SLCTR Registration Number
Date of Registration
The date of last modification
Nov 05, 2018
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 of Health Condition(s) Studied
Mental health of the students
Universal Trial Number
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
Non-randomized controlled trial
Masking not used
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.
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
Percentage of children who enjoy a good relationship with their classmates (this self-reported Questionnaire will be developed by the principal investigator).
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).
Primary outcome(s) - Time of assessment(s)
At base line, at the end of the intervention and three months after the implementation of the intervention
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.
Secondary outcome(s) - Time of assessment(s)
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
Anticipated start date
Anticipated end date
State of ethics review approval
obtained approval from the Faculty of medicine ,University of Kelaniya on 10.04.2018.
Contact person for Scientific Queries/Principal Investigator
N H S Nadeeka
Nutrition Coordination Division, 7th floor, Public Health Complex, Elvitigala mawatha, Narahenpita.