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CTRI Number  CTRI/2024/02/062260 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 19/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Psychosocial rehabilitation programme for social workers in North-East, India 
Scientific Title of Study   Adaptation & implementation of Rehabilitation Competency Framework (RCF) for social workers practicing in the North East, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rugozevou Khate 
Designation  Ph.D Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Psychiatric Social Work, MV.Govindaswamy Building, NIMHANS, Hosur road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  6909939309  
Fax    
Email  agono.ag@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Psychiatric Social Work, Dr MV.Govindaswamy Building, NIMHANS, Hosur road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rugozevou Khate 
Designation  Ph.D Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Psychiatric Social Work, MV.Govindaswamy Building, NIMHANS, Hosur road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  6909939309  
Fax    
Email  agono.ag@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences(NIMHANS), Bangalore, India 
 
Primary Sponsor  
Name  UGC JRF 
Address  UGC, NET Bureau, university of Delhi, South Campus, Benito Juarez, New Delhi - 110021 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
RUGOZEVOU KHATE  National Institute of Mental Health and Neuro Sciences  Department of Psychiatric Social Work, Room No. - 106, Dr. MV. Govindaswamy building Hosur road , Bengaluru 560029
Bangalore
KARNATAKA 		 6909939309

agono.ag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Mental Health and Neurosciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Psychosocial Rehabilitation Programme based on Rehabilitation Competency Framework by WHO  Psychosocial Rehabilitation for persons with mental disorders for a period of Six months.Component includes needs and asessment, understanding intervention based on environment, working within scope of praactice and competencies. 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Social Workers who have completed full time Master is Social Work degree from a UGC recognized University.
2.Social workers working in North East who are part of existing organisations working in health, mental health, disability sectors
3.Social Workers knowing English language
4. Social workers who are ready to provide psychosocial rehabilitation to their clientele
5.Social workers who will continue to work with person with mental disorders.
 
 
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 programme for person with mental disorder, competent social workers  Day 0, Day 60, Day 180 
 
Secondary Outcome  
Outcome  TimePoints 
Increased knowledge, attitude and practice, effective psychosocial intervention for person with mental disorders  Day 0, Day 60, Day 180 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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   Phase 3 
Date of First Enrollment (India)   01/05/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 -  Statistical Analysis Plan
    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 [agono.ag@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2027?
    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 aims to adapt and implement WHO’s Rehabilitation Competency Framework for Social Workers practicing psychosocial rehabilitation for persons with mental disorders in North- East, India. The study follows a mixed method design. The study would be conducted in three phases. 
The first phase is the needs assessment. The researcher will develop interview scchedule and gather information of the resources/ systems available and the stake holders involved in the psychosocial rehabilitation in North -East. Around 5-8 social workers to be interviewed who are working in health/mental health, disability and livelihood sectors in North East. 
The second phase is divided into two parts. The first part of the second phase to adapt the psychosocial rehabilitation programme for which the researcher will review the WHO’s RCF and other research related to RCF. The researcher will also review existing psychosocial rehabilitation programmes that are are being provided at NIMHANS and other mental health NGOs around India. Based on the review, a draft psychosocial rehabilitation programme will be developed and adapted based on the competencies and activities of rehabilitation as given by the WHO RCF.
 The second part which includes the consultative workshop using the Theory of Change approach , which will be followed by expert validation of the drafted psychosocial programme.
 The third phase of the study involves implementation of the psychosocial programme by training of socials workers and follow up after six months. The Social workers will be trained in batches of 7 for a period of 1 month which will be online mode. The structures programme will be 3 days in a week for a month and the rsearcher will handhold them in the next 6 months.Six months folow up with the social workers trained on psychosocial rehabilitation programme where Theory of Change will be used to identify the indicators. an interview schedule will be developed to understand the challenges anf successes achieved. Socia workers will be monitored online.A competency based checklist will be used to understand the social workers competencies at the end of six months. The feasibility of the programme will also be assessed using Bowen’s frameworl adapted to Theory of Change.
 
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