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CTRI Number  CTRI/2019/02/017614 [Registered on: 12/02/2019] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Assessment of Nae Disha, a tool for building social and mental health resilience in young adults. 
Scientific Title of Study   Quantitative research - A randomized control trial of Nae-Disha (an intervention to promote psycho-social resilience) for children aged between 14-19 in Dehradun 
Trial Acronym  NDRSC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varadharajan Srinivasan 
Designation  Co-ordinator - Strategic Partnerships and Management Information Systems 
Affiliation  Emmanuel Hospital Association 
Address  Emmanuel Hospital Association, 808/92, Deepali Building, Nehru Place, New Delhi

South
DELHI
110019
India 
Phone  09560900978  
Fax    
Email  vardhus@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Varadharajan Srinivasan 
Designation  Co-ordinator - Strategic Partnerships and Management Information Systems 
Affiliation  Emmanuel Hospital Association 
Address  Emmanuel Hospital Association, 808/92, Deepali Building, Nehru Place, New Delhi

South
DELHI
110019
India 
Phone  09560900978  
Fax    
Email  vardhus@gmail.com  
 
Details of Contact Person
Public Query  
Name  Varadharajan Srinivasan 
Designation  Co-ordinator - Strategic Partnerships and Management Information Systems 
Affiliation  Emmanuel Hospital Association 
Address  Emmanuel Hospital Association, 808/92, Deepali Building, Nehru Place, New Delhi

South
DELHI
110019
India 
Phone  09560900978  
Fax    
Email  vardhus@gmail.com  
 
Source of Monetary or Material Support  
Grants set aside from local sources towards Mental health program by the organisation. Emmanuel Hospital Association, 808/92, Deepali Building, Nehru Place, New Delhi - 110019. 
 
Primary Sponsor  
Name  Emmanuel Hospital Association 
Address  808/92, Deepali Building, Nehru Place, New Delhi - 110019 
Type of Sponsor  Other [A society with interest in Social Sciences and Public Health Research] 
 
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 
Kaaren Mathias  Emmanuel Hospital Association  Project Burans, KHW, 193/1, Kath Bungalow, Rajpur Road, Dehradun - 248001
Dehradun
UTTARANCHAL 		 08755105391

kaaren@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Emmanuel Hospital Association  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Psycho-social resilience 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  A randomized control trial of   Children of age 14-19 from clusters identified in comparison slums in Dehradun 
Intervention  Nae-Disha  Nae-Disha is a 17 module intervention aimed at improving mental health resilience, social resilience and gender attitudes amongst youth. The children of age 14-19 from the clusters identified in the slums identified for the intervention. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  - Young people who reside in the selected cluster at least 4 nights per week
- 14-19 years of age on 1st of January 2019
- People with disabilities will be included
 
 
ExclusionCriteria 
Details  - Children who have already received the same intervention will be excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improved Social resilience  t0-baseline measures in cases and controls
t1-measures after intervention in cases and controls and
t2-six months from the end of intervention in cases
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in gender attitudes and improved mental health  t0-baseline measures in cases and controls
t1-measures after intervention in cases and controls and
t2-six months from the end of intervention in cases 
 
Target Sample Size   Total Sample Size="460"
Sample Size from India="460" 
Final Enrollment numbers achieved (Total)= "831"
Final Enrollment numbers achieved (India)="831" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2019 
Date of Study Completion (India) 30/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2020 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1.Mental health of young people: a global public-health challenge, Vikram Patel, Alan J Flisher, Sarah Hetrick, Patrick McGorry, 2.Kapungu C, Petroni S, Allen NB, Brumana L, Collins PY, Silva M De, et al. Comment Gendered influences on adolescent mental health in low-income and middle-income countries : recommendations from an expert convening. Lancet child Adolescent Heal [Internet]. 2017;4642(17):9–10. 3.Giovanelli A, Reynolds AJ, Mondi CF, et al. Adverse Childhood Experiences and Adult Well-Being in a Low income, Urban Cohort. Paediatrics. 2016;137(4) 4.Mathias, K., Pandey, A., Armstrong, G., Diksha, P., & Kermode, M. (2018). Outcomes of a brief mental health and resilience pilot intervention for young women in an urban slum in Dehradun, North India : a quasi-experimental study. International Journal of Mental Health Systems. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

One in five adolescents in the world face mental health problems and 50% of all those who develop mental health disorders develop them before they are 14. Gender inequality leads to both worse health outcomes and reduced resilience. Psycho social resilience is a developmental construct that could sustain adolescents’ health. Evidence suggests, that adolescents enrolled in interventions targeted at improving psychosocial interventions, improved performance in school and mental health in early adulthood.

“Nae Disha”, is a brief, peer led, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, Delhi. This tool was concluded to be effective to improve mental health resilience, mental health and gender equality attitudes among marginalised girls in an urban setting. This tool needs to be evaluated using a more robust methodology in urban setting for effectiveness amongst boys and girls from disadvantaged families.

 
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