| 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
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ramalingaswami Bhawan
Ansari Nagar
New Delhi
110029
India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| 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
|
|
|
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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nurs_hepsi@aiimsbhubaneswar.edu.in].
- 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.
- 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. |