| CTRI Number |
CTRI/2026/01/101263 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of a Health Education Program on Emotional Wellbeing and Life Skills among Adolescents |
|
Scientific Title of Study
|
Explore the emotional health and assess the effectiveness of Health promotion Utility Terminal on psychosocial wellbeing, emotional intelligence and biophysiological parameters among adolescents at selected settings - a mixed methods approach
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Ambika R |
| Designation |
Assistant Professor |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Room No 2
Child Health Nursing Department
Omayal Achi College of Nursing
No.45 Ambattur road
Puzhal
Chennai
Room No 2
Child Health Nursing Department
Omayal Achi College of Nursing
No.45 Ambattur road
Puzhal
Chennai
Thiruvallur
TAMIL NADU
600066
India |
| Phone |
9944891009 |
| Fax |
|
| Email |
ambikarathinam1002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Ambika R |
| Designation |
Assistant Professor |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Room No 2
Child Health Nursing Department
Omayal Achi College of Nursing
No.45 Ambattur road
Puzhal
Chennai
Room No 2
Child Health Nursing Department
Omayal Achi College of Nursing
No.45 Ambattur road
Puzhal
Chennai
Thiruvallur
TAMIL NADU
600066
India |
| Phone |
9944891009 |
| Fax |
|
| Email |
ambikarathinam1002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ambika R |
| Designation |
Assistant Professor |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Room No 2
Child Health Nursing Department
Omayal Achi College of Nursing
No.45 Ambattur road
Puzhal
Chennai
Room No 2
Child Health Nursing Department
Omayal Achi College of Nursing
No.45 Ambattur road
Puzhal
Chennai
Thiruvallur
TAMIL NADU
600066
India |
| Phone |
9944891009 |
| Fax |
|
| Email |
ambikarathinam1002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ms. Ambika R
Assistant Professor
Room No.3, Child Health Nursing Department,
Omayal Achi College of Nursing,
No 45, Ambattur Road
Puzhal
Chennai
Tamilnadu
600066 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| DrDarcus Deva Sinthiya |
ICDS Centre,Periasozhiyampakkam |
Perumal Koil Street,
Gumudipoondi post,
Tiruvallur district
601206
Thiruvallur
TAMIL NADU |
9840679152
sinthiyadass@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTERNATIONAL CENTRE FOR COLLABORATIVE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Well being of Adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
As usual routine |
Participants in the control group will continue their routine school activities and will not receive the structured health promotion programme for a period of 6 months |
| Intervention |
Health Promotion Programme |
A structured health promotion programme focusing on emotional health. It includes interactive sessions on emotional awareness, stress management, coping skills, positive thinking and self-regulation. The supplementation of pearl millet ball and moringa powder to be given to them. The programme will be delivered through lectures, group discussions, activities and audiovisual aids. Sessions will be conducted for the intervention group for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents will be selected to explore emotional health
Adolescents who can understand Tamil or English
Parents who were willing to allow the adolescents to participate in the study
Adolescents who are score high, middle and low level from screening tool
|
|
| ExclusionCriteria |
| Details |
Adolescents who are not willing to participate in the study
Adolescents who are undergoing any kind of health promotion regimen
Parents who are not willing to allow their children to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in emotional well-being and emotional intelligence scores among adolescents after the health promotion intervention |
within 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in coping skills, reduction in perceived stress, better emotional regulation, increased self-awareness, and enhancement of interpersonal skills among adolescents following the health promotion intervention. These outcomes will be assessed at baseline and after completion of the intervention. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="240"
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)
|
10/02/2026 |
| 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="0"
Months="6"
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
|
This study aims to explore the emotional health of adolescents and assess the effectiveness of a structured health promotion programme on their emotional well-being and emotional intelligence. A non-randomized parallel group design will be used, including an intervention group and a control group. Adolescents aged 13–18 years studying in selected schools will be recruited. The intervention group will receive a structured health promotion programme focusing on emotional awareness, stress management, coping skills, positive thinking, and self-regulation, while the control group will continue with routine school activities. Outcomes will be measured at baseline and post-intervention using standardized assessment tools. The findings of this study will help in understanding the impact of health promotion strategies on adolescents’ emotional health and overall well-being. |