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CTRI Number  CTRI/2025/04/085423 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Leveling Up Young Minds: How a therapeutic game promotes Mental Wellbeing in teens 
Scientific Title of Study   Effectiveness of Magis - A Magical Adventure, a Therapeutic Mobile Game in enhancing Psychological Flexibility & Subjective, Academic & Behavioral wellbeing in Early Adolescents: A Quasi-Experimental Active Waitlist Controlled Study  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  HISHEY LAMU BHUTIA 
Designation  Ph D Scholar 
Affiliation  Sikkim Manipal Univeristy 
Address  Department of Pediatrics, Level 2, Room No. 4, Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal Univeristy 5th Mile Tadong East Sikkim

East
SIKKIM
737102
India 
Phone  6294310280  
Fax    
Email  hisheykaleon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Pradhan 
Designation  Professor and Head 
Affiliation  Sikkim Manipal University 
Address  Dept. of Pediatrics Sikkim Mnaipal Institute of Medical Sciences 5th Mile Tadong Gangtok

East
SIKKIM
737101
India 
Phone  890095399  
Fax    
Email  ashish.p@smims.smu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Harshavardhan Sampath 
Designation  Associate Professor 
Affiliation  Sikkim Manipal University 
Address  Dept. of Psychiatry, Sikkim Mnaipal Institute of Medical Sciences, 5th Mile Tadong, Gangtok

East
SIKKIM
737101
India 
Phone  9894967703  
Fax    
Email  harshavardhan.s@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Department of Pediatrics, Level 2, Room No.4, Sikkim Manipal Institute of Medical Sciences, 5th Mile Tadong, Gangtok, East Sikkim, Pin code 737102 India 
 
Primary Sponsor  
Name  Hishey Lamu Bhutia 
Address  Department of Pediatrics, 2nd Level, Room No. 4,Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, 5th Mile Tadong, Gangtok, East Sikkim, Pin Code 737102 India 
Type of Sponsor  Private medical college 
 
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 
Dr Ashish Pradhan  English medium Schools of Sikkim   Department of Pediatrics, Sikkim Manipal Institute of Medical Sciences, Level 2,Room Number 4, Sikkim Manipal University, 5th Mile Tadong, Gangtok, Sikkim, India
East
SIKKIM 		 9800959399

ashish.p@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adolescents studying in schools without any gross mental health, hearing or any other problems 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Waitlist Control Group  The same intervnetion.i.e, Magis, will be given to this control group but after completion of intervnetion in experimental group followed by analysis of the effect of intervention between intervention and control group 
Intervention  Magis-A Magical Adventure, an ACT based therapeutic mobile game  Magis is an ACT-based therapeutic mobile game designed to enhance psychological flexibility and well-being in early adolescents. The game integrates acceptance and value-based approaches to help children process difficult thoughts and emotions, identify personal values, and take values-based actions. The intervention will be administered through 6 sessions including introduction, 4 sessions of gameplay followed by a closing session. Each session will be carried out across 6 weeks, one hour each. Preassessment and post assessments will be done to assess changes in the outcome variables. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Early adolescents aged 12 to 13 years studying in English medium schools of Sikkim 
 
ExclusionCriteria 
Details  Students who have already played Magis - A Magical Adventure, students aged less than 12 & more than 13, Non-assent by student, Non-consent by parents & Gross visual, hearing, and speech impairment that can interfere with participation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Psychological Flexibility (self rated and parent rated)
 		 immediately and one month post intervention

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Academic wellbeing
2. Behavioral wellbeing
3. Subjective wellbeing 		 immediately and one month post intervention 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 2 
Date of First Enrollment (India)   01/07/2025 
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="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 - NO
Brief Summary   The adolescent mental health is a growing concern with 13% of the population (WHO Factsheet 2021) accounting for psychological problems in this age group despite having several mental health initiatives. Psychological flexibility has emerged as a pivotal ingredient in psychological health as it captures the dynamic and situation-specific skills that are necessary in facing the day-to-day challenges of life. An individual with greater psychological flexibility will demonstrate healthier ways of coping with the changes and challenges of daily lives. Flexibly dealing with daily stressors prevent psychological distress that eventually prevents escalation of these stressful reactions to psychological illnesses. The study is thus aimed at enhancing psychological flexibility of adolescents at their formative age i.e. early adolescence that is strategic time for any habit forming interventions. If they are equipped with basic skills and knowledge to deal with life situations flexibly, the development of mental issues later in life can be significantly averted. In addition, gamification of interventions are of specific relevance in this age group considering their acceptability, engagement and absorption of the information and skills imparted. Thus, Magis-A Magical Adventure which is a therapeutic game based on Acceptance and commitment therapy aiming to enhance psychological flexibility will be tested for its effectiveness in the study with a purpose to unravel the efficient yet acceptable intervention promoting positive mental health among adolescents. 

Study Hypotheses:

Ha1: There is a significant difference in the levels of psychological flexibility; subjective, academic and behavioural well-being, post-intervention, among the adolescents in the experimental group, when compared to those in the control group, who do not receive the intervention.

Ha2: There is a significant difference in the pre and post-intervention levels of psychological flexibility, subjective well-being, academic and behavioural well-being, among the early adolescents in the experimental and waitlist-control groups.


 
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