| CTRI Number |
CTRI/2026/01/102566 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is done to find out whether a planned teaching programme helps school-going adolescents in Wardha to better understand the harmful effects of alcohol and to learn how to say “no” when someone offers them alcohol. |
|
Scientific Title of Study
|
A study to assess the effectiveness of a planned teaching programme on knowledge regarding alcohol use and refusal skills in adolescents in Wardha school. |
| 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 Gunjan P Telrandhe |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Reseach Sawangi Meghe |
| Address |
Mental Health Nursing Dept SRMMCON Building Ground Floor Datta Meghe Institute of Higher Education and Reseach Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9373750174 |
| Fax |
|
| Email |
gptelrandhe15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Uke |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Reseach Sawangi Meghe |
| Address |
Mental Health Nursing SRMMCON Building Ground Floor Datta Meghe Institute of Higher Education and Reseach Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7387983483 |
| Fax |
|
| Email |
truptigote28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Uke |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Reseach |
| Address |
Mental Health Nursing SRMMCON Building Ground Floor Datta Meghe Institute of Higher Education and Reseach Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7387983483 |
| Fax |
|
| Email |
truptigote28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Trupti Uke |
Datta Meghe Institute of Higher Education & Research |
Mental Health Nursing Ground Floor SRMMCON Building Datta Meghe Institute of Higher Education & Research
Wardha
MAHARASHTRA |
7387983483
truptigote28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Alcohol Use and Refusal Skills in Adolscents in schools |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Planned Teaching Session |
7 day Planned Teaching Regarding Alcohol Use and Refusal Skills in adolescents in Schools |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1. school at the time of data collection.
2. Able to understand and respond in the language used for the tool (e.g.,English/vernacular used in the school).
3. Present on the day of data collection and willing to participate.
4. Provide written informed assent (adolescent) and written parental/guardian consent
|
|
| ExclusionCriteria |
| Details |
1. Known history of alcohol dependence or currently undergoing treatment for substance use (to avoid confounding).
2. Absent on both scheduled data collection days or unwilling to give assent/consent.
3. Any acute medical or psychiatric condition at the time of data collection that may interfere with participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge regarding alcohol use and refusal skills in adolescents in schools |
Assessment will be done in 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2026 |
| 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 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 - NO
|
|
Brief Summary
|
The planned teaching programme will serve as a comprehensive educational strategy to enhance the knowledge and refusal skills of adolescents regarding alcohol use. Through interactive discussions, demonstrations, and role plays, students will gain awareness about the ill effects of alcohol and will learn practical ways to resist peer pressure. The programme will aim to promote positive behavior, strengthen decision-making abilities, and empower adolescents to make healthier choices for their well-being. |