| CTRI Number |
CTRI/2018/02/011765 [Registered on: 08/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to compare the effect of school based special type of teaching in reducing injuries among children of Dakshina Kannada district, Karnataka in compared to routine teaching. |
|
Scientific Title of Study
|
Effectiveness of school based interventions in promoting child safety and reducing childhood injuries in a District of Coastal South India – A Cluster Randomised Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramesh Holla |
| Designation |
Associate Professor |
| Affiliation |
KMC, Mangalore |
| Address |
Department of Community Medicine
Kasturba Medical College (MAHE), mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9741736093 |
| Fax |
|
| Email |
13rameshholla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Holla |
| Designation |
Associate Professor |
| Affiliation |
KMC, Mangalore |
| Address |
Department of Community Medicine
Kasturba Medical College (MAHE), mangalore
KARNATAKA
575001
India |
| Phone |
9741736093 |
| Fax |
|
| Email |
13rameshholla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh Holla |
| Designation |
Associate Professor |
| Affiliation |
KMC, Mangalore |
| Address |
Department of Community Medicine
Kasturba Medical College (MAHE), mangalore
KARNATAKA
575001
India |
| Phone |
9741736093 |
| Fax |
|
| Email |
13rameshholla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Reserach |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Reserach |
| Address |
Division of Reproductive and Child Health,
Indian Council of Medical Research Hqrs,
Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Ramesh Holla |
Kasturba Medical College |
Light House Hill Road
Mangalore 575001
Dakshina Kannada
KARNATAKA |
9741736093
13rameshholla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore, Manipal University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Questionnaire based study to assess the proportion of unintentional childhood injuries in the preceding 3 months of intervention arm and control arm schools |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Schools for regular modular teaching |
A training workshop was conducted by multidisciplinary healthcare professionals team to train the school teachers of intervention arm. Two teachers (including one Physical training/Sports teacher) from each school will be trained using a module created for this study. They were provided with instruction manual and reading and reference material to conduct the programme for their school children. Both the groups will complete the same questionnaires at baseline, and at three, six, nine and 11 months of the study. The students in the control arm would receive the comprehensive modular training programme after the end of final data collection (at the end of 11th months). |
| Comparator Agent |
Schools with modular teaching at the end |
Both the groups will complete the same questionnaires at baseline, and at three, six, nine and 11 months of the study. The students in the control arm would receive the comprehensive modular training programme after the end of final data collection (at the end of 11th months). |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
• Children attending class 5 to 7 in any of the schools selected for this study.
• Informed consent from the parent or guardian to participate in this study, and assent from the child.
|
|
| ExclusionCriteria |
| Details |
• Not available for end line survey after 11 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be assessed by determining the incidence of injury from the questionnaire which will be used at the baseline, and at the end of 3, 6, 9 and 11th month.
Operational definition of childhood injuries will be taken from the World Health Organization guidelines for conducting community surveys on injuries and violence.
|
Outcome will be assessed by determining the incidence of injury from the questionnaire which will be used at the baseline, and at the end of 3, 6, 9 and 11th month.
Operational definition of childhood injuries will be taken from the World Health Organization guidelines for conducting community surveys on injuries and violence.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="2214"
Sample Size from India="2214"
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)
|
27/06/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Need for the study: The
burden of communicable, infectious and nutritional disorders is gradually on
the decline due to massive efforts and investments by successive Indian
governments, simultaneously it is noticed that more and more children who have
escaped from infectious disease morbidity and mortality are becoming victims of
injury on road, at home and in public recreational places.Child safety promotion and injury prevention
requires combined, coordinated and sustainable effort from the various
ministries and departments. As the etiology of childhood injuries are diverse,
many interventions are need to be planned in an integrated way. As the child
spends considerable amount of time in school, targeting school children and
school teachers in promoting child safety and injury prevention strategy might
be a useful intervention. In US and other developed countries incidence of
childhood injuries reduced drastically after adopting necessary preventive
measures.Study Objectives
1)
To estimate the incidence of injuries among
school children and to assess the knowledge of school teachers in child safety
and injury prevention strategies.
2) To
design a comprehensive school based child safety and injury prevention module
3) To
evaluate the effect of comprehensive school based module on incidence of
childhood injuries. |