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 -

SLCTR Registration Number

SLCTR/2018/036


Date of Registration

04 Nov 2018

The date of last modification

Nov 05, 2018



Application Summary


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


Scientific Acronym


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.


Trial Details


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


Assignment

Parallel


Purpose

Prevention


Purpose


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

  1. Males and females who are students of grade 10
  2. Been a student in the school for the past 6 months.

Exclusion criteria

  1. Students of grade 10 who have been enrolled for less than 6 months in that school


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

  2. Percentage of children who enjoy a good relationship with their classmates (this self-reported Questionnaire will be developed by the principal investigator).

  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).


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


Secondary outcome

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

Sri Lanka


Anticipated start date

2018-11-07


Anticipated end date

2019-02-07


Recruitment status

Pending


State of ethics review approval

obtained approval from the Faculty of medicine ,University of Kelaniya on 10.04.2018.


Funding source

Non



Contact & Sponsor Information


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

Contact Person for Public Queries

Prof Kumudu Wijewardena
Professor in Community Medicine
Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda.
Office-0112803191

Fax-0112801480


Primary study sponsor/organization

Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda

Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda



Secondary study sponsor (If any)

N/A