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CTRI Number  CTRI/2025/09/095507 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Helping College Students in Delhi (18+ years) Say No to Tobacco: A Study on Refusal Skill Training to Improve Motivation and Confidence 
Scientific Title of Study   A quasi-experimental study to assess the effectiveness of Refusal Skill Training on motivation and self-efficacy on tobacco use among college students aged 18+ in selected colleges of Delhi. 
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 Sushil Kumar Maheshwari 
Designation  Associate Professor, HOD 
Affiliation  Institute of Human Behaviour and Allied Sciences 
Address  Department of Psychiatric Nursing, Institute of Human Behaviour and Allied Sciences, Delhi

East
DELHI
110095
India 
Phone  93568644460  
Fax    
Email  drsushilihbas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushil Kumar Maheshwari 
Designation  Associate Professor, HOD 
Affiliation  Institute of Human Behaviour and Allied Sciences 
Address  Department of Psychiatric Nursing, Institute of Human Behaviour and Allied Sciences, Delhi

East
DELHI
110095
India 
Phone  93568644460  
Fax    
Email  drsushilihbas@gmail.com  
 
Details of Contact Person
Public Query  
Name  SYAM S C 
Designation  MSc Nursing Student 
Affiliation  Institute of Human Behaviour and Allied Sciences 
Address  Department of Psychiatric Nursing, Institute of Human Behaviour and Allied Sciences, Delhi

East
DELHI
110095
India 
Phone  09809268901  
Fax    
Email  syamsasi.sc@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SYAM S C 
Address  Department of Psychiatric Nursing, Institute of Human Behaviour and Allied Sciences, Delhi 
Type of Sponsor  Other [Self-Sponsored] 
 
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 Sushil Kumar Maheshwari  Institute of Human Behaviour and Allied Sciences  Dept of Psychiatric Nursing, College of Nursing, LH no-1, IHBAS
East
DELHI 		 09356864460

drsushilihbas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,IHBAS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tobacco use among college students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no structured refusal skill training during the study period  Control group will receive routine health education provided by the college. after the study Refusal Skill Training will be offered to them 
Intervention  Refusal Skill Training sessions  structured interactive group sessions focusing on assertive communication, coping with peer pressure, and motivation to quit tobacco 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  College students aged 18 years and above
Current users of tobacco in any form
Willing to participate and provide informed consent
 
 
ExclusionCriteria 
Details  Students undergoing treatment or previous experience of tobacco cessation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in motivation to quit tobacco use (measured using a standardized Motivation Scale for Tobacco Cessation).

Change in self-efficacy related to refusal skills (measured using a validated Self-Efficacy/Refusal Skills Questionnaire). 		 at baseline, immediate post-intervention, and 1 month follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in frequency of tobacco use (self-reported past 30 days use) at baseline and 1 month follow-up.”

“Improvement in knowledge regarding harmful effects of tobacco at baseline and 1 month follow-up.” 		 at baseline and 1 month follow-up 
 
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   N/A 
Date of First Enrollment (India)   20/10/2025 
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="0"
Months="1"
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  

Title of Study
A Quasi-Experimental Study to Assess the Effectiveness of Refusal Skill Training on Motivation and Self-Efficacy on Tobacco Use among College Students Aged 18+ in Selected Colleges of Delhi

Background & Rationale
Tobacco use among college students (18–24 years) in India remains a major public health issue, influenced by peer pressure, stress, and poor enforcement of tobacco laws. Existing interventions largely focus on awareness but neglect psychological determinants such as motivation and self-efficacy, which are critical for long-term cessation. Few experimental studies exist in urban college settings. This study addresses these gaps using a structured refusal skill training (RST) intervention.

Objectives

  1. Assess baseline levels of motivation and self-efficacy among tobacco-using college students.

  2. Develop and implement refusal skill training (RST) for the experimental group.

  3. Evaluate the effectiveness of RST on motivation and self-efficacy between experimental and control groups.

  4. Examine associations between selected demographic variables and outcomes.

Methodology

  • Design: Quasi-experimental, pretest–posttest control group.

  • Population: College students aged 18+ years, current tobacco users.

  • Sample Size: 120 (60 experimental, 60 control; accounting for attrition).

  • Sampling: Convenient selection of colleges; simple random sampling of students.

  • Intervention: 1-day workshop (5 sessions) on refusal skills, motivation, and self-efficacy.

  • Tools:

    • Adapted Global Youth Tobacco Survey (GYTS)-based questionnaire (motivation).

    • Tobacco Refusal Self-Efficacy Questionnaire (TRSEQ).

  • Data Collection: Pre-test, immediate post-test, and short follow-up.

Hypotheses

  • RST will significantly improve motivation and refusal self-efficacy compared to control.

  • Demographic variables will show associations with intervention outcomes.

Ethical Considerations

  • IEC approval obtained from IHBAS.

  • Written informed consent will be taken.

  • Confidentiality and voluntary participation ensured.

Expected Outcomes

  • Significant improvement in motivation and refusal self-efficacy among experimental group.

  • Evidence to support integration of RST in college wellness programs.

Implications

  • Scale-up to multiple campuses.

  • Shift from awareness-based to skill-based interventions.

  • Basis for digital reinforcement and long-term follow-up studies.

 
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