| CTRI Number |
CTRI/2024/12/077651 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparison of role play with lecture method in bringing about change in behaviour regarding tobacco consumption and its side effects in rural adolescents - A cluster randomized control trial |
|
Scientific Title of Study
|
Role play or Lecture : Which is more effective in addressing rural adolescents regarding changing the knowledge of Tobacco consumption and its side effects - A cluster randomized control 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 |
DrPruthviP |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Community Medicine, Sri Devaraj Urs Medical College
Kolar
KARNATAKA
563101
India |
| Phone |
9739073381 |
| Fax |
|
| Email |
22pg012@sduaher.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPruthviP |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Community Medicine, Sri Devaraj Urs Medical College
Kolar
KARNATAKA
563101
India |
| Phone |
9739073381 |
| Fax |
|
| Email |
22pg012@sduaher.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPruthviP |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Community Medicine, Sri Devaraj Urs Medical College
Kolar
KARNATAKA
563101
India |
| Phone |
9739073381 |
| Fax |
|
| Email |
22pg012@sduaher.com |
|
|
Source of Monetary or Material Support
|
| MAMTHA HEALTH INSTITUTE FOR MOTHER AND CHILD
B-5 Greater Kailash Enclave-II, New Delhi 110048, India. |
|
|
Primary Sponsor
|
| Name |
MAMTHA HEALTH INSTITUTE FOR MOTHER AND CHILD |
| Address |
B-5, GREATER KAILASH ENCLAVE-II, NEW DELHI, 110048, India. |
| Type of Sponsor |
Other [NGO] |
|
|
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 PruthviP |
SDUMC, SDUAHER |
List of place of schools selected for the study - Uthnoor, Devarayasamudra, Hanumanahalli, Kothamangla, Avani, Yelagondanahalli, Kashipura, Urgunte, Kembodi, Mudinoor, Butterahalli, H Gollahalli, T Gollahalli, Aralkunte, Dimba, Vadguru, Eragasandra, Karahalli, Tekal, and Toralahalli.
Kolar
KARNATAKA |
9739073381
pruthvimsp3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, SDUAHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
IMPROVING THE KNOWLEDGE
AND AWARENESS IN ADOLESCENTS REGARDING SUBSTANCE ABUSE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LECTURE ABOUT THE ILL EFFECTS OF TOBACCO CONSUMPTION IN ADOLESCENTS. |
Lecture method Health education (not lasting 30-45 minutes) will be given by Community
Medicine Post graduate.
The content of the lecture will be validated and standerdized with help of subject experts.
The above said intervention will be done on 0(1st contact), 3 and 6 months to the school
students randomly selected, after which an informative leaflet will also be distributed to
the students for reinforcement of the harmful effects of tobacco use.
The change in knowledge among adolescent school children regarding Tobacco
consumption and its side effects will be tested at the time gap of 1Week, 3months and 6
months. |
| Intervention |
ROLEPLAY DEPECTING THE ILL EFFECTS OF TOBACCO CONSUMPTION IN ADOLESCENTS. |
Role play will be done by Community Medicine interns (not lasting more than 30-45
minutes) based on module developed. It will be validated and standardized with subject experts.
The above said intervention will be done on 0(1st contact), 3 and 6 months to the school
students randomly selected, after which an informative leaflet will also be distributed to
the students for reinforcement of the harmful effects of tobacco use.
The change in knowledge among adolescent school children regarding Tobacco
consumption and its side effects will be tested at the time gap of 1week, 3months and 6
months. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All adolescents aged 14 -18 years belonging to 9th and 10th standard will be included in study after consent and assent. |
|
| ExclusionCriteria |
| Details |
1. Adolescents with any preexisting mental health illness (like already diagnosed severe depression, etc.) will be excluded.
2. Children who remain absent on the day of intervention will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Through the present study we would see which Information Education and Communication method can be effective in
adolescent children to bring change in knowledge comparing the lecture with role play. |
Through the present study we would see which Information Education and Communication method can be effective in
adolescent children to bring change in knowledge comparing the lecture with role play.
This will be assessed at 0(1st contact), 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
28/01/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - published article
- For how long will this data be available start date provided 01-08-2024 and end date provided 01-08-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Due to the enormous psychosocial and health effects of tobacco on youth, it is pertinent to understand its burden along with sociodemographic factors for formulating effective tobacco control measures targeting them. The traditional, lecture methods by health educators under the national program is questionable and criticized particularly by constructivists for failing to deliver deep and effective knowledge-changing experiences. Lack of awareness among people belonging to poor socioeconomic strata of the society, societal influence, and poor implementation of anti-tobacco laws could be the possible reasons for its widespread usage of all forms of tobacco asking for more rigorous anti-tobacco campaigns and widespread implementation of anti-tobacco regulations. Minimizing tobacco use can be done by strengthening the healthcare system to generate awareness, enable early detection, and implement strategies to prevent tobacco addiction among adolescents. The present study shows which Information Education and Communication methods can be effective in adolescent children to bring change in knowledge by comparing the lecture with role play. |