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CTRI Number  CTRI/2024/11/077118 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Intervention for adolescents with problematic video gaming in non-clinical population  
Scientific Title of Study   Effectiveness of Multicomponent Intervention for Adolescents with Problematic Video Gaming  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sterin Joseph 
Designation  Research Scholar 
Affiliation  Christ (Deemed to be University) 
Address  School of Psychological Sciences,Central block,8th Floor Christ (Deemed to be University), Hosur Road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9447583312  
Fax    
Email  sterin.joseph@res.christuniversity.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tony Sam George  
Designation  Dean, School of Psychological Science 
Affiliation  Christ University 
Address  School of Psychological Sciences, Christ (deemed to be)University, Bengaluru -29

Bangalore
KARNATAKA
560029
India 
Phone  9845079289  
Fax    
Email  tony.sam.george@christuniversity.in  
 
Details of Contact Person
Public Query  
Name  Dr Tony Sam George  
Designation  Dean, School of Psychological Science 
Affiliation  Christ University 
Address  School of Psychological Sciences, Christ (deemed to be)University, Bengaluru -29

Bangalore
KARNATAKA
560029
India 
Phone  9845079289  
Fax    
Email  tony.sam.george@christuniversity.in  
 
Source of Monetary or Material Support  
Pallotti Hill Public School, Agastianmuzhi, Mukkam, Kozhikode,Kerala-673602, India  
 
Primary Sponsor  
Name  Sterin Joseph 
Address  School of Psychological Sciences, Department of Psychology Christ (deemed to be)University, Bengaluru -29 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vipin Augusty  Pallotti Hill School  Jubilee Hall ,2nd Floor, Agastiamuzhi, Mukkam, Kozhikode - 673602,Kerala
Kozhikode
KERALA 		 9356393390

vipinthadathil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christ University Research Conduct and Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Behavioural Modification Intervention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Multicomponent Intervention for Adolescents with Problematic Video Gaming  The intervention group will receive the multicomponent intervention and the control group will be waitlisted until the treatment is over. 
Intervention  Multicomponent Intervention for Adolescents with Problematic Video Gaming  The intervention provides psychological care in school settings to educate, prevent and manage adolescents with problematic gaming usage. The study tries to find out the impact of video games on self-esteem, social interaction anxiety and well-being of adolescents. It is an area to be researched and findings are to be implemented to address the gap. It will help mental health professionals and teachers to contribute effectively to the well-being of adolescents who have problematic video game usage. 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  The adolescents who are studying in 7th to 9th grades who have problematic video game usage .
The adolescents who are willing to participate in research. 
 
ExclusionCriteria 
Details  Subjects diagnosed with any mental illness.
Subjects who are below grade six and above grade ten are excluded
Subjects who are not interested in video games 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The expected outcome is that, there would be significant difference in the intervention group, and the study will help in developing a standardized coping skills intervention for adolescents with problematic gaming behaviour.  There are two time points , at the baseline level and after three weeks interval 
 
Secondary Outcome  
Outcome  TimePoints 
In the post assessment after a month there will be decline in the usage of problematic video games and improvement in self esteem, wellbeing and decrease in social interaction anxiety.  one month interval 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   30/11/2024 
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="1"
Months="0"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  upon request

  6. For how long will this data be available start date provided 01-10-2024 and end date provided 01-10-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Consecutive sampling will be employed to identify the student’s population from Pallottine hill public school in Kozhikode , Kerala. Once the students are selected, permission for doing the research will be obtained from the school authorities, from the parents and assent from students whose parents have given the consent. The researcher picks up the subjects who are meeting the inclusion criteria. The students from 7 th to 9 th graders will be screened for problematic video game usage. A screening test will be conducted among the students for problematic video game usage. Once the screening is done, those who meet the exclusion criteria will be given preventive psycho education or a leaflet.

The selected students will be then divided into the intervention group and control group using random sampling. Once the intervention group and the control group are formed, a baseline assessment will be conducted among both the groups. Post which, the intervention group will be given a combination of psychotherapies while the active control group will be divided into two. Here, one of the groups will be given  psychological intervention while the other group will be waitlisted . This is to prove the efficacy of the multi component model. On completion of the intervention, a post- assessment will be conducted both in the intervention group and in the control groups. 

 
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