| CTRI Number |
CTRI/2024/10/075419 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [LIFE SKILLS INTERVENTION] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A multisite study exploring the feasibility and immediate outcomes following a locally adapted life-skills intervention for adolescents experiencing chronic adversities |
|
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 |
Dr Pavithra Arunachaleeswaran |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation (I) |
| Address |
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 |
| Phone |
0442615397 |
| Fax |
|
| Email |
pavithra@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavithra Arunachaleeswaran |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation (I) |
| Address |
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 |
| Phone |
0442615397 |
| Fax |
|
| Email |
pavithra@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavithra Arunachaleeswaran |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation (I) |
| Address |
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 |
| Phone |
0442615397 |
| Fax |
|
| Email |
pavithra@scarfindia.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan PO BOX No 4811 Ansari Nagar New Delhi 110029 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| none |
not applicable |
|
|
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 nd Mental Health |
Department of Climate Change
Division of Mental Health
Room No 3
Block DP1
Sector V
Salt Lake
Kolkata
Kolkata
WEST BENGAL |
7874503436
majumder.j@gov.in |
| Pavithra Arunachaleeswaran |
Schizophrenia Research Foundation (I) |
Department of Youth Mental Health
Room No 23
Ground Floor
Division YMH
R/7A North Main Road
Anna Nagar West Extn
Chennai-600101
Chennai
TAMIL NADU |
0442615397
pavithra@scarfindia.org |
| Dr Ushri Baneerjee |
University college of Science Technology & Agriculture, University of Calcutta |
Department of Applied Psychology
3rd Floor
Room no.3
92, APC Road
University College of Science, Technology & Agriculture,
Kolkata-700019
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 |
| IEC ICMR CAM Kolkata |
Approved |
| Institution Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Life Skill Training |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Life Skills intervention (Co-developed) |
The intervention proposed to be delivered to the participants is a life skills training program which will be adapted from NIMHANS.
Psychosocial Competence’ manual
The life skill training will focus on 10 core areas as recommended by the WHO Life skills
the total duration of the intervention will be 3 - 6 months, delivered over 1 year of the intervention phase. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
The study participants for the intervention phase include children with the following eligibility criteria: 1) Children in the age group of 13-15 yrs 2) Children currently living in the urban slum community in Chennai or Kolkata or Sundarbans delta region. 3) Children willing to participate in the study and whose parents are consenting to participate in the study. |
|
| ExclusionCriteria |
| Details |
None in Particular
However, participants who fail to obtain parental consent to participate and are differently abled with intellectual disability may be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The improvement in life skills will be assessed using the life skill scale for adolescents and adults-short form (LSSAA- SF) |
three time points : Baseline , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self esteem (Rosenberg Self-esteem Scale), Coping (Brief Resilient Coping Scale) & Perceived Stress (Perceived Stress Scale) |
Baseline 0 month & subsequently, 3 months & 6 months post-intervention |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
03/02/2025 |
| 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)
|
Not Applicable |
| 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: 1. 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. 2. 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 the Adaptation and development of a 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: 1. Development and sustained delivery of a brief locally adapted Life Skills Module 2. Improvement of vulnerable adolescents in different life skill domains |