CTRI Number	CTRI/2020/07/026834 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On:	27/07/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Preventive Screening Behavioral Other (Specify) [Psychological, Emotional, Social and Practical or Employment related strategies]
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	REaCHing to you with listening ears; A friendly telephonic interaction Program for the DDU-GKY members
Scientific Title of Study Modification(s)	“REaCH-Resiliency Engagement and Care in Health; A Telephone Befriending Intervention to address the Psycho-social challenges of vulnerable population in the context of COVID-19 Pandemic: An Exploratory Trial in India"
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Saju M D  Address  Rajagiri P.O Kalamassery Ernakulam KERALA 683104 India  Phone  9895346190   Fax     Email  saju@rajagiri.edu
Details Contact Person Scientific Query Modification(s)	Name  Dr Saju M D  Address  Rajagiri P.O Kalamassery Ernakulam KERALA 683104 India  Phone  9895346190   Fax     Email  saju@rajagiri.edu
Details Contact Person Public Query Modification(s)	Name  Dr Saju M D  Address  Rajagiri P.O Kalamassery Ernakulam KERALA 683104 India  Phone  9895346190   Fax     Email  saju@rajagiri.edu
Source of Monetary or Material Support Modification(s)	Rajagiri college of Social Sciences(Autonomous) Rajagiri P.O, Kalamassery, Cochin Pin: 683104  UK-India Education and Research Initiative funded by UGC and British Council UKIERI Fund address University Grants commission Bahadurshah Zafar Marg New Delhi- 110002 Project reference number - UGC-UKIERI- 2016-17-089, F. NO. 184-3/2017 (IC))
Primary Sponsor Modification(s)	Name  Director  Address  Rajagiri College of Social Sciences(Autonomous) Rajagiri P.O Kalamassery Kochi Kerala 683104  Type of Sponsor  Other [Educational Institution(Autonomous College)]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Saju M D  Rajagiri   ICRS, carmel block, 6th floor, opposite to college main library Rajagiri P.O Kalamassery Kochi Kerala Pin:683104 Ernakulam   9895346190 saju@rajagiri.edu
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Rajagiri Institutional Review Board  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Prevented or Screened
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  4 General Enquiry Phone calls  It will be a general inquiry about the precautions the participants are taking to protect themselves from the infection, and how the family is coping with the lockdown related issues. The most focus will be given on psycho-education based inquiries on COVID-19, etc.  Intervention  Assertive linkage with community resources  In this session the befriender will: — Provide practical support and information, — Emphasize on social support and strategies to improve it will be given, — Reassurance to the participant before termination of the session  Intervention  Proactive Engagement and Crisis Intervention  In this session the befriender will: — Establish a positive and supportive relationship with the participant, — Provide emotional support — Psycho-education about COVID-19 including precautionary measures, — Enquire about general health and biological functioning.  Intervention  Problem-solving oriented supportive therapy  This includes five general stages: — Problem orientation, problem definition and formulation, generation of alternatives, decision- making and verification.
Inclusion Criteria	Age From  18.00 Year(s) Age To  35.00 Year(s) Gender  Both  Details  1. Alumina students of the DDU-GKY program, who are either working or are in search of a job 2. Currently enrolled students in the DDU-GKY program 3. Students aged 18 and above 4. Own a smartphone?
ExclusionCriteria	Details  1. Do not own a smartphone 2. Unable to operate a smartphone 3. Less than 18 years of age
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Alternation
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome	Outcome  TimePoints  1. Mental wellbeing measured by World Health Organization-Five Well-being Index (WHO-5) 2. Depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) 3. Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS-12) (Zimet, Dahlem, Zimet & Farley, 1988)  4 weeks
Secondary Outcome	Outcome  TimePoints  Prevalence of mental health disorders in the population Increased wellbeing in the population More number of people with jobs among the target population   6 months
Target Sample Size	Total Sample Size="1480" Sample Size from India="1480"
Phase of Trial	N/A
Date of First Enrollment (India)	07/08/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="2" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	NIL
Brief Summary	The proposed trial is a telephonic intervention (Resiliency Engagement and Care in Health-REaCH)  that addresses the psycho-socio-economic challenges of vulnerable youth in the context of COVID-19 pandemic. This trial will have approximately 1480 participants across the 14 districts of Kerala, India. Later, the trial will then be executed in 28 states of India- Andra, Arunachal Pradesh, Assam, Bihar, Chattisgarh, Gujarat, Haryana, Himachal Pradesh, J&K, Jharkhand, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odhisa, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telengana, Tripura, Uttarakhand, Uttar Pradesh, West Bengal. The baseline assessment and follow-up assessment (after month one) will be done to measure outcomes- a) depression using PHQ-9, b) perceived social support using MSPSS and c) wellbeing using WHO-5. The intervention arm will receive- Proactive engagement, crisis intervention, problem solving and assertive linkages with community resources and control arm will receive four general enquiry calls.