NCT06811571

Brief Summary

The investigators established a mobile-based early intervention on adolescent hazardous gaming and verified its effectiveness.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 6, 2025

Status Verified

June 1, 2024

Enrollment Period

3.5 years

First QC Date

July 16, 2024

Last Update Submit

February 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the severity of gaming disorder

    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)

the intervention group

EXPERIMENTAL

The mobile-based early intervention on adolescent hazardous gaming was implemented through WeChat, a popular multipurpose social-networking app in China. The mini-program regularly delivered contents to the users' WeChat homepage, reminding them to timely complete the interventions. The completion status of the users was collected and sent to the backend intervention provider. The intervention group received the one-month intervention.

Behavioral: the mobile-based early intervention

the control group

NO INTERVENTION

The control group did not receive the intervention. Both two groups accepted the assessments at baseline and two months after the intervention.

Interventions

The theoretical framework of the intervention was based on Cognitive Behavior Therapy (CBT). We designed three modules, which were the Gaming behavior management, the Gaming cognition establishment and the Early intervention on risk and protective factors. The interventions included self-monitoring questionnaires, scientific popular articles, and online lectures.

the 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, China

RECRUITING

Study Officials

  • Na Zhong, MD

    Shanghai Mental Health Center

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 16, 2024

First Posted

February 6, 2025

Study Start

July 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 6, 2025

Record last verified: 2024-06

Locations