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Clinical Trial Details (PDF Generation Date :- Tue, 05 Oct 2021 18:57:48 GMT)

CTRI Number CTRI/2019/03/018210 [Registered on: 20/03/2019] - Trial Registered Prospectively Last Modified On 19/03/2019 Post Graduate Thesis Yes Type of Trial Observational Type of Study Exploratory survey Study Design Other Public Title of Study Child abuse among children with special needs. Scientific Title of An exploratory survey to assess child abuse and its potential perpetrators among children with Study special needs in selected schools, , with a view to develop a public awareness programme on child abuse. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name JASNA T Trial Coordinator (multi-center study) Designation MPhil Nursing student Affiliation Manipal College of Nursing, Manipal Address Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi district Udupi KARNATAKA 576119 Phone 9495011096 Fax 911123232131 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name DRSHASHIDHARAYN Query) Designation Associate Professor and H O D Affiliation Manipal College of Nursing Address Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi district Udupi KARNATAKA 576119 India Phone 9886344627 Fax 911123232131 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Mr Jayakrishnan Designation District Project Officer SSA Affiliation District Project Office Address Sarva Shiksha Abhiyan District Project Office Door No 50/145 Akshajam East Kozhikode KERALA 673006 India

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Phone 04952361440 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi district Karnataka Primary Sponsor Primary Sponsor Details Name N A Address N A Type of Sponsor Other [No sponsor] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator MR STIVI BRC FEROK BLOCK PROGRAMME 9400785627 OFFICER, ROOM NO.1 GOVT UP SCHOOL, [email protected] PETTA FEROK Kozhikode KERALA MR MEHARALI BRC BLOCK PROGRAMME 9447535661 OFFICER ROOM NO.1, GOVT UP SCHOOL,TH [email protected] AMARASSERY Kozhikode KERALA MR SHIVADASAN BRC BLOCK PROGRAMME 9496896870 OFFICER, ROOM NO.1 GOVT UP SCHOOL, ssakunnamangalambrc MANASSERY @gmail.com MUKKOM Kozhikode KERALA MR AJAYAN BRC BLOCK PROGRAMME 9249786334 OFFICER, ROOM NO.1,GOVT UP [email protected] SCHOOL MAVOOR Kozhikode KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Kasturba Medical Approved 20/11/2018 No College and Kasturba Hospital Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers preventing child abuse among children with

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special needs Intervention / Type Name Details Comparator Agent Intervention Public awareness programme After the assessment of child on child abuse among children abuse among children with with special needs special needs, a public awareness programme will be conducted. Inclusion Criteria Inclusion Criteria Age From 8.00 Year(s) Age To 14.00 Year(s) Gender Both Details Both male and female children who are diagnosed as children with special needs aged between 8-14 years studying in either or English medium general schools in . Exclusion Criteria Exclusion Criteria Details Children who are not willing to participate and those who are absent. Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Assessment of child abuse among children with 13.03.2019 TO 19.11.2019 special needs Prevention of child abuse among children with special needs Secondary Outcome Outcome Timepoints NA NA Target Sample Size Total Sample Size=400 Sample Size from India=400 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 20/03/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NONE YET Brief Summary Child abuse is a global phenomena and children with special needs are more prone for being abused. This study is proposed to be conducted among children with special needs who are enrolled in either English or Malayalam medium schools of Kozhikode district aiming to assess the child abuse among them as well as to develop a public awareness programme to prevent child abuse.

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