Home » Trials » SLCTR/2018/036
Effectiveness of a new educational module to improve behavioural problems among grade 10 students in Ampara Regional Director of Health Services area
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SLCTR Registration Number
SLCTR/2018/036
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effectiveness of a new educational module to improve behavioural problems among grade 10 students in Ampara Regional Director of Health Services area
Public Title of Trial
A non-randomized clinical trial to improve behavioural problems among grade 10 students in Ampara Regional Director of Health Services area.
Disease or Health Condition(s) Studied
Mental health of the students
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1219-8466
Any other number(s) assigned to the trial and issuing authority
P/102/03/2018 ERC,Facuty of Medicine, University of Kelaniya.
What is the research question being addressed?
Can the behavioural problems of the grade 10 students in Ampara Regional Director of Health Services area be reduced with life skills education?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Grade 10 classes from 1AB, 1c and type 2 schools in the Ampara RDHS area.
This is a quasi-experimental study.
Out of 4 educational zones in the Ampara RDHS area, schools of one zone will be selected for the intervention, and another zone for the control arm.
An education package on life skills will be delivered through the teachers to the students of grade 10. They will teach life skills for three periods in a week. A booster session will be done after one month of initiation.
A self-reading leaflet will be distributed on the first day of the intervention to the group.
Prior to this, the teachers will be trained on mental health of the students and how to teach application of life skills.
The control group will engage in routine academic activities.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Percentage of children having aggressive behavior in the classroom (Self – reported questionnaire on aggressive behavior will be used to assess this).This questionnaire will adopted from a previous thesis on violence among school children in Sri Lanka with the permission of the author. Reference (Wijeratne et al., 2014) Hindawi Publishing Corporation BioMed Research International Volume 2014, Article ID 563143, 11 pages http://dx.doi.org/10.1155/2014/563143 |
[ At base line, at the end of the intervention and three months after the implementation of the intervention ] |
|
2.
Percentage of children who enjoy a good relationship with their classmates (this self-reported Questionnaire will be developed by the principal investigator). |
[ At base line, at the end of the intervention and three months after the implementation of the intervention ] |
|
3.
Students knowledge on mental health (a self-reported questionnaire will be used to assess the knowledge on mental health. This questionnaire will be developed by the principal investigator based on the leaflets and power point presentation used in the intervention). |
[ At base line, at the end of the intervention and three months after the implementation of the intervention ] |
Secondary outcome(s)
|
1.
Improvement in school attendance of students 2. Academic improvement in three selected subjects. 3. Emotional and Behavioural problems of the students which will be assessed using Strengths and Difficulties Questionnaire (SDQ) student’s version (self-reported). This is a standard questionnaire used to screen the mental health of children and can be found in http://www.sdqinfo.com/py/sdqinfo/b0.py.It is commonly used in Sri Lanka. |
[ At base line, at the end of the intervention and three months after the implementation of the intervention. ] |
Target number/sample size
300 students for the intervention group and 300 for the control group
Countries of recruitment
Sri Lanka
Anticipated start date
2018-11-07
Anticipated end date
2019-02-07
Date of first enrollment
2019-01-03
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-04-10
Approval number
P/102/03/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
N H S Nadeeka
Medical officer
Nutrition Coordination Division, 7th floor, Public Health Complex, Elvitigala mawatha, Narahenpita.
Office-0112368320
Mobile-0773774722
Fax-0112368320
sajaninadeeka@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Applicable
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
