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CTRI Number  CTRI/2024/08/072803 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   Effect and experience of Safe Child Training Model (SCTM) on Knowledge, self-efficacy and reported outcomes regarding the prevention of child abuse among teachers  
Scientific Title of Study   Experience and effect of Safe Child Training Model (SCTM) on Knowledge, self-efficacy and reported outcomes regarding the prevention of child abuse among teachers from selected schools at Thrissur District. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bincy A P 
Designation  Associate Professor 
Affiliation  Kerala University Of Health Sciences, Thrissur 
Address  Amala college of Nursing,Thrissur
Ap Bhavan,Cheekkilode,Kozhikode
Kozhikode
KERALA
673315
India 
Phone  09495176818  
Fax    
Email  bincyap09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof.Dr .Rohini T 
Designation  Principal 
Affiliation  Kerala University Of Health Sciences, Thrissur 
Address  Institute of Nursing Sciences and Research Malabar Cancer Centre. Thalassery rohinit29@gmail.com Ph:8078927713

Kannur
KERALA
670103
India 
Phone  8078927713  
Fax    
Email  rohinit29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bincy A P 
Designation  Associate Professor 
Affiliation  Kerala University Of Health Sciences, Thrissur 
Address  Mental Health Nursing Department Amala college of Nursing, Thrissur Kerala,680555
Ap Bhavan,Cheekkilode,Kozhikode

KERALA
673315
India 
Phone  09495176818  
Fax    
Email  bincyap09@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Bincy A P 
Address  Amala college of Nursing, Thrissur,Kerala,India,680555  
Type of Sponsor  Other [self funded] 
 
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 
Bincy A P  selected schools at Thrissur District,Nirmala convent UP School,Ayyanthole.  Amala college of Nursing,Thrissur
Thrissur
KERALA 
09495176818

bincyap09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional human ethics committee marsleeva medcity ,Palai  Approved 
Institutional human ethics committee marsleeva medcity ,Palai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  prevention of child abuse 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Safe Child Training Model (SCTM)  Month 1,Day 1(Morning +Evening) 1.Pretest 2.Education 3.Teach child training 4.Teach parental training 5.Identify and reporting 6.Introduce abuse free club and practice diary 7.Practice session 8.Distributing practice manual Month 2,Day 2 1.Follow up session 2.Monitoring practice diary 3.Doubt clarification 4.Post test 1 Month 3,Day 3 1.Follow up session 2.Monitoring practice diary 3.Doubt clarification 4.Post test 2 Total duration :3moths Frequency of session:1complete session and two follow-up session(3 times)  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details 
1.Teachers who teach 1-7th classes in school
2.Teachers are male/female/transgender teachers
3.Teachers can understand, read and write English or Malayalam
4. teachers who teach in a mixed school
 
 
ExclusionCriteria 
Details  1.Teachers who are not a permanent employee 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary parameters are knowledge, self-efficacy and reported outcomes regarding prevention of child abuse among teachers before and after implementation of safe child training model intervention  3months 
 
Secondary Outcome  
Outcome  TimePoints 
The correlation between knowledge, self-efficacy & reported outcomes regarding prevention of child abuse among school teachers & the association of knowledge, self-efficacy & reported outcomes regarding prevention of child abuse with the selected baseline variables among schoolteachers.  6months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/09/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - NO
Brief Summary  

The study is a Mixed-Method study using Sequential explanatory design to determine the effect of Safe Child Training Model on knowledge, self-efficacy and reported outcomes regarding prevention of child abuse among school teachers from selected schools at Thrissur District. Baseline variable will be assessed using structured questionnaire. The knowledge, self-efficacy and reported outcome will be assessed using Structured Knowledge Questionnaire, Structured Teachers self-efficacy rating scale and Structured reported outcomes scale by convenience sampling. The Safe Child Training Model will be implemented to the subjects (in a group of 10 -15) in the experimental group over a period of 3 sessions. In the first month, one session will be given   lasting for two and half hours, succeeded by one follow up session each of one hours in the following two consecutive months. (Total 3months duration). After one month of implementing Safe Child Training Model, Post-test 1 will be conducted in both experimental and control group and again post-test 2 will be conducted after one month. The Safe Child Training Model will be implemented to the control group after completion of the study only One session will be given and there will be no follow up sessions. In qualitative data the experience of safe Child Training Model will be collected using semi structured interview guides in a one-on-one/face –to- face interview over a period of 30 to 45 minutes with the help of video recording. The primary outcome will be a significant change in the knowledge, self-efficacy and reported outcome among teachers  after implementing the safe child training model(Intervention).The secondary outcome is   the correlation between knowledge, self-efficacy and reported outcomes regarding prevention of child abuse among school teachers and  the association of knowledge, self-efficacy and reported outcomes regarding prevention of child abuse with the selected baseline  variables among school teachers.

 
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