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CTRI Number  CTRI/2024/12/077885 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral
Other (Specify) [Occupational Therapy]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Intervention for Problematic Gaming in adolescents  
Scientific Title of Study   Effectiveness of school-based intervention for problematic gaming among adolescents: A cluster randomized controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Deena Dimple Dsouza 
Designation  Assistant Professor  
Affiliation  Manipal college of Health Professions, Manipal Academy of Higher Education 
Address  Dept of occupational therapy Manipal College of Health Professions, Manipal academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9663203862  
Fax    
Email  deena.dimple@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr RAVINDRA NEELAKANTHAPPA MUNOLI 
Designation  Additional Professor  
Affiliation  Dept of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Manipal  
Address  Dept of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9972028881  
Fax    
Email  ravindra.nm@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Deena Dimple Dsouza 
Designation  Assistant Professor  
Affiliation  Manipal college of Health Professions, Manipal Academy of Higher Education 
Address  Dept of occupational therapy Manipal College of Health Professions, Manipal academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9663203862  
Fax    
Email  deena.dimple@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, MAHE Manipal Karnataka 576104 
 
Primary Sponsor  
Name  Deena Dimple Dsouza 
Address  Department of Occupational Therapy MCHP, MAHE Manipal, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Caroline   Green Park school   Green Park Central School Hiriadka, Udupi 576113
Udupi
KARNATAKA 		 9538595837

gpcs.1992@gmail.com 
Sandhya Karnad  Shri Anantheshwara High School  near Sri Krishna temple, Maruthi Veethika, Udupi, Karnataka 576101
Udupi
KARNATAKA 		 9663203862

sandhya.karnad@gmail.com 
Anita P Raj  Vidyodaya Public school   Vadiraja Road, Udupi 576101
Udupi
KARNATAKA 		 0820-2522121

vpsudupi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
NOC of Greenpark  No Objection Certificate 
NOC of Shri Anantheshwara High School  No Objection Certificate 
NOC of Vidyodaya  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  At Risk for Gaming Disorder 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Guidance Program for the family  One session in the first week on knowledge and awareness. Written guide will be provided  
Intervention  School Based Prevention Program  Intervention will include self-awareness, Life modification, strategic planning, Behavioural practice, and Relapse Prevention One session per week of 60 minutes for 6 weeks; sessions will include activities, discussions, homework assignments.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  English Speaking
English Medium
AICA-S score of 6.5 and above 
 
ExclusionCriteria 
Details  Staying in hostel
Kannada Medium 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Controlled Gaming   Week 1
week 6
Follow up 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Self-Regulation  Week 1
week 6
Follow up 3 months 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="11"
Days="18" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

To assess the effectiveness of school-based intervention for problematic gaming among adolescents.

The following process will be followed 

Phase 1

•To estimate the prevalence of problematic gaming among adolescents

Study design: Cross-sectional study
Study Site: Schools in Udupi Block, Karnataka, India
Study participants: The study participants will be recruited from schools in Udupi Block studying in 8th and 9th Grade in English Medium Higher Secondary Schools.

•To explore the experience and perceptions of gaming among stakeholders

•Study design: Qualitative design
Study population:
This phase involves focus group discussions and In-depth interviews with stakeholders
Focus group discussion (FGD)– Adolescents
FGD–Professionals (occupational therapists, clinical psychologists, psychiatrists, psychiatry social workers, and teachers)
In-depth interview - Family members of adolescents

Phase 2
•To develop a school-based intervention to prevent problematic gaming among adolescents.

Development of school-based intervention -based on literature review and from the findings of Phase I- Content and face validity be done with five subject experts and Pilot Test -Pre-post design
•Feedback concerning the content/activities will be taken at the end of each session from participants
•Based on the feedback, necessary changes will be incorporated into the final module

•To assess the effectiveness of the school-based intervention in preventing problematic gaming among adolescents.


For baseline data collection, demographic details (age, education, gender, residence status, location) and other information on gaming (gaming genre, time spent per day, weekends spent time, reasons for playing–leisure, boredom, mood modification, and others), general health status, other leisure activities, sleep pattern, will be collected. The study will have six weeks of interventions (one face-to-face session per week), and each session will last 45 minutes to 60 minutes per week. The participant’s group of 6 to 12 will be included in a single session and followed up for six sessions. The primary and secondary outcomes are measured constantly in week 1 (T 0- baseline) and week 6 T 1 post-intervention and Follow-up T 2 three months. The family members will be given a parental guide in week 1. Parental feedback will be taken at the end of the session.
Control group: The control group will receive one session of the awareness program and parental guide in week 1, and in weeks one and six, AICA-S will be administered.
Quantitative Data Analysis: Demographic details will be descriptively analysed. The primary and secondary outcomes will be analysed using an independent t-test. 

 
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