Clinical trial NCT05917977: Collective Motivational Interviewing (CMI) for Adolescents With Internet Gaming Disorder
Official title: A Randomized Controlled Study of Collective Motivational Interviewing (CMI) for Adolescents With Internet Gaming Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Internet Gaming Disorder
Keywords: Motivational interviewing
Family counselling
Effective treatment
Randomized controlled trial
Lead sponsor: Hong Kong College of Technology
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Chinese University of Hong Kong
name: Nottingham Trent University
name: Fudan University
First posted: 2023-06-26
Enrollment: 172
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study adopted a two-armed RCT to examine the efficacy of CMI in improving IGD among adolescents with IGD. The research participants will be randomly assigned to either the intervention group (four-session CMI intervention plus IGD educational materials) or the control group (IGD education materials alone). Block randomization will be executed, of which the block size is 4. Computer-generated randomization allocation codes will be produced and sealed in opaque envelopes by a research associate with no involvement in recruitment. One envelope will be drawn and opened by the project officer.
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Severity of IGD
timeFrame: Change from Baseline (T0) Severity of IGD at posttest (T1: After intervention)
measure: Severity of IGD
timeFrame: Change from Baseline (T0) Severity of IGD at 3-month follow-up (T2)
measure: Severity of IGD
timeFrame: Change from Baseline (T0) Severity of IGD at 6-month follow-up (T3)
Secondary outcomes:
measure: Motivation to change maladaptive gaming behaviour
timeFrame: Change from Baseline (T0) Motivation to change maladaptive gaming behaviour at posttest (T1: After intervention)
measure: Motivation to change maladaptive gaming behaviour
timeFrame: Change from Baseline (T0) Motivation to change maladaptive gaming behaviour at 3-month follow-up (T2)
measure: Motivation to change maladaptive gaming behaviour
timeFrame: Change from Baseline (T0) Motivation to change maladaptive gaming behaviour at 6-month follow-up (T3)
measure: Craving for Internet Gaming
timeFrame: Change from Baseline (T0) Craving for Internet Gaming at posttest (T1: After intervention)
measure: Craving for Internet Gaming
timeFrame: Change from Baseline (T0) Craving for Internet Gaming at 3-month follow-up (T2)
measure: Craving for Internet Gaming
timeFrame: Change from Baseline (T0) Craving for Internet Gaming at 6-month follow-up (T3)
measure: Social support from CSO
timeFrame: Change from Baseline (T0) Social support from CSO at posttest (T1: After intervention)
measure: Social support from CSO
timeFrame: Change from Baseline (T0) Social support from CSO at 3-month follow-up (T2)
measure: Social support from CSO
timeFrame: Change from Baseline (T0) Social support from CSO at 6-month follow-up (T3)
measure: Child-Parent Relationship
timeFrame: Change from Baseline (T0) Child-Parent Relationship at posttest (T1: After intervention)
measure: Child-Parent Relationship
timeFrame: Change from Baseline (T0) Child-Parent Relationship at 3-month follow-up (T2)
measure: Child-Parent Relationship
timeFrame: Change from Baseline (T0) Child-Parent Relationship at 6-month follow-up (T3)
measure: Parental Stress
timeFrame: Change from Baseline (T0) Parental Stress at posttest (T1: After intervention)
measure: Parental Stress
timeFrame: Change from Baseline (T0) Parental Stress at 3-month follow-up (T2)
measure: Parental Stress
timeFrame: Change from Baseline (T0) Parental Stress at 6-month follow-up (T3)
measure: Motivation for treatment
timeFrame: Change from Baseline (T0) Motivation for treatment at posttest (T1: After intervention)
measure: Motivation for treatment
timeFrame: Change from Baseline (T0) Motivation for treatment at 3-month follow-up (T2)
measure: Motivation for treatment
timeFrame: Change from Baseline (T0) Motivation for treatment at 6-month follow-up (T3)
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Hong Kong College of Technology
Study officials:
References:
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.
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.
citation: 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.
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.
citation: 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.
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.
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.
citation: 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