Active — Not RecruitingNot Applicable

Community-Based Intervention to Reduce Problematic Video Game Use in First-Year Secondary School Students: A Cluster Randomised Controlled Trial

Spain492 participantsStarted 2025-11-15

Plain-language summary

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.

Who can participate

Age range

11 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Educational Centres Inclusion Criteria: * Publicly funded * Located in the province of Pontevedra * Provide compulsory secondary education * Agree to participate in the study * Allow implementation of the programme Exclusion Criteria: * Simultaneous participation in another structured programme specifically addressing problematic video game use, gaming disorder, mindfulness or screen use. * Unable to guarantee the minimum conditions required for programme implementation Adolescents Inclusion Criteria: * Enrolled in the first year of compulsory secondary education at a participating centre * Provide signed informed consent * Have sufficient proficiency in the language used for the intervention and questionnaires * Are able to complete the study assessments Exclusion Criteria: * Difficulties that prevent participation in the sessions or completion of the questionnaires and cannot be managed with reasonable support * Signed informed consent is not provided * Consent is withdrawn at any time Adults Inclusion Criteria: * Parent, legal guardian, or caregiver of a participating adolescent and/or an adult involved in the school-based coordinating group * Agree to participate * Provide signed informed consent * Have access to an internet-connected electronic device to complete the online mindfulness programme and questionnaires Exclusion Criteria: * Consent is withdrawn * No access to a suitable internet-connected device

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Problematic Video Game Use and Game Addiction

Timeframe: One year and a half, and at follow-up (6 months after study completion)

Trial details

NCT IDNCT07357792

SponsorFundacin Biomedica Galicia Sur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-10

View on ClinicalTrials.gov More Video Game Addiction trials