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CTRI Number  CTRI/2022/06/043350 [Registered on: 20/06/2022] Trial Registered Prospectively
Last Modified On: 20/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Development of Psychosocial Rehabilitation Curriculum  
Scientific Title of Study   Development of a Psychosocial Rehabilitation Curriculum Based on the Rehabilitation Competency Framework (RCF) of World Health Organization (WHO) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India 
Address  Room No. 106, Govindaswamy Building, Department of Psychiatric Social Work, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India 
Address  Room No. 106, Govindaswamy Building, Department of Psychiatric Social Work, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ansur Farooq Khan 
Designation  MPhil Research Scholar 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India 
Address  Room No. 106, Govindaswamy Building, Department of Psychiatric Social Work, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  8713816565  
Fax    
Email  khanansurfeb2011@gmail.com  
 
Source of Monetary or Material Support  
Non-funded part of M.Phil dissertation 
 
Primary Sponsor  
Name  Ansur Farooq Khan 
Address  Govindaswamy Building, Department of Psychiatric Social Work, NIMHANS, Bengaluru, Karnataka, India 
Type of Sponsor  Other [Self Sponsored] 
 
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 
Dr Aarti Jagannathan  National Institute of Mental Health and Neurosciences (NIMHANS)  Department of Psychiatric Social Work, No:106, 1st Floor, Dr M V Govindswamy Memorial Centre, NIMHANS
Bangalore
KARNATAKA 		 9448150690

jaganaarti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Department of Psychiatric Social Work  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers - Mental Health and Psychosocial Rehabilitation Professionals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. The professionals including academicians and/or clinicians who possess requisite education & training to deliver Psychosocial Rehabilitation services.
2. The professionals who possess requisite experience in the field of psychosocial rehabilitation.
3. Researchers in the field of Psychosocial Rehabilitation. 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Psychosocial Rehabilitation Curriculum for Indian Context  Six Months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   20/06/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 18-04-2022 and end date provided 18-01-2026?
    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 Rehabilitation Competency Framework (RCF) - developed by the World Health Organization (WHO) - is completely a new framework for the rehabilitation workforce across the world. Since the RCF demands to be adopted & adapted into the various cultural contexts & rehabilitation settings; the researcher, therefore, have thought of bringing the RCF into the Indian Context with the aim of developing a Psychosocial Rehabilitation Curriculum based upon the RCF. To pursue the study, the researcher have set certain preliminary objectives such as: 1. To review the Rehabilitation Competency Framework (RCF) and understand case studies of how RCF is implemented in other countries. 2. To review and compare the Psychosocial Rehabilitation curricula available in India with that of WHO-RCF. 3. To develop and validate the Psychosocial Rehabilitation Curriculum developed/redesigned based on WHO-RCF with Rehabilitation and Mental Health Experts. 4. To provide recommendations for implementation of the Psychosocial Rehabilitation Curriculum based on WHO-RCF. In terms of the study design, the present research will have a qualitative exploratory study design with inductive method of enquiry as the study is going to make a curriculum based on RCF. In the initial phase, the researcher would gather the information in terms of reviewing the existing literature on rehabilitation and RCF followed with phase II which will focus on individual interviews / FGDs of experts in the same field for development and validation of the curriculum. For the present study, the sample of 5-10 Mental Health and Psychosocial Rehabilitation Professionals would be selected for each of the phase of the development and validation of the curriculum based on RCF till data saturation. The Inclusion Criteria has been set with the following considerations: 1. The professionals including academicians and/or clinicians who possess requisite education & training to deliver Psychosocial Rehabilitation services. 2. The professionals who possess requisite experience in the field of psychosocial rehabilitation. 3. Researchers in the field of Psychosocial Rehabilitation. With respect to the tools of data collection, the researcher will have three major tools such as a) Socio-demographic data sheet (Experts) b) Interview Schedule and c) Validation Checklist. The process of the study will be as under: Phase 1: Review of Literature (Part A + Part B), Phase 2: Development and Validation of Curriculum , Phase 3: Validation of Curriculum, Phase 4: Data Analysis, Phase 5: Development of Guidelines for Implementation. The researcher, after getting the content from primary sources as well as secondary sources, will analyze the data using Content Validation Ration (CVR) by Lawshe et al. The qualitative data will be subjected to manual qualitative content analysis.

 
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