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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05917977
Other study ID # UGC/FDS21/H01/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2026

Study information

Verified date September 2023
Source Hong Kong College of Technology
Contact Ka Wo Tse, Doctorate
Phone +852 5720 9881
Email nicktse@ctihe.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study examines the efficacy of CMI in reducing adolescent IGD symptoms and enhancing social support given by CSOs among adolescents with high risk of IGD (probable IGD cases screened positive by validated tools). It is hypothesized that the intervention group (with CMI plus IGD education materials for both the clients and his/her selected CSO) would show more improvements in reduction in the severity of IGD, motivation to change maladaptive gaming behaviour, craving on gaming, and social support obtained from CSOs than to the control group (only educational materials for both the client and the CSOs).


Description:

This study adopts a randomized controlled efficacy study with an open-label parallel-group design. The trial will be registered by the WHO's International Clinical Trials Registry Platform once the project is approved. Research participants will be recruited from the primary and secondary schools, and youth social services. After completing the screening process, research participants who are confirmed to fit the inclusion criteria will be randomly assigned to the intervention group with CMI intervention plus IGD education materials to both adolescents with IGD and their CSO or the control group with IGD education materials alone. The present study sets four-time points to track the change in the between-group difference of the primary and secondary outcomes from the baseline (T0) to post-intervention (T1), 3-month follow-up (T2), and 6-month follow-up (T3).


Recruitment information / eligibility

Status Recruiting
Enrollment 172
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria for Adolescents: - Aged between 10-16 - Probable IGD condition screened by the Internet Gaming Disorder Scale-Short-Form (IGDS9-SF) reaching the cut-off value at 21, those at high risk of having IGD but no IGD cases with clinical diagnosis, although the symptoms measured by IGDS9-SF are equivalent to DSM-5 IGD criteria) - Hong Kong ID card holder - Chinese speaking - Student identity - Possessing an electronic mobile device or computer - Willingness to participate in the intervention/control group and complete four surveys (baseline, post-intervention, 3-month follow-up, and 6-month follow-up) - Can nominate a CSO (e.g., parents) [client's autonomy is a critical factor to facilitate motivation posited by the self-determination theory (Ryan & Deci, 2020) (9) to obtain informed consent and parental consent Inclusion Criteria for CSO: - Aged greater than 18 years - Having a close relationship with the adolescent with probable IGD (as rated by participants being generally supportive of the participants) - Being willing to participate in the present study and provide informed consent Exclusion Criteria for Adolescents: - Participants who have psychiatric problems such as psychosis, significant cognitive impairment and/or receiving active and structured psychotherapy about IGD elsewhere will be excluded (Nielsen et al., 2021). Exclusion Criteria for CSO: - Participants who have psychosis, aggressive or suicidal behavior - Having life-threatening medical conditions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Collective Motivational Interviewing plus Education Materials
The participants in the intervention group will receive IGD educational materials as well as four counseling sessions of CMI intervention.
Other:
Control group (Education Materials)
The participants in the control group will receive IGD educational materials.

Locations

Country Name City State
Hong Kong Hong Kong College of Technology Shatin

Sponsors (5)

Lead Sponsor Collaborator
Hong Kong College of Technology Chinese University of Hong Kong, Fudan University, Nottingham Trent University, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (8)

Chou, K. L. (2000). Assessing Chinese adolescents' social support: The multidimensional scale of perceived social support. Personality and Individual Differences, 28(2), 299-307. https://doi.org/bpjrkw

Nielsen P, Christensen M, Henderson C, Liddle HA, Croquette-Krokar M, Favez N, Rigter H. Multidimensional family therapy reduces problematic gaming in adolescents: A randomised controlled trial. J Behav Addict. 2021 Apr 26;10(2):234-243. doi: 10.1556/2006.2021.00022. Print 2021 Jul 15. — View Citation

Qin L, Cheng L, Hu M, Liu Q, Tong J, Hao W, Luo T, Liao Y. Clarification of the Cut-off Score for Nine-Item Internet Gaming Disorder Scale-Short Form (IGDS9-SF) in a Chinese Context. Front Psychiatry. 2020 May 25;11:470. doi: 10.3389/fpsyt.2020.00470. eCollection 2020. — View Citation

Rustin TA, Tate JC. Measuring the stages of change in cigarette smokers. J Subst Abuse Treat. 1993 Mar-Apr;10(2):209-20. doi: 10.1016/0740-5472(93)90046-5. — View Citation

Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020. — View Citation

Savci, M., & Griffiths, M. D. (2019). The development of the Turkish craving for internet gaming scale (CIGS): A validation study. International Journal of Mental Health and Addiction, 1-18.

Siu AMH, Ko FSL, Mak SK. Outcome Evaluation of a Short-Term Hospitalization and Community Support Program for People Who Abuse Ketamine. Front Psychiatry. 2018 Jul 17;9:313. doi: 10.3389/fpsyt.2018.00313. eCollection 2018. Erratum In: Front Psychiatry. 2019 Jan 22;9:746. — View Citation

Zhu S, Zhuang Y, Lee P, Li JC, Wong PWC. Leisure and Problem Gaming Behaviors Among Children and Adolescents During School Closures Caused by COVID-19 in Hong Kong: Quantitative Cross-sectional Survey Study. JMIR Serious Games. 2021 May 7;9(2):e26808. doi: 10.2196/26808. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of IGD The nine-item Internet Gaming Disorder Scale-Short-Form (IGDS9-SF) are used to detect the change in the severity of IGD. It is the first brief standardized psychometric tool of IGD based on the nine DSM-5 IGD criteria. This instrument has been translated into 15 languages and is widely used in research and clinical settings. In addition, a validated Chinese version with satisfactory psychometric properties is available (Qin et al., 2020). The items were rated by using a 5-point Likert scale (1 = Never to 5 = Very often). Change from Baseline (T0) Severity of IGD at posttest (T1: After intervention)
Primary Severity of IGD The nine-item Internet Gaming Disorder Scale-Short-Form (IGDS9-SF) are used to detect the change in the severity of IGD. It is the first brief standardized psychometric tool of IGD based on the nine DSM-5 IGD criteria. This instrument has been translated into 15 languages and is widely used in research and clinical settings. In addition, a validated Chinese version with satisfactory psychometric properties is available (Qin et al., 2020). The items were rated by using a 5-point Likert scale (1 = Never to 5 = Very often). Change from Baseline (T0) Severity of IGD at 3-month follow-up (T2)
Primary Severity of IGD The nine-item Internet Gaming Disorder Scale-Short-Form (IGDS9-SF) are used to detect the change in the severity of IGD. It is the first brief standardized psychometric tool of IGD based on the nine DSM-5 IGD criteria. This instrument has been translated into 15 languages and is widely used in research and clinical settings. In addition, a validated Chinese version with satisfactory psychometric properties is available (Qin et al., 2020). The items were rated by using a 5-point Likert scale (1 = Never to 5 = Very often). Change from Baseline (T0) Severity of IGD at 6-month follow-up (T3)
Secondary Motivation to change maladaptive gaming behaviour Contemplation Ladder for Internet Gaming (CL-LG), which is derived from the Contemplation Ladder measure the motivation to quit smoking (Biener & Abrams, 1991), are employed. Contemplation Ladder for drug use problems is commonly used in clinical settings and research in Hong Kong (Siu et al., 2018). The instrument measures the motivation to abstain from maladaptive gaming behaviors based on a single brief option of 11 rungs and five types of statements. The instrument is rated on a scale from 0 to 10, with each point representing a specific statement showing a corresponding stage of change. The ladder has been used in smoking cessation studies, which displayed strong reliability and validity with strong intercorrelations (Pearson's r = .82 - .98) (Rustin & Tate, 1993). Change from Baseline (T0) Motivation to change maladaptive gaming behaviour at posttest (T1: After intervention)
Secondary Motivation to change maladaptive gaming behaviour Contemplation Ladder for Internet Gaming (CL-LG), which is derived from the Contemplation Ladder measure the motivation to quit smoking (Biener & Abrams, 1991), are employed. Contemplation Ladder for drug use problems is commonly used in clinical settings and research in Hong Kong (Siu et al., 2018). The instrument measures the motivation to abstain from maladaptive gaming behaviors based on a single brief option of 11 rungs and five types of statements. The instrument is rated on a scale from 0 to 10, with each point representing a specific statement showing a corresponding stage of change. The ladder has been used in smoking cessation studies, which displayed strong reliability and validity with strong intercorrelations (Pearson's r = .82 - .98) (Rustin & Tate, 1993). Change from Baseline (T0) Motivation to change maladaptive gaming behaviour at 3-month follow-up (T2)
Secondary Motivation to change maladaptive gaming behaviour Contemplation Ladder for Internet Gaming (CL-LG), which is derived from the Contemplation Ladder measure the motivation to quit smoking (Biener & Abrams, 1991), are employed. Contemplation Ladder for drug use problems is commonly used in clinical settings and research in Hong Kong (Siu et al., 2018). The instrument measures the motivation to abstain from maladaptive gaming behaviors based on a single brief option of 11 rungs and five types of statements. The instrument is rated on a scale from 0 to 10, with each point representing a specific statement showing a corresponding stage of change. The ladder has been used in smoking cessation studies, which displayed strong reliability and validity with strong intercorrelations (Pearson's r = .82 - .98) (Rustin & Tate, 1993). Change from Baseline (T0) Motivation to change maladaptive gaming behaviour at 6-month follow-up (T3)
Secondary Craving for Internet Gaming Craving for Internet Gaming Scale (CIGS) is used to measure respondents' intensity, frequency, duration of their craving, and capability to resist acting on their craving for a particular period of time. It comprises five-item, scoring from 0 to 6 for each item. Respondents with higher scores tend to have higher levels of gaming craving (Cronbach's alpha was .88-.91) (Savci & Griffiths, 2019). Change from Baseline (T0) Craving for Internet Gaming at posttest (T1: After intervention)
Secondary Craving for Internet Gaming Craving for Internet Gaming Scale (CIGS) is used to measure respondents' intensity, frequency, duration of their craving, and capability to resist acting on their craving for a particular period of time. It comprises five-item, scoring from 0 to 6 for each item. Respondents with higher scores tend to have higher levels of gaming craving (Cronbach's alpha was .88-.91) (Savci & Griffiths, 2019). Change from Baseline (T0) Craving for Internet Gaming at 3-month follow-up (T2)
Secondary Craving for Internet Gaming Craving for Internet Gaming Scale (CIGS) is used to measure respondents' intensity, frequency, duration of their craving, and capability to resist acting on their craving for a particular period of time. It comprises five-item, scoring from 0 to 6 for each item. Respondents with higher scores tend to have higher levels of gaming craving (Cronbach's alpha was .88-.91) (Savci & Griffiths, 2019). Change from Baseline (T0) Craving for Internet Gaming at 6-month follow-up (T3)
Secondary Social support from CSO The 4-item significant other subscales of the Multidimensional Scale of Perceived Social Support (MSPSS) will be used. It is a self-reporting instrument designed for assessing the level of perceived social support from significant others. The items are scored on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). The Cantonese version has demonstrated a high internal consistency coefficient with a Cronbach's alpha of .89 (Chou, 2000). Change from Baseline (T0) Social support from CSO at posttest (T1: After intervention)
Secondary Social support from CSO The 4-item significant other subscales of the Multidimensional Scale of Perceived Social Support (MSPSS) will be used. It is a self-reporting instrument designed for assessing the level of perceived social support from significant others. The items are scored on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). The Cantonese version has demonstrated a high internal consistency coefficient with a Cronbach's alpha of .89 (Chou, 2000). Change from Baseline (T0) Social support from CSO at 3-month follow-up (T2)
Secondary Social support from CSO The 4-item significant other subscales of the Multidimensional Scale of Perceived Social Support (MSPSS) will be used. It is a self-reporting instrument designed for assessing the level of perceived social support from significant others. The items are scored on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). The Cantonese version has demonstrated a high internal consistency coefficient with a Cronbach's alpha of .89 (Chou, 2000). Change from Baseline (T0) Social support from CSO at 6-month follow-up (T3)
Secondary Child-Parent Relationship The Child-Parent Relationship Scale (C-PRS). The items are scored on a 5-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree). Change from Baseline (T0) Child-Parent Relationship at posttest (T1: After intervention)
Secondary Child-Parent Relationship The Child-Parent Relationship Scale (C-PRS). The items are scored on a 5-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree). Change from Baseline (T0) Child-Parent Relationship at 3-month follow-up (T2)
Secondary Child-Parent Relationship The Child-Parent Relationship Scale (C-PRS). The items are scored on a 5-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree). Change from Baseline (T0) Child-Parent Relationship at 6-month follow-up (T3)
Secondary Parental Stress The 17-items Parental Stress Scale (PSS). The items are scored on a 6-point Likert scale ranging from 1 (very strongly disagree) to 6 (very strongly agree). Change from Baseline (T0) Parental Stress at posttest (T1: After intervention)
Secondary Parental Stress The 17-items Parental Stress Scale (PSS). The items are scored on a 6-point Likert scale ranging from 1 (very strongly disagree) to 6 (very strongly agree). Change from Baseline (T0) Parental Stress at 3-month follow-up (T2)
Secondary Parental Stress The 17-items Parental Stress Scale (PSS). The items are scored on a 6-point Likert scale ranging from 1 (very strongly disagree) to 6 (very strongly agree). Change from Baseline (T0) Parental Stress at 6-month follow-up (T3)
Secondary Motivation for treatment The 8-item Motivation for Youth's Treatment Scale (MYTS). The items are scored on a 5-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree). Change from Baseline (T0) Motivation for treatment at posttest (T1: After intervention)
Secondary Motivation for treatment The 8-item Motivation for Youth's Treatment Scale (MYTS). The items are scored on a 5-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree). Change from Baseline (T0) Motivation for treatment at 3-month follow-up (T2)
Secondary Motivation for treatment The 8-item Motivation for Youth's Treatment Scale (MYTS). The items are scored on a 5-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree). Change from Baseline (T0) Motivation for treatment at 6-month follow-up (T3)
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