| CTRI Number |
CTRI/2024/12/077885 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2026 |
| 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| 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 |
| Mr Vinayak Kini |
Indrali English Medium High School |
Class of 8 grade and 9th grade Near Railway Bridge, Main Road, Kunjibettu, Udupi, Karnataka - 576102
Udupi
KARNATAKA |
8762688587
indraliemh@gmail.com |
| Sandhya Karnad |
Shri Anantheshwara High School |
near Sri Krishna temple, Maruthi Veethika, Udupi, Karnataka 576101
Udupi
KARNATAKA |
9663203862
sandhya.karnad@gmail.com |
| Ms Puspa Tauro |
St Francis Xavier English Medium School |
Class of 8th Grade and Class of 9th grade
Melpete
Udyavara Udupi Karnataka 574118
Udupi
KARNATAKA |
9845750763
stfransxavieres2004@gmail.com |
| Anita P Raj |
Vidyodaya Public school |
Vadiraja Road, Udupi
576101
Udupi
KARNATAKA |
0820-2522121
vpsudupi@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Indrali English Medium High School |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| No of St Francis |
No Objection Certificate |
| 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
|
|
|
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.
|