| 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
|
|
|
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
|
|
|
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
|
|
|
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. |