| CTRI Number |
CTRI/2024/09/073470 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
overcoming digital/video gaming addiction , the intervention is for adolescents aged 13-15 years in chennai |
|
Scientific Title of Study
|
Development and validation of an integrated interventional module for combatting gaming addiction among adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
smrithi L |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
Department of mind body medicine and lifestyle sciences
sri ramachandra institute of higher education and research
Chennai
TAMIL NADU
600116
India |
| Phone |
9444160816 |
| Fax |
|
| Email |
smrithil@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
D C Mathangi |
| Designation |
Professor and Head, Department of Mind body medicine and lifestyle sciences |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
Department of mind body medicine and lifestyle sciences, sri ramachandra institute of higher education and research
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
D C Mathangi |
| Designation |
Professor and Head, Department of Mind body medicine and lifestyle sciences |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
Department of mind body medicine and lifestyle sciences, sri ramachandra institute of higher education and research
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| UNIVERSITY FELLOWSHIP/ Founder-chancellor shri. N.P.V Ramasamy Udayar Research Fellow from SRI Ramachandra Institute of higher education and research. Study will be conducted in kendriya vidyalaya school- island ground |
|
|
Primary Sponsor
|
| Name |
Sri ramachandra institute of higher education and research |
| Address |
sri ramachandra institute of higher education and research, porur chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D C Mathangi |
Kendriya Vidyalaya - Island grounds |
37HH+349, Pallavan Salai, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU |
044-29570350
kvigch2@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adolescents aged 13-15 years without pre existing mental health conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Psychological methods of reducing gaming addiction |
Module will include interventions like Cognitive behaviour therapy, mindfulness based cognitive therapy, play therapy, group therapy , sessions, De-sensitisation sessions for reducing gaming addiction impulsivity . the duration of the study is for 6 weeks, each intervention for one day a week for 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Adolescents aged between 13 and 15 years.
2.Undergoing regular education under full-time schooling
3.adolescents willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Any pre-existing mental health condition that may interfere with the study outcomes.
2. rejection from parents of child to participate in the program
3. Sudden physical illness which prevents them from participating in the intervention program |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gaming Addiction Symptom Severity |
Baseline assessment before the first session, post-intervention assessment within 1-2 weeks after the final session (week 6), and an optional follow-up at 3 months (month 4) to see if effects last. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DASS-21 DEPRESSION , ANXIETY AND STRESS SCALE |
Baseline assessment before the first session, post-intervention assessment within 1-2 weeks after the final session (week 6), and an optional follow-up at 3 months (month 4) to see if effects last. |
| Brief Sensation Seeking Scale (BSSS-8) |
Baseline assessment before the first session, post-intervention assessment within 1-2 weeks after the final session (week 6), and an optional follow-up at 3 months (month 4) to see if effects last. |
| Barratt Impulsiveness Scale-15 (BIS-15) |
Baseline assessment before the first session, post-intervention assessment within 1-2 weeks after the final session (week 6), and an optional follow-up at 3 months (month 4) to see if effects last. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2025 |
| Date of Study Completion (India) |
06/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Gaming addiction poses significant challenges for adolescent mental health, yet effective interventions tailored to this demographic remain scarce. This study addresses this gap by developing and evaluating an integrated intervention module aimed at combating gaming addiction among adolescents. By drawing upon established psychological theories including cognitive-behavioral theory, self-determination theory, and social learning theory, the intervention aims to provide a comprehensive approach to address the complex nature of gaming addiction. Through qualitative exploration and pilot testing, the study seeks to identify the causes, symptoms, and effects of gaming addiction among adolescents and assess the feasibility and initial efficacy of the intervention in reducing addiction severity and improving mental health outcomes. This research aims to contribute valuable insights into effective strategies for combating gaming addiction among adolescent populations. |