NCT07357792

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,668

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

December 12, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

gaming disordervideo game addictionmindfulnesssocial supportcyberbullyingimpulsivitywell-being

Outcome Measures

Primary Outcomes (1)

  • Problematic Video Game Use and Potential Video Game Addiction

    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 Outcomes (8)

  • Mindfulness in Adolescents

    One year and at follow-up (6 months after study completion)

  • Psychological Well-Being in Adolescents

    One year and at follow-up (6 months after study completion)

  • Impulsivity in Adolescents

    One year and at follow-up (6 months after study completion)

  • Cyberbullying Involvement

    One year and at follow-up (6 months after study completion)

  • Perceived Social Support

    One year and at follow-up (6 months after study completion)

  • +3 more secondary outcomes

Other Outcomes (3)

  • Adherence to the Community Component

    Throughout the intervention period (an average of 1 year).

  • Adherence to the Group-Based Mindfulness Program (Adolescents)

    Throughout the intervention period (an average of 1 year).

  • Adherence to the Individual Online Program (Adults)

    Throughout the intervention period (an average of 8 months).

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Community-Based Participatory Leisure InterventionBehavioral: Classroom-Based Mindfulness and Emotional Development Program (Adolescents)Behavioral: Online Mindfulness and Emotional Regulation Program (Adults)

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

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.

Intervention Group

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.

Intervention Group

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Saúde de Rosalía de Castro

Vigo, Pontevedra, 36201, Spain

Location

Related Publications (9)

  • Mettler, J., Mills, D.J., Heath, N.L. (2020). Problematic Gaming and Subjective Well-Being: How Does Mindfulness Play a Role? International Journal of Mental Health and Addiction, 18(3), 720-736.

    BACKGROUND
  • Kim J, Lee S, Lee D, Shim S, Balva D, Choi KH, Chey J, Shin SH, Ahn WY. Psychological treatments for excessive gaming: a systematic review and meta-analysis. Sci Rep. 2022 Nov 28;12(1):20485. doi: 10.1038/s41598-022-24523-9.

    PMID: 36443408BACKGROUND
  • Ji Y, Yin MXC, Zhang AY, Wong DFK. Risk and protective factors of Internet gaming disorder among Chinese people: A meta-analysis. Aust N Z J Psychiatry. 2022 Apr;56(4):332-346. doi: 10.1177/00048674211025703. Epub 2021 Jul 10.

    PMID: 34250835BACKGROUND
  • Király, O., Griffiths, M.D., & Demetrovics, Z. (2015). Internet Gaming Disorder and the DSM-5: Conceptualization, Debates, and Controversies. Current Addiction Reports, 2(3), 254-262.

    BACKGROUND
  • King DL, Delfabbro PH, Billieux J, Potenza MN. Problematic online gaming and the COVID-19 pandemic. J Behav Addict. 2020 Apr 29;9(2):184-186. doi: 10.1556/2006.2020.00016. Print 2020 Jun.

    PMID: 32352927BACKGROUND
  • Andrade-Pérez, B.A., Guadix-García, I.G., Rial-Boubeta, A.R., & Suárez-Lorenzo, F.S. (2021). El impacto de la tecnología en la adolescencia: relaciones, riesgos y oportunidades. UNICEF.

    BACKGROUND
  • Gao YX, Wang JY, Dong GH. The prevalence and possible risk factors of internet gaming disorder among adolescents and young adults: Systematic reviews and meta-analyses. J Psychiatr Res. 2022 Oct;154:35-43. doi: 10.1016/j.jpsychires.2022.06.049. Epub 2022 Jul 19.

    PMID: 35926424BACKGROUND
  • Derevensky JL, Hayman V, Lynette Gilbeau. Behavioral Addictions: Excessive Gambling, Gaming, Internet, and Smartphone Use Among Children and Adolescents. Pediatr Clin North Am. 2019 Dec;66(6):1163-1182. doi: 10.1016/j.pcl.2019.08.008.

    PMID: 31679605BACKGROUND
  • Rial Boubeta, A. R. (2022). Adolescencia, tecnología, salud y convivencia: un estudio integral y proactivo desde los propios adolescentes. Fundación Barrié.

    BACKGROUND

MeSH Terms

Conditions

Technology AddictionCyberbullyingImpulsive Behavior

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorBehaviorBullyingAggressionBehavioral SymptomsHarassment, Non-SexualSocial Behavior

Study Officials

  • Ana M. Clavería Fontán, Primary Care Health Technician

    Servicio Gallego de Salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a community-based, non-blinded, controlled interventional study with parallel groups. Allocation is performed at the classroom level within participating schools. The study uses a longitudinal design with repeated measurements (pre-intervention, post-intervention, and follow-up) to assess the effectiveness of a multi-component intervention implemented under real-world conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

January 22, 2026

Study Start

September 26, 2025

Primary Completion

December 11, 2025

Study Completion

February 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations