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CTRI Number  CTRI/2026/01/101299 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Cluster Randomized Trial 
Public Title of Study   What is the Effect of climate resilience strategy intervention on climate change awareness and preparedness among adolescent children ? 
Scientific Title of Study   Mixed-method study on the impact of climate change on mental health among adolescents: Intended to implement climate resilience strategies through Ayushman Bharat’s School Health and Wellness Program. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  HEPSI BAI JOSEPH 
Designation  ASST PROFESSOR 
Affiliation  AIIMS BHUBANESWAR 
Address  Room no 104 First floor COLLEGE OF NURSING AIIMS BHUBANESWAR Sijua Patrapada BHUBANESWAR
Room no 104 first floor COLLEGE OF NURSING AIIMS BHUBANESWAR Sijua Patrapada BHUBANESWAR
Khordha
ORISSA
751019
India 
Phone  06380146509  
Fax    
Email  nurs_hepsi@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  HEPSI BAI JOSEPH 
Designation  ASST PROFESSOR 
Affiliation  AIIMS BHUBANESWAR 
Address  ROOM 104, FIRST FLOOR, COLLEGE OF NURSING, AIIMS, BHUBANESWAR
ROOM 302, 2ND FLOOR, Aiims Housing Complex, Sijua, Patrapada
Khordha
ORISSA
751019
India 
Phone  6380146509  
Fax    
Email  nurs_hepsi@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  HEPSI BAI JOSEPH 
Designation  ASST PROFESSOR 
Affiliation  AIIMS BHUBANESWAR 
Address  ROOM NO 104 FIRST FLOOR COLLEGE OF NURSING Sijua Patrapada AIIMS BHUBANESWAR
ROOM NO 302 SECOND FLOOR AIIMS Housing Complex Sijua Patrapada BHUBANESWAR
Khordha
ORISSA
751019
India 
Phone  6380146509  
Fax    
Email  nurs_hepsi@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  ICMR 
Address  Ramalingaswami Bhawan Ansari Nagar New Delhi 110029 India 
Type of Sponsor  Government funding agency 
 
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 
HEPSI BAI JOSEPH  KV SCHOOLS  BHUBANESWAR,KHORDHA
Khordha
ORISSA 
06380146509

nurs_hepsi@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY SCHOOL CHILDREN 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  climate resilience strategies   Climate resilience strategies refer to the structured school-based intervention programs designed and implemented under the Ayushman Bharat School Health and Wellness framework. It comprises five classroom modules designed to enhance adolescents’ knowledge, adaptive behaviors, and coping capacity regarding climate change, with a focus on heatwave preparedness. The modules include: 1. Introduction to climate change and heat waves 2. Health impacts of heat waves 3. Hydration and nutrition during heat waves 4. Heat wave safety at home and school 5. Building a climate resilience mindset  
Comparator Agent  routine school health programme  Routine medical school health check-up  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Adolescents studying 8th to 10th standard
Adolescents who Present during the data collection in the selected school
Adolescents who are Willing to participate in the study
 
 
ExclusionCriteria 
Details  Adolescents who have any mental illness and are on treatment. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
c) To assess the effectiveness of climate resilience strategies on climate change readiness among adolescents   c) To assess the effectiveness of climate resilience strategies on climate change readiness among adolescents  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="240" 
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)   15/11/2026 
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)   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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nurs_hepsi@aiimsbhubaneswar.edu.in].

  6. For how long will this data be available start date provided 02-06-2026 and end date provided 02-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study uses a cluster randomized controlled trial design to assess the effectiveness of climate resilience strategies on climate change readiness among adolescents. The study will be conducted in public schools of selected blocks in Khordha district Odisha where the Ayushman Bharat Health and Wellness Programme is implemented.

The sample size was estimated using evidence from a previous study on climate change knowledge gaps. Based on pretest and posttest knowledge scores with alpha 0.05 power 80 percent and effect size 0.32 the initial sample size was 155 participants per group. This was adjusted for the cluster randomized design using a design effect assuming an average cluster size of 40 and an intraclass correlation coefficient of 0.01. After adjusting for 10 percent attrition the final sample size is 240 adolescents in the experimental group and 240 in the control group. A multistage cluster random sampling technique will be used.

The study participants include adolescents studying in 8th to 10th standard who are present during data collection and willing to participate. Adolescents with diagnosed mental illness and currently on treatment will be excluded.

The intervention consists of a classroom based climate change resilience training focusing on heat wave preparedness. The training includes five sessions of 45 to 60 minutes delivered over one month with booster sessions at two months. The module was refined through stakeholder consultations and focus group discussions with adolescents. It includes five components covering climate change and heat waves health impacts of heat waves hydration and nutrition heat wave safety at home and school and building a climate resilience mindset. Control schools will continue routine classroom teaching.

Outcome assessment focuses on climate change readiness across four domains namely awareness and action towards climate change climate change protective behaviors climate change hope and practice of climate change prevention behaviors. Validated structured questionnaires and scales will be used and higher scores indicate better climate change readiness among adolescents.

 

 
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