FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/093959 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Ecological Systems based Psychosocial Programme for High-Risk Adolescents.  
Scientific Title of Study   Feasibility of An Ecological Systems based Psychosocial Programme for High-Risk Adolescents.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Syeda Zoya 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Science (NIMHANS) 
Address  Department of Psychiatric Social Work, National Institute of Mental Health and Neuro Science (NIMHANS)

Bangalore
KARNATAKA
560029
India 
Phone  8240401996  
Fax    
Email  syedazoya9408@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Science (NIMHANS) 
Address  Department of Psychiatric Social Work, National Institute of Mental Health and Neuro Science (NIMHANS)

Bangalore
KARNATAKA
560029
India 
Phone  08026995230  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Syeda Zoya 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Science (NIMHANS) 
Address  Department of Psychiatric Social Work, National Institute of Mental Health and Neuro Science (NIMHANS)

Bangalore
KARNATAKA
560029
India 
Phone  8240401992  
Fax    
Email  syedazoya9408@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neuro Sciences (NIMHANS) Hosur Road, Bangalore 560029 
 
Primary Sponsor  
Name  Syeda Zoya 
Address  Department of Psychiatric Social Work, National Institute of Mental Health and Neuro Science (NIMHANS) Hosur road, Bangalore 560029 
Type of Sponsor  Other [Self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Syeda Zoya  National Institute of Mental Health and Neuro Sciences NIMHANS  Department of Psychiatric Social Work, Dr MV Govindaswamy Building, NIMHANS, Bengaluru 560029
Bangalore
KARNATAKA 		 8240401996

syedazoya9408@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  An Ecological Systems based Psychosocial Programme for High-Risk Adolescents  The Psychosocial Programme for High-Risk Adolescents will be developed and based on the Ecological Systems Model. The Programme will be provided over 12 weeks duration to each participant and will implement preventive and promotive interventions provided at micro, meso and macro levels to reflect the strengths of the adolescent at individual, family and community level.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Adolescents between the age of 13-17 years of age.
Adolescents able to communicate orally in Hindi or English.
Adolescents who show item endorsement on CABI, ICU-P and ASSIST.
Parents of adolescents should be concerned about the problematic behaviour or distress of the adolescent.
 
 
ExclusionCriteria 
Details  Adolescents with primary diagnosis of moderate/severe intellectual/ developmental disability.
Adolescents with a diagnosis of any Severe Mental Illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasibility will be assessed over a period of 6 months from the start to the end of the intervention in Phase2  6months 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life will be assessed at the two follow up timelines at the end of 3 months & 6 months post Intervention.   6months 
Resilience will be assessed at the two follow up timelines at the end of 3 months & 6 months post Intervention.   6months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/12/2025 
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="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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [syedazoya9408@gmail.com].

  6. For how long will this data be available start date provided 02-01-2028 and end date provided 31-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study is divided into two phases: Phase 1 will develop and validate the intervention ’An Ecological Systems-based Psychosocial Programme for High-Risk Adolescents’, and Phase 2 will check the feasibility of the intervention. The study employs a quasi-experimental pre- and post-test design with a single group. Mixed-method design. The primary outcome will be the feasibility of the intervention programme based on Bowen’s feasibility framework, and the secondary outcomes will be the quality of life and resilience which will be assessed at the end of 6 months of the study. 

 
Close