NCT06821373

Brief Summary

The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT. Hypothesis: The intervention group will show a greater reduction in rates of IGD and/or SMA at post-treatment and 3-month follow-up than the control group. Design and subjects: A two-armed RCT between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. Screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted. Participants will: Be randomly assigned to online brief intervention or psycho-educational control Complete questionnaires evaluating 1 ) Primary outcomes (IGD, SMA), 2) Secondary outcomes (sedentary lifestyle, mental distress, quality of life, eHealth literacy) and 3) Mediators/mechanisms (autonomy, competence)

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

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

September 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 4, 2025

Last Update Submit

February 9, 2025

Conditions

Keywords

Internet gaming disorderChatbotSocial media addictionStage of changemotivation enhancementLow-intensitySedentary lifestyleAdolescent mental health

Outcome Measures

Primary Outcomes (3)

  • Internet gaming disorder (IGD)

    IGD symptoms are assessed using the Nine-Item Internet Gaming Disorder Scale-Short Form (IGDS9-SF) consists of nine questions that assess IGD symptoms, including preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm. The response options for each item include "yes=1" and "no=0". The overall score of the scale ranges from 0 to 9, with a higher score implying a higher level of IGD symptoms. Participants with score ≥ 5 will be classified as having probable IGD.

    From enrollment to the end of follow-up at 3 months

  • Social media addiction (SMA)

    SMA is defined as excessive use of social media with the addictive symptoms like mood modification, salience, tolerance, withdrawal symptoms, conflict, and relapse. The symptoms of SMA will be measured by the 6-item Bergen Social Media Addiction Scale (BSMAS) based on the six core components of addictive behaviors, including cognitive salience, tolerance, mood modification, difficulty in regulating use, withdrawal, and interference with role performance. The items are rated using a Likert type scale ranging between 1 (very rarely) and 5 (very often). A higher sum score in the BSMAS indicates a greater likelihood of being at risk of developing social media addiction. A cut-off score over 19 indicates probable SMA.

    From enrollment to end of follow-up at 3 months

  • Composite score of IGD and SMA

    Composite outcome of IGD score and SMA score: we define a simple composite as the sum of the two outcomes. Because each outcome measure uses a different scale and has different statistical properties, we will standardize the two variables (i.e., scores of IGD and SMA) first, and then combine the two standardized scores of the outcomes into a composite.

    From enrollment to end of follow-up at 3 months.

Secondary Outcomes (5)

  • Sedentary lifestyle

    From enrollment to end of 3 months follow-up

  • Entertainment screen time

    From enrollment to end of follow-up at 3 months

  • Health-related Quality of life

    From enrollment to end of follow-up at 3 months

  • Mental distress

    From enrollment to end of follow-up at 3 months

  • eHealth literacy

    From enrollment to end of follow-up at 3 months

Other Outcomes (2)

  • Autonomy

    From enrollment to end of follow-up at 3 months

  • Competence (self-efficacy)

    From enrollment to end of follow-up at 3 months

Study Arms (2)

Control

SHAM COMPARATOR

Participants will receive educational but not SoC and MI-based materials about excessive digital use, IGD, and SMA. Such psycho-educational interventions are widely used in behavioral/mental health promotion and have been demonstrated to be effective in increasing knowledge and awareness of behavioral and mental problems. Based on a comprehensive literature review and our previous psycho-educational programs for behavioral/mental health promotion, the research team will design the psycho-educational materials. Themes include definitions, factors, and health consequences of excessive digital use, IGD, and SMA, information on healthy lifestyles, self-regulation skills, and help-seeking resources.

Behavioral: Control

Chatbot

EXPERIMENTAL

The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules.

Behavioral: Chatbot

Interventions

ChatbotBEHAVIORAL

The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules.

Chatbot
ControlBEHAVIORAL

The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules.

Control

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Students at grades 5-6 in primary schools or grades 7-12 in secondary schools,
  • Positive screening results of IGD and/or SMA) based on the validated screening tools
  • Using smartphone or Internet on a daily base, 4) students' and parental consent,
  • Chinese speaking.

You may not qualify if:

  • Current use of any psychotropic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Internet Addiction DisorderSedentary Behavior

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Xue Yang, Doctoral

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Yang, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 12, 2025

Study Start

September 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations