NCT07357792

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
492

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2025Apr 2027

Study Start

First participant enrolled

November 15, 2025

Completed
27 days 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

December 12, 2025

Last Update Submit

July 16, 2026

Conditions

Keywords

gaming disordervideo game addictionmindfulnesssocial supportcyberbullyingimpulsivitywell-being

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (8)

  • Mindfulness in Adolescents

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

  • Psychological Well-Being in Adolescents

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

  • Impulsivity in Adolescents

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

  • Cyberbullying Involvement

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

  • Perceived Social Support

    One year and a half, 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 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 ComponentBehavioral: Adolescent Mindfulness ComponentBehavioral: Adult Mindfulness Component

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

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.

Intervention Group

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Publicly funded
  • Located in the province of Pontevedra
  • Provide compulsory secondary education
  • Agree to participate in the study
  • Allow implementation of the programme

You may not qualify if:

  • 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
  • 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
  • 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
  • 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
  • +2 more criteria

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, two-arm cluster randomised controlled trial with parallel groups. Allocation is performed at the educational-centre level, with participating schools randomly assigned to either the intervention group or the control group. The study uses a longitudinal design with repeated assessments at baseline, post-intervention, and 6-month follow-up to evaluate the effectiveness of a multicomponent intervention implemented under real-world school and community conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

January 22, 2026

Study Start

November 15, 2025

Primary Completion

May 10, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations