| CTRI Number |
CTRI/2024/11/077115 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Using Social Marketing to improve child-family relationships, Alcohol usage and Sexual health issues attributable to Social Media Usage Among Adolescents in North India. |
|
Scientific Title of Study
|
Social Marketing Intervention for adverse Child-family relationships, Alcohol-usage and Sexual-health Issues attributable to Social-Media-Usage among Adolescents: A Multi-City Cluster Randomized Controlled Trial in North-India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanvi Kiran |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Room no 128, Department of Community Medicine and School of Public Health
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876867850 |
| Fax |
|
| Email |
kiran.tanvi@pgimer.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanvi Kiran |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Room no 128, Department of Community Medicine and School of Public Health
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876867850 |
| Fax |
|
| Email |
kiran.tanvi@pgimer.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvi Kiran |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Room no 128, Department of Community Medicine and School of Public Health
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876867850 |
| Fax |
|
| Email |
kiran.tanvi@pgimer.edu.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Education and Research (ICMR), New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr. Tanvi Kiran |
| Address |
Room No 128, Department of Community Medicine and School of Public Health, PGIMER |
| Type of Sponsor |
Other [SELF] |
|
|
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 Tanvi Kiran |
Post Graduate Institute of Medical Education and Research (PGIMER) |
Room No 128, Department of Community Medicine and School of Public Health, PGIMER
Chandigarh
CHANDIGARH |
9876867850
kiran.tanvi@pgimer.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents aged 14-17 enrolled in classes 9th to 12th having personal social media accounts accessible using internet enabled smartphones/tablets/laptops/desktops.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Simple basic behavioural Intervention |
The control group shall be given some basic intervention involving simple counselling and awareness sessions to limit social media use.
The frequency of the Basic counselling and awareness sessions shall be once per month for a period of 3 months. Duration of the session will be 10-15 minutes for each participant. |
| Intervention |
Social Marketing Intervention |
A novel Social Marketing Intervention intended for behaviour modification is planned for three months, once per month will be implemented at student, school, and parental levels.
Student Level-
Month 1-The intervention will include 45 minutes to 1 hour of monthly group counseling and awareness sessions and relevant IEC material on social media usage, alcohol usage, sexual health, and child-family relationships.
Month 2-This phase will leverage the power of social media platforms to disseminate information widely and effectively. Besides delivering the counseling sessions to the students, dedicated social media pages will be created to engage the target audience. Infographics, flyers, and pamphlets will be created and shared across these social media platforms.
Month 3- In addition to 1st and 2nd month activities, the 3rd month will focus on implementing a dynamic approach by combining social marketing campaigns and extracurricular activities, coinciding with the parent-teacher meeting at the school. This initiative aims to actively engage parents and teachers in promoting behavioural change among students. Social marketing campaigns will be implemented to convey key messages effectively, utilizing various mediums like dedicated radio slots, Facebook pages, Whatsapp group messages, and newspaper advertisements to market the planned campaign shall be utilized to reach a wider audience. Additionally, extracurricular activities, such as quiz competitions, slogan writing, 2 minutes speak up, etc addressing topics like alcohol usage, social media habits, child-family relationships, alcohol consumption, as well as sexual health issues, will be organized during the parent-teacher meeting.
School level- Teachers shall be trained to facilitate sessions. Teachers will play a pivotal role in the course of implementing group sessions. Following a sensitization workshop, teachers will undergo pre-intervention training to ensure the sustainability of the social marketing campaign within the school environment for the long term. This training is designed to enable teachers to actively facilitate group sessions on excessive social media usage, child-family relationships, alcohol consumption, and sexual health issues, fostering a collaborative and engaging environment. By actively involving teachers in the execution of these sessions, the campaign becomes ingrained in the schools culture, ensuring its enduring impact.
Parental level- the devised intervention will be disseminated through various communication channels to ensure widespread awareness and engagement among parents. Information will be shared with parents via popular social media platforms such as WhatsApp and email groups. For parents without access to WhatsApp, communication will be facilitated through telephone calls. Social marketing intervention will be reinforced by providing informative handouts during parent-teacher meetings. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria include all the following points-
1) School-going adolescents aged 14-17 years, encompassing all genders and enrolled in classes 9th to 12th within government or private schools of the Tricity (Cities of Chandigarh, Panchkula, Mohali).
2) Adolescents who provide their assent along with parental consent to participate in this study.
3) Adolescents who have smartphones/tablets/laptops with their own social media accounts. |
|
| ExclusionCriteria |
| Details |
The participant falling under any of the following categories will be excluded-
1) Adolescents below 14 or above 17 years old in classes 9th to 12th.
2) Adolescents who do not provide their assent or if their parents do not provide consent to participate in this study
3) Adolescents who do not have access to smartphones or internet access to use their social media accounts.
4) An adolescent having been diagnosed with mental health problems or other chronic medical diseases.
5) Parents and teachers who refuse to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Average amount of time spent on social media
2) Proportion of students witnessing excessive social media usage
3) Frequency of alcohol usage
4) Binge drinking episodes
5) Harmful alcohol use episodes (causing violence/injury under alcohol use)
6) Average amount of time spent with parents
7) Frequency of Open/ direct/ face-to-face communication with parents
8) Proportion of child-parents conflict
9) Amount of knowledge regarding sexual health/ physical relation
10)Proportion of students having knowledge regarding protective sexual behaviour |
1) Baseline (outcomes will be measured after 3 months of the start date of the project)
2) Outcomes will be measured immediately post-intervention
3) Outcomes will be measured one month post-intervention
4) Outcomes will be measured two months post-intervention
5) Outcomes will be measured three months post-intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) The proportion of students using unprotected sexual behaviour
2) Reduction in risky sexual behaviour episodes, if any
|
1) Baseline (outcomes will be measured after 3 months of the start date of the project)
2) Outcomes will be measured immediately post-intervention
3) Outcomes will be measured one month post-intervention
4) Outcomes will be measured two months post-intervention
5) Outcomes will be measured three months post-intervention
|
|
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Target Sample Size
|
Total Sample Size="1260"
Sample Size from India="1260"
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)
|
01/08/2025 |
| 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 Yet Recruiting |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kiran.tanvi@pgimer.edu.in].
- For how long will this data be available start date provided 21-01-2027 and end date provided 31-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
With increasing digital use, especially in North India, there is a paucity of literature on pathways and connections between social media use and attributable family relationships, alcohol use, and sexual health issues. A novel social marketing intervention is planned to effectively address the aforementioned adolescent health issues early on and build a mutually beneficial interface between parents, school-going adolescents, school authorities, and health professionals. The study aims to explore the impact of social media use on alcohol consumption, sexual health, and adverse child-family relationships among adolescents. Additionally, it proposes the development, implementation, and economic evaluation of Social Marketing Intervention to address these issues and promote adolescent well-being in the digital age. A cluster randomized controlled trial is planned on school-going adolescents (aged 14-17 years) covering 12 schools across Tricity of Chandigarh, Panchkula (Haryana) and Mohali (Punjab). Formative research shall be conducted to design a novel Social-Marketing intervention to dynamically influence behaviour change among adolescents wherein parents and teachers shall also play as key stakeholders in facilitating the intended behaviour change. Intervention shall be given on monthly basis for 3 months with monthly follow-up for three months. Generalized-Estimating-Equations modelling shall be undertaken to assess the study outcomes at different periods. Hybrid economic simulation (Decision Tree and Markov model) is proposed to be used for cost-effectiveness analysis. Cost-effective analysis can provide some insight for policy-makers to plan for introducing the intervention on a larger scale in the Indian context. |