NCT07363850

Brief Summary

This is a randomized, parallel-group, two-arm study design registered with the Chinese Clinical Trial Registry. The study divides participants into an intervention group and a control group in the same ratio. The participants in the intervention group will receive a series of game-based activities and treatment. Firstly, we will distribute the recruitment advertisements for this intervention program in the school, including the project introduction, registration code, and contact details. Secondly, if students are interested in this project, they need to screen the code, and completely fill in personal information, and the screening questionnaire. Thirdly, students reaching the inclusion criteria and their parents will be invited to participate in a project briefing session and obtain their informed consent. Lastly, three times assessments in the whole process will be conducted, preintervention(T0), post-intervention(T1), and at a three-month(T3) follow-up. Importantly, participants can quit the project at any time during the whole process.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
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 Progress48%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 23, 2026

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

November 19, 2025

Last Update Submit

January 14, 2026

Conditions

Keywords

Gaming Disorder

Outcome Measures

Primary Outcomes (1)

  • the severity of gaming disorder

    Description: Measured by Gaming Disorder Screening Scale

    baseline, two months after intervention

Secondary Outcomes (5)

  • average daily gaming hours

    baseline, two months after intervention

  • frequency of gaming sessions

    baseline, two months after intervention

  • anxiety severity

    baseline, two months after intervention

  • depression severity

    baseline, two months after intervention

  • self-esteem

    baseline, two months after intervention

Study Arms (2)

intervention group

EXPERIMENTAL
Behavioral: group gaming interventions

control group

NO INTERVENTION

Interventions

Each intervention is once a week for 90 minutes. A total of 10 sessions are set up, divided into the beginning stage (the 1st and the 2nd sessions), the middle stage (the 3rd to 8th), and the end stage (the 9th and 10th sessions). At this stage, the leader distributes point cards and wish lists to each member and explains the scoring rules, updating scores at the end of each activity. The point system combines group and individual scoring for cumulative totals. Each member may list desired prizes on their wish list, which will be redeemed for rewards based on their point total when the group concludes. The main aim of the middle stage is to knowledge game types, learn game reward mechanisms, the concept of IGD and influencing factors, and how to play healthily. In the end stage, each subgroup needs to show their complete game design, including the game name, game character, game rule, and reward mechanism, and all participants will make a summary of the whole process and say farewell

intervention group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (1) Clinical diagnosis of hazardous gaming defined in the ICD-11 (2) Fully comprehending the research's purpose and procedures and signing the informed consent

You may not qualify if:

  • (1)Serious physical illness or intellectual disability (2) Clinical diagnosis of gaming disorder (3) Not completing all the interventions or assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

January 23, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 23, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations