| CTRI Number |
CTRI/2025/10/095615 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Screening Process of Care Changes Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
From Stress to Strength: A School-Based Program to Support Adolescents’ Well-Being in India |
|
Scientific Title of Study
|
A Targeted School-Based Intervention for Adverse Childhood Experiences:
Integrating Trauma-Informed Care to Promote Mental Health and Mitigate NCD
Risk in Indian Adolescents |
| Trial Acronym |
ACES trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavneet Bharti |
| Designation |
Director Principal |
| Affiliation |
Dr BR Ambedkar Institute of Medical Sciences , SAS Nagar Punjab |
| Address |
Admin Office of Director Principal
College Building
Dr BR Ambedkar State Institute of Medical Sciences Mohali SAS Nagar Punjab Admin Office of Director Principal
College Building
Dr BR Ambedkar State Institute of Medical Sciences Mohali SAS Nagar , Punjab Rupnagar PUNJAB 160055 India |
| Phone |
09914208327 |
| Fax |
|
| Email |
bhavneetsahul@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bhavneet Bharti |
| Designation |
Director Principal |
| Affiliation |
Dr BR Ambedkar Institute of Medical Sciences , SAS Nagar Punjab |
| Address |
Admin Office of Director Principal College Building
Dr BR Ambdedkar State Institute of Medical Sciences Mohali
SAS Nagar , Punjab Admin Office of Director Principal College Building
Dr BR Ambdedkar State Institute of Medical Sciences Mohali
SAS Nagar , Punjab Chandigarh CHANDIGARH 160055 India |
| Phone |
09914208327 |
| Fax |
|
| Email |
bhavneetsahul@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bhavneet Bharti |
| Designation |
Director Principal |
| Affiliation |
Dr BR Ambedkar Institute of Medical Sciences , SAS Nagar Punjab |
| Address |
Admin Office of Director Principal College Building
Dr BR Ambdedkar State Institute of Medical Sciences Mohali
SAS Nagar , Punjab Admin Office of Director Principal College Building
Dr BR Ambdedkar State Institute of Medical Sciences Mohali
SAS Nagar , Punjab Rupnagar PUNJAB 160055 India |
| Phone |
09914208327 |
| Fax |
|
| Email |
bhavneetsahul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) V Ramalingaswami Bhawan Ansari Nagar , New Delhi 110029 India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ICMR |
| Address |
Indian Council of Medical Research ICMR V 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 |
| Dr Bhavneet Bharti |
Dr BR Ambedkar State Institute of Medical Sciences Mohali Punjab |
Admin office , College Building
Dr BR Ambedkar State Institute of Medical Sciences
Mohali, SAS Nagar Rupnagar PUNJAB |
09914208327
bhavneetsahul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee-Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ACEs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evidence based Tauma Informed Intervention TIC |
Trauma Informed Intervention will be delivered for 8-12 Weeks in children who are screen positive for Adverse childhood experiences ACEs |
| Comparator Agent |
None |
If a child with Adverse Childhood experiences is identified , all children will be provided Trauma Informed care . No comparator is there |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Students from Public and Private schools of Chandigarh and Mohali (SAS Nagar)Punjab |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Adverse Childhood Experience (ACEs )among school going adolescents.
|
Complete Baseline data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pattern and distribution of specific ACEs (Adverse Childhood Experiences) categories
|
Baseline |
| 2.Association between demographic factors and ACEs (Adverse Childhood Experiences )exposure |
Baseline |
| 3.Comparison of ACE(Adverse Childhood Experiences) prevalence across different subgroups |
Baseline |
| 4.Frequency of co-occuring ACEs ( Adverse Childhood Experiences) |
Baseline |
| 5.Identification of high risk groups based on sociodemographic correlates |
Baseline |
| 6.Prevalence of Biobehavioral risk factors for Non communicable Diseases ( NCDs) among adolescents |
Baseline |
| Association between ACE scores and mental health status |
Baseline |
| Association between ACE scores and bio-behavioral risk factors |
Baseline |
| Completion of a structured,evidence based TIC intervention module. |
1 year |
| Reduction in emotional and behavioral symtoms,and depressive symptoms |
3 years |
| Improvement in school related functioning |
3 years |
|
|
Target Sample Size
|
Total Sample Size="1632" Sample Size from India="1632"
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)
|
27/10/2025 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Rationale/Gaps in Existing Knowledge: Adverse Childhood Experiences (ACEs) significantly predict lifelong mental and physical health outcomes. Despite extensive global evidence, India-specific data remains limited, particularly for adolescents. A comprehensive JAMA meta-analysis (2025) of 65 studies included only one Indian study, highlighting a critical knowledge gap. While Indian adolescents face increasing mental health challenges and academic pressure, evidence-based, culturallyappropriate trauma-informed interventions are notably absent in educational settings. Novelty: This pioneering study in North India integrates Social-Emotional Learning (SEL) with trauma-informed care for adolescents (Classes 8-12) in Mohali and Chandigarh schools. The innovative approach combines capacity building for educators with systematic screening and intervention, aligning with both the National Education Policy (NEP 2020) and National Mental Health Policy (2014). It uniquely addresses the intersection of ACEs, mental health, and early NCD risk factors within the Indian educational context. Objectives: To assess ACE prevalence and patterns among school-going adolescents evaluate associations between ACEs, mental health outcomes, and NCD risk factors and develop, implement, and evaluate a culturally-sensitive, school-based intervention program. Methods: A mixed-methods approach will employ validated ACE questionnaires, mental health assessments, and NCD risk screening tools, complemented by focus group discussions and key informant interviews. A structured 8-12 weeks intervention will be evaluated through pre-post assessments and process documentation. Expected Outcomes: The study will provide region-specific ACE data, establish an evidencebased intervention model, enhance school-based trauma-informed care capacity, and demonstrate improved mental health and NCD risk outcomes among adolescents. |