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CTRI Number  CTRI/2025/04/083912 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Preventing Substance Use Among Adolescents: A Community-based Study in Schools 
Scientific Title of Study   Evaluating the Effectiveness of a Community-based Peer-led Intervention (CPLI) in preventing Substance use among Adolescents: A Cluster Randomized Controlled Trial within School Health Programme under Ayushman Bharat 
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 U Venkatesh 
Designation  Assistant Professor, Department of Community and Family Medicine 
Affiliation  All India Institute of Medical Sciences, Gorakhpur 
Address  Department of Community and Family Medicine, All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh- 273008.

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  7379399332  
Fax    
Email  venkateshu.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr U Venkatesh 
Designation  Assistant Professor, Department of Community and Family Medicine 
Affiliation  All India Institute of Medical Sciences, Gorakhpur 
Address  Department of Community and Family Medicine, All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh- 273008.


UTTAR PRADESH
273008
India 
Phone  7379399332  
Fax    
Email  venkateshu.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr U Venkatesh 
Designation  Assistant Professor, Department of Community and Family Medicine 
Affiliation  All India Institute of Medical Sciences, Gorakhpur 
Address  Department of Community and Family Medicine, All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh- 273008.


UTTAR PRADESH
273008
India 
Phone  7379399332  
Fax    
Email  venkateshu.aiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Nagpur, Maharashtra, India. 441108 
All India Institute of Medical Sciences (AIIMS) Deoghar, Daburgram, Jasidih, Deoghar, Jharkhand, India, 814142 
All India Institute of Medical Sciences, Department of Community and Family Medicine, Kunraghat, Gorakhpur, Uttar Pradesh 273008, India 
All India Institute of Medical Sciences, Guwahati Silbharal, Changsari, Guwahati, Assam 781101, India 
All India Institute of Medical Sciences, Khanderi, Para Pipaliya, Rajkot, Gujarat, 360110, India 
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER): Dhanvantari Nagar, Gorimedu, Puducherry - 605 006, India. 
 
Primary Sponsor  
Name  ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aravind Gandhi P   All India Institute of Medical Sciences   All India Institute of Medical Sciences (AIIMS), Nagpur, Maharashtra, India.
Nagpur
MAHARASHTRA 		 9585395395

aravindsocialdoc@gmail.com 
Dr Himashree Bhattacharyya  All India Institute of Medical Sciences  All India Institute of Medical Sciences, Guwahati Silbharal, Changsari, Guwahati, Assam 781101, India
Kamrup
ASSAM 		 9436985886

himashreebhattacharyya@gmail.com 
Dr Krupal Jagdish Chandra Joshi  All India Institute of Medical Sciences  Khanderi, Para Pipaliya, Rajkot, Gujarat, 360110
Rajkot
GUJARAT 		 9974872609

Dr.krupaljoshi@gmail.com 
Dr Sudip Bhattacharya  All India Institute of Medical Sciences  All India Institute of Medical Sciences (AIIMS) Deoghar, Daburgram, Jasidih, Deoghar, Jharkhand, India, 814142
Deoghar
JHARKHAND 		 8872397092

sudipbhattacharya234@gmail.com 
Dr U Venkatesh  All India Institute of Medical Sciences   All India Institute of Medical Sciences, Department of Community and Family Medicine, Room number: 230, 2nd Floor, MNC bulding, Kunraghat, Gorakhpur, Uttar Pradesh 273008, India
Gorakhpur
UTTAR PRADESH 		 7379399332

venkateshu.aiims@gmail.com 
Dr Palnivel C   Jawaharlal Institute of Postgraduate Medical Education Research   Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER): Dhanvantari Nagar, Gorimedu, Puducherry - 605 006, India.
Pondicherry
PONDICHERRY 		 9787825827

palanive.c@jipmer.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Substance Use Prevention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioral education  Intervation for the one year, Duration is two year 
Comparator Agent  No behavioral education  Duration: 2 years 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  Adolescents enrolled in participating schools
able to provide assent (with parental/guardian consent) and willing to participate in the intervention and follow-up assessments 
 
ExclusionCriteria 
Details  Severe cognitive or physical impairments hindering participation.
Adolescents already enrolled in specialized substance use treatment programs.
Inability to obtain informed consent/assent. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes include assessing the risk perception of substance use, measuring substance use frequency both pre- and post-intervention, and evaluating attitudes toward substance use prevention. These outcomes will provide insights into the direct impact of the intervention on adolescents’ awareness and behaviors related to substance use.  At Baseline, 6, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes focus on the broader implications of the intervention, including observed behavioral changes related to substance use, levels of community and parental engagement, and the feasibility, fidelity, and sustainability of the intervention over time. These outcomes are critical for understanding the long-term effectiveness and scalability of the program.  12 months 
 
Target Sample Size   Total Sample Size="5400"
Sample Size from India="5400" 
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)   01/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This cluster randomized controlled trial (cRCT) evaluates the effectiveness of integrating the Community-based Peer-led Intervention (CPLI) with the School Health Programme (SHP) under Ayushman Bharat to prevent substance use among adolescents in India. The primary hypothesis is that the CPLI intervention will significantly reduce substance use behaviors (e.g., tobacco, alcohol, marijuana) among adolescents by enhancing risk perception, fostering peer-led support, and addressing contextual factors like familial and community norms.

 The trial employs a mixed-methods design, combining quantitative assessments (e.g., Substance Use Risk Profile Scale [SURPS] scores, self-reported substance use frequency) and qualitative insights (focus group discussions with adolescents, parents, and stakeholders). Schools (n=108) across diverse Indian settings (urban, rural, tribal) are randomized into intervention (CPLI + SHP) or control (standard SHP) arms.

 
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