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CTRI Number  CTRI/2023/04/051899 [Registered on: 24/04/2023] Trial Registered Prospectively
Last Modified On: 23/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   implementation of WHO’s mobile based application in local language (Telugu) for behavioral and substance use disorders among children and adolescents. 
Scientific Title of Study   Feasibility study of implementation of WHO’s electronic mental health global action program - intervention guide (e-mhGAP-IG) by primary health care workers in delivery of mental health care for child and adolescent mental/behavioral disorders (CMH) and substance use disorders (SUB) in rural Andhra Pradesh., India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiranmayi Koni 
Designation  Professor 
Affiliation  Apollo College of Nursing, Chittoor 
Address  C/O Principal Apollo College of Nursing, Chittoor (ACONC), Apollo Institute of Medical Sciences and Research (AIMSR)

Chittoor
ANDHRA PRADESH
517127
India 
Phone  9441595671  
Fax  8572246666  
Email  kiranmayi_k@aimsrchittoor.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Kiranmayi Koni 
Designation  Professor 
Affiliation  Apollo College of Nursing, Chittoor 
Address  C/O Principal Apollo College of Nursing, Chittoor (ACONC), Apollo Institute of Medical Sciences and Research (AIMSR)

Chittoor
ANDHRA PRADESH
517127
India 
Phone  9441595671  
Fax  8572246666  
Email  kiranmayi_k@aimsrchittoor.edu.in  
 
Details of Contact Person
Public Query  
Name  Jayanthi Tarugu 
Designation  Professor 
Affiliation  The Apollo College of Nursing Chittoor 
Address  Apollo College of Nursing, Chittoor (ACONC), Apollo Institute of Medical Sciences and Research (AIMSR)

Chittoor
ANDHRA PRADESH
517127
India 
Phone  9440124768  
Fax    
Email  jayanthibhargav23@gmail.com  
 
Source of Monetary or Material Support  
Department of Health Research, ICMR 
 
Primary Sponsor  
Name  Department of Health Research, ICMR 
Address  Project Management and Implementation Unit (PMIU) Grant-in-Aid Scheme, Department of Health Research, Ministry of Health and Family Welfare, Government of India, New Delhi 
Type of Sponsor  Government funding agency 
 
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 
Kiranmayi koni  Apollo College of Nursing, Chittoor  Department of Nursing Apollo Institute of Medical Sciences and Research, Saketa Murakambattu,517127
Chittoor
ANDHRA PRADESH 		 9441595671
8572246666
kiranmayi_k@aimsrchittoor.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Apollo Institute of Medical Sciences and Research, Chittoor  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Substance abuse Childhood behavioral problems 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Paper based mhGAP intervention guide  -Training Primary Health Workers on adapting paper based mhGAP intervention guide for 1 week -After that once in 2 months Screening for prevalence of CMH and SUB using paper based mhGAP intervention guide 
Intervention  WHOs electronic mhGAP intervention guide in local language  -Training Primary Health Workers on adapting e-mhGAP intervention guide for 1 week -After that once in 2 months screening for prevalence of CMH and SUB using e- mhGAP intervention guide 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  -Primary health care centers (PHCs)/Sub centers within Chittoor district
-PHCs/Sub centers having at least one primary health care worker (PHW)
-PHWs having more than 1 year of experience at PHC/Sub-center
-PHWs having smartphones and those who can operate it 
 
ExclusionCriteria 
Details  -PHCs/Sub centers outside the Chittoor district
-PHCs/Sub centers having no PHWs
-PHWs having less than one year experience 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
- Prevalence of substance abuse among adolescents and behavioral problems among children
- Knowledge & practices towards CMH and substance use disorders
- Number of screenings, referral and psycho-educations and follow-ups
- Treatment outcome of CMH and substance use disorders
 		 - At base line
- 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 20th, 22nd, 24th month
 
 
Secondary Outcome  
Outcome  TimePoints 
Cost effectiveness of introducing MH GAP intervention guide and training at community in regional language  At endline 24th month 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/05/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published in any articles till now 
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 - Anyone

  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 - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (icmrplhvi2021@gmail.com).

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 31-05-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
NMHP intended to integrate mental health care into general health care to ensure provision to all needy. Non-specialist health care settings in rural India needs the technology like mh-GAP intervention guide to provision of mental health care to all needy which is the intent of WHO behind developing mh- GAP IG. This study aims to develop the mental health care service provision with the available resources though incorporating mh-GAP-IG technology which helps in easy provision of mental health care services at community health care settings.
 
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