| CTRI Number |
CTRI/2024/10/075130 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility and outcomes of a life-skills intervention in adolescents experiencing extreme weather events |
|
Scientific Title of Study
|
Feasibility and short-term outcomes of a locally adapted life-skills intervention in adolescents experiencing chronic adversities: A multi-site study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joydeep Majumder |
| Designation |
Scientist E |
| Affiliation |
ICMR Centre for Ageing and Mental Health |
| Address |
ICMR Centre for Ageing and Mental Health
Department of Climate Change
Division of Mental Health
ROOM NO 3
BLOCK DP1
SECTOR V
SALTLAKE
Kolkata
WEST BENGAL
700091
India |
| Phone |
7874503436 |
| Fax |
|
| Email |
majumder.j@gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Joydeep Majumder |
| Designation |
Scientist E |
| Affiliation |
ICMR Centre for Ageing and Mental Health |
| Address |
ICMR Centre for Ageing and Mental Health
Department of Climate Change
Division of Mental Health
ROOM NO 3
BLOCK DP1
SECTOR V
SALTLAKE
Kolkata
WEST BENGAL
700091
India |
| Phone |
7874503436 |
| Fax |
|
| Email |
majumder.j@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
JOYDEEP MAJUMDER |
| Designation |
SCIENTIST E |
| Affiliation |
ICMR CENTRE FOR AGEING AND MENTAL HEALTH |
| Address |
ICMR CENTRE FOR AGEING AND MENTAL HEALTH
Department of Climate Change
Division of Mental Health
ROOM NO 3
BLOCK DP1
SECTOR V
SALTLAKE
ICMR CENTRE FOR AGEING AND MENTAL HEALTH
Department of Climate Change
Division of Mental Health
ROOM NO 3
BLOCK DP1
SECTOR V
SALTLAKE
Kolkata
WEST BENGAL
700091
India |
| Phone |
7874503436 |
| Fax |
|
| Email |
majumder.j@gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V Ramalingaswami Bhawan
PO Box No 4911
Ansari Nagar
New Delhi
Pin Code 110029
India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan
PO Box No 4911
Ansari Nagar
New Delhi
Pin Code 110029
India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR JOYDEEP MAJUMDER |
ICMR Centre for Ageing and Mental Health |
ICMR Centre for Ageing and Mental Health
Department of Climate Change
Division of Mental Health
ROOM NO 3
BLOCK DP1
SECTOR V
SALTLAKE
Pin Code 700091
Kolkata
WEST BENGAL |
7874503436
majumder.j@gov.in |
| Dr Pavithra Arunachaleeswaran |
Schizophrenia Research Foundation (I) |
Department of Youth Mental Health Division of YMH Room No 23
Ground Floor Schizophrenia Research Foundation (I) R/7A North
Main Road Anna Nagar West Extension
Chennai
TAMIL NADU
600101
India
Chennai
TAMIL NADU |
0442615397
pavithra@scarfindia.org |
| Dr Ushri Banerjee |
University College of Science Technology and Agriculture |
Dept of Applied Psychology
University of Calcutta
3rd floor Room no 3
92 APC Road
Kolkata 700009
Kolkata
WEST BENGAL |
9831244000
ushribanerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee of SCARF |
Approved |
| Institutional Ethical Committee for Biomedical and Health Research |
Approved |
| Institutional Ethics Committee ICMR Centre for Ageing and Mental Health |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The primary study participants for the study include adolescents in the age group of 13-15 years, living in Sundarbans delta, who will receive the life skill intervention training. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIMHANS life skill intervention module (3 months) |
The NIMHANS model of life skill education adapted the core WHO life skill domains to focus on health promotion using the life skill approach, in an Indian school setting (Problem solving, Critical thinking, Effective communication, Decision making, Creative thinking, Interpersonal relationship skills, Self-awareness, Empathy, Coping with Stress, Coping with emotions) |
| Comparator Agent |
No comparator (single arm pre-post design) (baseline at 0 month, endline after 3 months, follow up after 6 months) |
No comparator (single arm pre-post design) |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 13-15 yrs.
Children currently living in the Sundarbans delta region.
Children willing to participate in the study and whose parents are consenting to participate in the study.
|
|
| ExclusionCriteria |
| Details |
NIL (all paricipants matching the eligibility criteria will be included) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Composite primary outcome
Life skill levels (WHO-ACE-IQ
and LSSAA-SF)
Self-esteem (RSES)
Coping skills (BRCS)
Stress (PSS-14) |
At the end of 3 and 6 months, post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2025 |
| 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="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
|
Background: Chronic adversities predispose adolescents to ‘social vulnerability, delinquency, deprivation and violence’ which significantly affect their mental health. School-based curriculum has limited focus on skill development that improves psychosocial competence and resilience. Hence community oriented training on life skills based education can prepare youths to mitigate challenges of urban slums and disaster prone areas. Novelty: Present study focuses on vulnerable adolescents living in slum households or disaster prone areas. With an aim to provide locally adapted, sustained life skills education in the natural setting, through trained community representatives. Objectives: - To locally adapt the NIMHANS life skill intervention module ‘Empowering Adolescents with Life Skills for Psychosocial Competence’, to be delivered to adolescents facing chronic adversities in the urban slums of Kolkata and Chennai, and Sundarbans delta.
- To test the feasibility and outcome of the locally adapted life-skill intervention modules on life skill levels among adolescents in the study sites.
Methods: The study will be conducted in 2 phases. Phase I includes Adaptation and development of locally adapted life skill intervention module. The module will be adapted from the NIMHANS life skill intervention module focussing on the 10 core life skill domains as per WHO recommendations. Phase II includes intervention delivery at community sites and outcome assessment using a pre-post design. Expected Outcomes: - Development and sustained delivery of a brief locally adapted Life Skills Module
- Improvement of vulnerable adolescents in different life skill domains
|