Community-based Study With 1st-year Secondary Students (n=1104) and Their Environment. It Evaluates a Complex Intervention (Community Actions, Classroom-based Mindfulness for Adolescents, and Online Mindfulness for Adults) to Reduce Problematic Video Game Use and Improve Well-being. (AQJ)

January 13, 2026 updated by: Fundacin Biomedica Galicia Sur

Effectiveness of a Randomized Complex Intervention With Adolescents and Their Environment to Assess the Reduction of Problematic Video Game Use and Potential Video Game Addiction by Promoting Shared Active Leisure and Personal Development

The goal of this observational, community-based study is to evaluate the effectiveness of a complex intervention designed to reduce problematic video game use and the risk of video game addiction in adolescents, while promoting active, shared leisure activities and personal and emotional development.

The study involves students in the first year of secondary education (approximately 12-13 years old) from multiple schools in Pontevedra (Galicia, Spain), as well as adults from their close environment, including family members, teachers, health professionals, and community representatives. Schools are assigned either to an intervention group or to a control group with similar sociodemographic characteristics.

The study is based on a systems and community perspective, assuming that adolescents' video game use is influenced by individual factors (such as impulsivity and emotional regulation), as well as by family, school, and community contexts and the availability of appealing leisure alternatives. For this reason, the intervention consists of three coordinated components that are implemented over time in the intervention schools.

The main questions the study aims to answer are: (a) Can a complex intervention combining community participation and mindfulness-based training reduce problematic video game use and the risk of video game addiction in adolescents?; (b) Does classroom-based mindfulness training improve adolescents' mindfulness, emotional well-being, and self-regulation?; (c) Does mindfulness training for adults improve their own well-being and their ability to support adolescents in adopting healthier leisure habits?; and (d) Can a participatory, community-based approach increase adolescents' awareness and use of active, screen-free leisure alternatives?

Researchers will compare adolescents from intervention schools with adolescents from control schools, where no intervention is implemented and only data are collected. Outcomes will be measured at three time points: before the intervention, after the intervention, and at follow-up, in order to assess changes over time and the sustainability of effects.

Participants will:

  • Complete questionnaires at different time points assessing video game use, possible video game addiction, mindfulness, psychological well-being, impulsivity, cyberbullying, social support, and online experiences.
  • Take part in a community-based component in which adolescents actively participate in identifying, designing, and promoting leisure activities without screens in their local environment. This process includes the creation of a school-based community group composed of adolescents, teachers, health professionals, family representatives, and community members. Adolescents are involved in participatory activities to map community resources and co-design attractive leisure options, which are later implemented and shared with families and the wider community.
  • Participate in a group-based mindfulness and emotional development program delivered in the classroom during school hours. This program consists of structured sessions based on established mindfulness protocols and is designed to help adolescents develop attention skills, emotional awareness, stress management, and self-regulation.
  • Access an individual, online mindfulness and emotional regulation program (adults only), which combines mindfulness practices and cognitive-behavioral strategies. This self-guided program is completed over several weeks and aims to improve adults' well-being and provide tools to better support adolescents.

By integrating community action, school-based intervention, and adult involvement, this study seeks to evaluate a comprehensive and sustainable approach to preventing problematic video game use and promoting healthier lifestyles during adolescence

Study Overview

Detailed Description

Video games are a common form of leisure among adolescents and can have positive effects when used in moderation. However, excessive or problematic use during adolescence has been associated with negative consequences for physical health, emotional well-being, academic performance, and social relationships. In recent years, concerns have increased regarding the risk of problematic video game use and potential video game addiction, particularly in relation to online gaming, prolonged screen time, and difficulties in emotional self-regulation.

Adolescence is a critical developmental period in which habits related to leisure, coping strategies, and emotional regulation are established. Research suggests that problematic video game use does not depend solely on individual behavior, but is influenced by a combination of personal, family, school, and community factors.

The widespread use of video games among adolescents has increased substantially in recent years, making digital gaming one of the main forms of leisure during this developmental stage. While video games can offer entertainment and social interaction, research has shown that excessive or poorly regulated use may be associated with sedentary behavior, sleep disturbances, emotional difficulties, academic problems, and impaired social relationships. In response to these concerns, problematic video game use has been increasingly examined as a public health and mental health issue in adolescence.

The present study is grounded in current scientific evidence indicating that problematic video game use is influenced by multiple interacting factors. These include individual characteristics such as impulsivity, emotional regulation, and stress, as well as contextual factors related to family functioning, school environment, community resources, and the design features of contemporary video games. The study also draws on evidence supporting mindfulness-based approaches as promising tools for improving self-control, emotional awareness, and well-being in adolescents and adults.

The study follows a longitudinal, controlled design with an intervention group and a control group. Participating schools are located in different basic health zones in Pontevedra (Galicia, Spain), representing urban, semi-urban, rural, and coastal contexts. Schools in the intervention and control groups are selected to ensure comparable sociodemographic characteristics.

Allocation is performed at the classroom level, and blinding of participants is not feasible due to the nature of the intervention. However, blinding is applied during data analysis. The study is embedded within the official school planning framework, facilitating institutional support and high participation rates.

The planned sample includes approximately 1,104 adolescents, with 552 students in the intervention group and 552 in the control group. Sample size calculations are based on detecting a 35% reduction in problematic video game use and potential video game addiction, assuming an initial prevalence of approximately 18%. Calculations were performed using standard epidemiological software.

In addition to adolescents, the study includes adults from the adolescents' environment, such as family members, teachers, health professionals, and community representatives, who participate in specific components of the intervention.

The intervention is structured around three coordinated components: a community-based component, a group-based component for adolescents, and an individual component for adults. These components are implemented sequentially and are designed to reinforce each other.

The community-based component aims to promote active, shared, and screen-free leisure activities within the adolescents' local environment. A central element is the creation of a school-based community group composed of adolescents, teachers, health professionals, family representatives, and community members.

This group is trained in participatory action research methodologies, enabling adolescents to actively identify community assets, barriers, and opportunities related to leisure activities. Adolescents participate in mapping local resources, prioritizing feasible and attractive alternatives to video gaming, and co-designing leisure activities adapted to their context.

The selected activities are implemented through organized community events and leisure sessions, which may include physical, recreational, or volunteer activities. Dissemination activities are conducted to share experiences and outcomes with families, schools, health services, and the broader community. This component emphasizes adolescent leadership, shared decision-making, and sustainability.

The group-based component consists of a classroom-based mindfulness and emotional development program delivered to adolescents in intervention schools. The program is based on internationally recognized mindfulness protocols and is adapted to the educational context and developmental stage of early adolescence.

The program is delivered through structured sessions during school hours, focusing on the development of attention, emotional awareness, stress management, and self-regulation. Sessions combine experiential practices, reflective activities, and age-appropriate discussions. No minimum number of participants is required, and adaptations are made to ensure accessibility for students with special educational needs.

This component is designed to address individual factors associated with problematic video game use, such as impulsivity and emotional dysregulation, while complementing the community-based activities.

The individual component targets adults from the adolescents' environment, including family members and members of the community group. It consists of an online, self-guided program combining mindfulness practices and cognitive-behavioral strategies.

The program is delivered through digital platforms and completed over several weeks. It includes structured modules with guided practices, psychoeducational content, and exercises aimed at improving emotional regulation, stress management, and well-being. Participation is voluntary and requires informed consent.

This component is intended to strengthen the supportive role of adults and to promote consistency between adolescents' environments, reinforcing healthy leisure habits and emotional skills.

Data are collected at three time points: baseline (pre-intervention), post-intervention, and follow-up. Validated instruments are used to assess problematic video game use, potential video game addiction, mindfulness, psychological well-being, impulsivity, cyberbullying, social support, and online experiences. Adult participants complete measures related to mindfulness.

Adherence to each intervention component is systematically recorded using attendance logs and digital access records, allowing assessment of engagement and dose-response relationships.

Data are managed using a secure electronic data capture system with pseudonymization and separation of identifying information. This ensures compliance with data protection regulations and supports data integrity.

Statistical analyses are conducted using multilevel mixed-effects models to account for the hierarchical structure of the data (students nested within classrooms and schools) and repeated measurements over time. Analyses compare changes between intervention and control groups while adjusting for relevant covariates such as age, sex, adherence, and contextual factors.

Predefined criteria for intervention success are established based on relative improvements in primary and secondary outcomes, informed by the absence of closely comparable prior interventions.

The study complies with ethical principles for research involving minors, including informed consent procedures and special protections for confidentiality and inclusion. Activities are adapted to ensure accessibility for participants with special educational needs.

Dissemination is integrated throughout the study, with structured activities aimed at families, schools, health services, and the community. Study data are prepared following FAIR principles to support transparency and future research.

Study Type

Interventional

Enrollment (Estimated)

1668

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pontevedra
      • Vigo, Pontevedra, Spain, 36201
        • Centro de Saúde de Rosalía de Castro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • FOR ADOLESCENTS:
  • Age between 11 and 15 years at the time of enrollment.
  • Enrollment in the first year of secondary education in a participating school.
  • Attendance in a classroom assigned to either the intervention or control group.
  • Provision of written informed consent by a parent or legal guardian.
  • Provision of assent by the adolescent, when applicable according to age and regulations (14 years old).
  • FOR ADULTS:
  • Being a parent, legal guardian, teacher, health professional, or community member linked to an adolescent in the intervention group.
  • Willingness to participate in the adult component of the study.
  • Provision of written informed consent.

Exclusion Criteria:

  • FOR ADOLESCENTS:
  • Age below 11 years or above 15 years at the time of enrollment.
  • Lack of written informed consent from a parent or legal guardian.
  • Refusal or inability of the adolescent to provide assent, when applicable.
  • Inability to complete the study questionnaires due to language or comprehension barriers that cannot be reasonably accommodated.
  • FOR ADULTS:
  • Lack of written informed consent.
  • Inability to access or use the digital platform required for the online intervention.
  • Inability to complete study questionnaires due to language or comprehension barriers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in this arm include adolescents enrolled in the first year of secondary education from schools assigned to the intervention group, as well as adults from their close environment. Adolescents receive a complex, multi-component intervention consisting of a community-based component promoting active, shared, and screen-free leisure, and a classroom-based mindfulness and emotional development program. Adults from the adolescents' environment (family members and selected community, educational, and health professionals) participate in an individual, online mindfulness and emotional regulation program. All components are implemented in addition to usual school activities.
This intervention consists of a community-based component designed to promote active, shared, and screen-free leisure among adolescents. It is implemented through the creation of a school-based community group composed of adolescents, teachers, health professionals, family representatives, and community members. Adolescents actively participate in identifying community leisure resources, co-designing leisure activities, and implementing and disseminating these activities within their local environment using participatory action research methodologies.
This intervention is a structured, classroom-based mindfulness and emotional development program delivered to adolescents during school hours. The program is based on established mindfulness protocols and consists of multiple sessions aimed at improving attention, emotional awareness, stress management, and self-regulation. Sessions combine experiential mindfulness practices, reflective activities, and group discussions adapted to early adolescence.
This intervention is an individual, self-guided online program for adults from the adolescents' environment, including family members and selected educational, health, and community professionals. The program combines mindfulness practices and cognitive-behavioral strategies to improve emotional regulation, stress management, and well-being, and to strengthen adults' capacity to support adolescents in developing healthy leisure habits.
No Intervention: Control Group
Participants in this arm include adolescents enrolled in the first year of secondary education from schools assigned to the control group. These participants do not receive any of the intervention components and continue with usual school activities. They participate only in data collection at the predefined assessment time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problematic Video Game Use and Potential Video Game Addiction
Time Frame: One year and at follow-up (6 months after study completion)
Change in problematic video game use and potential video game addiction among adolescents, assessed using validated self-report instruments. Outcomes are measured through the Game Addiction Scale for Adolescents and the Ten-Item Internet Gaming Disorder Test. The minimum score of the Game Addiction Scale for Adolescents is 7 and the maximum score is 35; higher scores indicate greater severity of problematic use or addiction-related symptoms. The minimum score of the Ten-Item Internet Gaming Disorder Test is 0 and the maximum score is 10; higher scores indicate greater serverity of problematic use or addiction-related symptoms.
One year and at follow-up (6 months after study completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness in Adolescents
Time Frame: One year and at follow-up (6 months after study completion)
Change in mindfulness levels among adolescents, assessed using the Child and Adolescent Mindfulness Measure. The scale evaluates attention to the present moment and acceptance of internal experiences. The minimum score is 5 and the maximum 25; higher scores indicate higher and better levels of mindfulness.
One year and at follow-up (6 months after study completion)
Psychological Well-Being in Adolescents
Time Frame: One year and at follow-up (6 months after study completion)
Change in psychological well-being among adolescents, assessed using the Psychological Well-Being Scale for Children and Adolescents, which measures multiple dimensions of well-being. The minimum score is 6 and the maximum is 36; higher scores indicate higher and better levels of mindfulness.
One year and at follow-up (6 months after study completion)
Impulsivity in Adolescents
Time Frame: One year and at follow-up (6 months after study completion)
Change in impulsivity traits among adolescents, assessed using the Scale of Impulsivity for Children and Adolescents. This scale consists of five subscales that are scored individually using Likert-type responses ranging from 1 to 4. The minimum score for the "Negative Urgency," "Sensation Seeking," and "Positive Urgency" subscales is 4 and the maximum is 16; higher scores indicate greater impulsivity. The remaining two subscales have the same minimum and maximum scores but are composed entirely of reverse-scored items; higher scores indicate greater lack of perseverance and lack of premeditation.
One year and at follow-up (6 months after study completion)
Cyberbullying Involvement
Time Frame: One year and at follow-up (6 months after study completion)
Prevalence and change in involvement in cyberbullying behaviors among adolescents, assessed using the Spanish version of the European Cyberbullying Intervention Project Questionnaire, which consists of 22 Likert-type items with response options scored from 0 to 4. It comprises two dimensions: cybervictimization and cyberaggression. The minimum score for each dimension is 11 and the maximum is 44; higher scores indicate greater involvement in the cyberbullying phenomenon, either as a victim or as a perpetrator.
One year and at follow-up (6 months after study completion)
Perceived Social Support
Time Frame: One year and at follow-up (6 months after study completion)
Change in perceived social support among adolescents, assessed using the Multidimensional Scale of Perceived Social Support, which consists of 12 items measuring perceived adequacy of social support from three sources: family members, friends, and significant others. These 12 items are rated on a 7-point Likert-type scale ranging from 1 to strongly agree 7. The minimum score is 12 and the maximum score is 84. The total score corresponds to the sum of the scores for each item, with higher or lower scores indicating greater or lesser perceived social support, respectively.
One year and at follow-up (6 months after study completion)
Self-Reported Video Game Use Time
Time Frame: One year and at follow-up (6 months after study completion)
Change in the number of hours spent playing video games, self-reported by adolescents using an ad hoc questionnaire.
One year and at follow-up (6 months after study completion)
Mindfulness in Adults
Time Frame: One year and at follow-up (6 months after study completion)
Change in mindfulness levels among adults from the adolescents' environment, assessed using the Five Facets of Mindfulness Questionnaire. Consists of 15 Likert-type items with five response options ([1] "Never or very rarely true" to [5] "Always or almost always true") and assesses five dimensions of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. The minimum score is 15 and the maximum score is 75; higher scores indicate higher and greater levels of mindfulness.
One year and at follow-up (6 months after study completion)
Family-Reported Video Game Use
Time Frame: At the start of the intervention, with a maximum duration of 6 months.
Change in the number of hours spent playing video games as reported by family members of adolescents in the intervention group, collected using an ad hoc questionnaire.
At the start of the intervention, with a maximum duration of 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the Community Component
Time Frame: Throughout the intervention period (an average of 1 year).
Level of adherence to the community-based intervention component, assessed through systematic attendance records of participation in community sessions and activities.
Throughout the intervention period (an average of 1 year).
Adherence to the Group-Based Mindfulness Program (Adolescents)
Time Frame: Throughout the intervention period (an average of 1 year).
Level of adherence to the classroom-based mindfulness and emotional development program, measured by attendance records across scheduled sessions.
Throughout the intervention period (an average of 1 year).
Adherence to the Individual Online Program (Adults)
Time Frame: Throughout the intervention period (an average of 8 months).
Level of adherence to the individual online mindfulness and emotional regulation program for adults, assessed through automated platform access and activity logs.
Throughout the intervention period (an average of 8 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ana M. Clavería Fontán, Primary Care Health Technician, Servicio Gallego de Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2025

Primary Completion (Actual)

December 11, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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