources. Between sessions, students produce three to five photographs accompanied by brief explanatory narratives and contribute to a collective classroom map.
The second session focuses on collective analysis of the photographs and community map. Students work in small groups to identify existing leisure resources, perceived needs, barriers, and opportunities for improving adolescent leisure. The group contributions are then integrated into a collective inventory of community assets and needs.
During the third session, the proposals generated by the students are organised into thematic categories and prioritised through an individual voting process. The two proposals considered most relevant are developed further in a group assembly, during which students define their format, content, feasibility, and possible alternatives. The process concludes with the co-design of two community-based healthy leisure events. The research and facilitation team is responsible for supporting the logistical organisation and feasibility of the selected activities.
The community component is intended to move beyond consultation by giving adolescents an active role in decision-making and action. It seeks to increase their awareness of available community resources, strengthen their sense of participation, and promote appealing leisure alternatives that do not depend on screens or video games.
The adolescent component is a structured mindfulness programme adapted to the educational context and based on established mindfulness-based stress reduction and mindfulness-based cognitive therapy principles. Its main purpose is to promote socio-emotional development and strengthen attentional and emotional self-regulation.
The programme consists of eight face-to-face group sessions of approximately 50 minutes, delivered in the classroom during school hours. Content follows a progressive sequence addressing awareness of the body and breathing, physical sensations, emotions, thoughts, and open awareness. The gradual structure is intended to help students acquire practical mindfulness skills that can be applied to everyday situations.
In addition to the formal sessions, brief mindfulness practices may be incorporated into other moments and settings within school life. This cross-cutting approach is intended to facilitate the transfer of skills beyond the intervention sessions and encourage their use in situations involving stress, emotional discomfort, impulsive reactions, or difficulties with attention.
The adult component is intended for parents, legal guardians, caregivers, teachers, healthcare professionals, and other adults involved in the adolescents' immediate environment. It is delivered as an individual, self-guided online programme that can be accessed through digital devices.
The programme comprises six sessions of approximately 45 minutes each and is designed to be completed over an estimated period of eight weeks. Participants may progress at their own pace within this timeframe. The content combines mindfulness practices with cognitive-behavioural strategies.
This component aims to improve adults' mindfulness and psychological well-being and to provide them with practical tools for supporting adolescents. By strengthening adults' emotional regulation, mindful responding, communication, and capacity to provide consistent support, the programme is expected to contribute to a family and community environment that reinforces healthy boundaries, emotional co-regulation, and balanced leisure habits.
A coordinating group will be established in each participating school. It will include an assigned researcher, a student representative, a family representative, a member of the teaching staff, a community agent, and the paediatrician corresponding to the school's healthcare area.
These groups will facilitate communication between the research team, schools, families, healthcare professionals, and community stakeholders. They will also support intervention adherence, participant engagement, and retention throughout the study.
Implementation fidelity will be assessed using attendance records, structured session documentation, and facilitator checklists. These materials will record the activities completed, adaptations introduced, participant attendance, and contextual factors that may influence implementation. Adherence, withdrawals, and adverse events will also be documented.
Adolescents are assessed before the intervention, immediately after the intervention, and at a six-month follow-up. Adults complete assessments before and after the intervention. The assessment strategy is intended to determine whether changes are maintained over time and to examine both the overall intervention effect and the possible mechanisms through which change occurs.
The principal hypothesis is that adolescents attending intervention schools will show a greater reduction in problematic video game use and gaming disorder than adolescents attending control schools. Improvements are also expected in mindfulness, psychological well-being, perceived social support, and emotional and behavioural self-regulation, together with reductions in impulsivity and involvement in cyberbullying. Adults participating in the intervention are expected to show increased mindfulness.
The study will additionally explore whether changes in adolescent mindfulness, psychological well-being, perceived social support, and impulsivity help explain the effect of the intervention on problematic gaming. Cyberbullying will be examined as a contextual factor because gaming may serve as an avoidant or compensatory coping strategy among adolescents experiencing peer victimisation or interpersonal distress.
Potential moderators of intervention effectiveness will include active family or caregiver participation, mindfulness among adults in the adolescent's environment, involvement in cyberbullying, and the initial severity of problematic video game use. Greater family involvement and higher adult mindfulness are expected to facilitate intervention effects, whereas greater baseline severity and higher involvement in cyberbullying may be associated with a weaker response or a need for more intensive support.
Questionnaire data will be collected through REDCap using coded participant identifiers. Identifying information and research data will be stored in separate databases operating on different systems. The correspondence between participant identity and study code will be managed separately, thereby reducing the possibility of direct identification and strengthening confidentiality and data protection.
The main effectiveness analyses will follow the intention-to-treat principle. Because randomisation occurs at the school level, multilevel mixed-effects models will be used to account for the clustered structure of the data and repeated assessments over time. The primary intervention effect will be estimated using group-by-time interaction terms.
Missing data will be addressed using multiple imputation methods appropriate for multilevel data, under a missing-at-random assumption. Data quality procedures will include the examination of outliers, irregular response patterns, floor and ceiling effects, acquiescence, and apparently random responses. Sociodemographic variables will be considered as covariates where appropriate.
Exploratory mediation analyses will use longitudinal multilevel structural equation modelling to examine whether post-intervention changes in psychological variables are associated with later changes in problematic gaming. Moderation analyses will include interaction terms between study group and the proposed individual or contextual moderators. Multiple comparisons will be adjusted using the Holm-Bonferroni procedure, and exploratory findings will be interpreted cautiously because of the statistical limitations associated with the clustered design.
In the absence of closely comparable previous interventions, a preliminary indicator of success has been defined as a 30% reduction in the prevalence of problematic video game use in the intervention group compared with the control group.
By integrating adolescent mindfulness training, adult involvement, school participation, and community action, the study seeks to evaluate a comprehensive approach that addresses both individual self-regulation and the wider environments in which adolescent gaming behaviour develops.
22 studies on the registry are indexed under Technology Addiction; 3 are open to participants now.
This study's enrollment of 492 is above the median of 83 across 14 interventional studies indexed under Technology Addiction.
Browse Technology Addiction studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Educational Centres
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Adolescents
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Adults
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm include first-year secondary school students attending educational centres assigned to the intervention group, together with participating adults from the adolescents' immediate environment. Adolescents receive a coordinated multicomponent intervention comprising: (1) a participatory community-based programme in which they identify local leisure resources and co-design healthy, screen-free activities; and (2) a structured classroom-based mindfulness programme aimed at strengthening attention, emotional awareness, and self-regulation. Participating adults (including family members, caregivers, teachers, healthcare professionals, and community representatives) complete an individual, self-guided online programme combining mindfulness practices with cognitive-behavioural strategies. All intervention components are delivered in addition to usual educational activities.
Behavioral: Community-Based Component · Behavioral: Adolescent Mindfulness Component · Behavioral: Adult Mindfulness Component
Participants in this arm include first-year secondary school students attending educational centres assigned to the control group. They do not receive any of the multicomponent intervention activities and continue with usual educational practice throughout the study period. Control-group participants complete the study assessments at the predefined time points to allow comparison with participants from intervention schools.
The community component is based on participatory action research and actively involves adolescents in identifying local leisure needs, recognising community assets, and co-designing healthy screen-free alternatives. It consists of three 50-minute classroom sessions facilitated by trained members of the research team. Students use community mapping and photovoice to explore their everyday leisure environments, produce photographs with short narratives, and contribute to a collective map. The materials are then discussed in small groups to identify available resources, barriers, and opportunities for improvement. Finally, students prioritise the proposals through voting and jointly develop two feasible community-based leisure activities. The core structure is standardised across schools, while the specific content and activities are adapted to each local context. Attendance, adaptations, and implementation fidelity are recorded throughout the process.
The adolescent mindfulness component is a structured classroom-based programme adapted from established Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy protocols. It aims to strengthen attention, emotional awareness, and behavioural self-regulation. The programme consists of eight face-to-face group sessions of approximately 50 minutes, delivered during school hours. Content follows a progressive sequence focused on awareness of the body and breathing, physical sensations, emotions, thoughts, and open awareness. Sessions combine guided mindfulness practices with age-appropriate reflection and discussion, helping students recognise internal experiences and respond to them in a less automatic way. Brief mindfulness exercises are also encouraged in other school settings to support the transfer of skills to daily life. No minimum group size is required, and the intervention is delivered in addition to usual educational activities.
The adult mindfulness component is an individual, self-guided online programme for parents, caregivers, teachers, healthcare professionals, and community representatives in the adolescents' immediate environment. It aims to improve participants' mindfulness and psychological well-being while providing practical tools to support adolescents in developing healthier leisure habits. The programme consists of six sessions of approximately 45 minutes each and is designed to be completed over eight weeks at the participant's own pace. Its content combines mindfulness practices with cognitive-behavioural strategies focused on emotional regulation, stress management, self-awareness, and more mindful responses in everyday situations. The programme is accessed through digital devices, requires no minimum number of participants, and is intended to strengthen adults' role as supportive models within adolescents' family, school, healthcare, and community environments.
Problematic Video Game Use and Game Addiction
Change in problematic video game use and gaming disorder symptoms among adolescents, assessed using the validated Spanish versions of the Game Addiction Scale for Adolescents (GASA) and the Ten-Item Internet Gaming Disorder Test (IGDT-10). The GASA is a seven-item self-report instrument. Total scores range from 7 to 35, with higher scores indicating greater severity of problematic gaming and addiction-related symptoms. The scale has shown adequate internal consistency, with Cronbach's alpha values ranging from 0.81 to 0.83. The IGDT-10 is a ten-item self-report instrument assessing the nine DSM-5 criteria for Internet Gaming Disorder. Using the criteria-based scoring procedure, total scores range from 0 to 9, with higher scores indicating that a greater number of diagnostic criteria are met and greater gaming disorder severity. The instrument has demonstrated acceptable internal consistency, with Cronbach's alpha values ranging from 0.62 to 0.75.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Mindfulness in Adolescents
Change in mindfulness levels among adolescents will be assessed using the validated Spanish version of the Child and Adolescent Mindfulness Measure (CAMM). This 10-item self-report instrument uses a five-point Likert response scale and assesses present-moment awareness and responses to internal experiences. Total scores range from 0 to 40, with higher scores indicating greater mindfulness. The Spanish version has shown acceptable internal consistency (Cronbach's α = 0.68); ordinal alpha values range from 0.70 to 0.80.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Psychological Well-Being in Adolescents
Change in psychological well-being among adolescents will be assessed using the shortened Spanish adolescent version of Ryff's Scales of Psychological Well-Being (SPWB). This 6-item self-report instrument evaluates overall psychological well-being across cognitive, emotional, and behavioural dimensions. Total scores range from 6 to 36, with higher scores indicating greater psychological well-being. The Spanish adolescent version has shown adequate internal consistency, with Cronbach's α = 0.78.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Impulsivity in Adolescents
Change in impulsivity traits among adolescents will be assessed using the validated Spanish short version of the Scale of Impulsivity for Children and Adolescents (BUPPS-P-NA). This 20-item self-report instrument measures five dimensions: negative urgency, lack of perseverance, lack of premeditation, sensation seeking, and positive urgency. Each subscale contains four items rated from 1 to 4, giving a score range of 4 to 16. Higher scores indicate greater levels of the corresponding impulsivity trait. Items from the lack of perseverance and lack of premeditation subscales are reverse-scored before calculating their totals. The instrument has shown adequate internal consistency, with Cronbach's α values ranging from 0.61 to 0.77.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Cyberbullying Involvement
Prevalence and change in cyberbullying involvement among adolescents will be assessed using the validated Spanish version of the European Cyberbullying Intervention Project Questionnaire (ECIP-Q). This 22-item self-report instrument includes two 11-item dimensions: cybervictimisation and cyberaggression. Items are rated on a five-point Likert scale from 0 to 4. Scores for each dimension range from 0 to 44, with higher scores indicating greater involvement as a victim or aggressor, respectively. The instrument has shown high reliability, with McDonald's ω = 0.99 and Cronbach's α = 0.96.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Perceived Social Support
Change in perceived social support among adolescents will be assessed using the validated Spanish adolescent version of the Multidimensional Scale of Perceived Social Support (MSPSS). This 12-item self-report instrument measures perceived support from three sources: family, friends, and significant others. Items are rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). Total scores range from 12 to 84, with higher scores indicating greater perceived social support. The Spanish adolescent version has shown excellent internal consistency, with Cronbach's α = 0.88.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Self-Reported Video Game Use Time
Number of hours spent playing video games will be self-reported by adolescents using an ad hoc questionnaire. Participants will report their typical gaming time separately for weekdays and weekends, allowing changes in video game use across these two periods to be assessed.
Time frame: One year and a half, and at follow-up (6 months after study completion)
Mindfulness in Adults
Change in mindfulness levels among adults in the adolescents' immediate environment will be assessed using the validated Spanish version of the 15-item Five Facets of Mindfulness Questionnaire (FFMQ-15). This self-report instrument assesses five dimensions: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Items are rated from 1 ("never or very rarely true") to 5 ("very often or always true"). Total scores range from 15 to 75, with higher scores indicating greater mindfulness. The instrument has shown acceptable internal consistency, with Cronbach's α values ranging from 0.69 to 0.78.
Time frame: One year and a half
Family-Reported Video Game Use
Number of hours adolescents spend playing video games, as reported by their family members or caregivers using an ad hoc questionnaire. Respondents will report the adolescent's typical gaming time separately for weekdays and weekends, allowing changes in gaming duration across these two periods to be assessed.
Time frame: At the start of the intervention, with a maximum duration of 6 months.
Adherence to the Community Component
Level of adherence to the community-based intervention component, assessed through systematic attendance records of participation in community sessions and activities.
Time frame: Throughout the intervention period (an average of 1 year).
Adherence to the Group-Based Mindfulness Program (Adolescents)
Level of adherence to the classroom-based mindfulness and emotional development program, measured by attendance records across scheduled sessions.
Time frame: Throughout the intervention period (an average of 1 year).
Adherence to the Individual Online Program (Adults)
Level of adherence to the individual online mindfulness and emotional regulation program for adults, assessed through automated platform access and activity logs.
Time frame: Throughout the intervention period (an average of 8 months).
Plan to share: No
Ran from Nov 2025 to primary completion in May 2026, 5 months.
Of 14 interventional studies with no phase under Technology Addiction, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's 5 months is above that.
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Fundacin Biomedica Galicia Sur