Home » Trials » SLCTR/2018/018


Effectiveness of an intervention package to reduce anxiety among children aged 13-15 years attending Sinhala medium government schools in Colombo district: A Cluster Randomized trial -

SLCTR Registration Number

SLCTR/2018/018


Date of Registration

19 Jun 2018

The date of last modification

Jun 19, 2018



Application Summary


Scientific Title of Trial

Effectiveness of an intervention package to reduce anxiety among children aged 13-15 years attending Sinhala medium government schools in Colombo district: A Cluster Randomized trial


Public Title of Trial

Effectiveness of an intervention package to reduce anxiety among children aged 13-15 years attending Sinhala medium government schools in Colombo district: A Cluster Randomized trial


Disease of Health Condition(s) Studied

Mental Health


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1212-7722


Any other number(s) assigned to the trial and issuing authority

P/19/01/2018 (ERC: Kelaniya)


Trial Details


What is the research question being addressed?

Does an intervention package effectively reduce anxiety among children aged 13-15 years attending Sinhala medium government schools in Colombo district?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Prevention


Purpose


Intervention(s) planned

• One educational zone out of four educational zones in Colombo district will be selected as the study setting to carry out the study by drawing lots.

• Sinhala medium schools in the selected zone will be stratified according to the functional types; Class 1AB , 1C and type 2.

• 14 Schools will be selected and out of those schools, number of schools from each strata will be proportionately to the student population in each strata e.g. 1AB 40% - 6 schools 1C 30%-4 schools Type 2 30%- 4 Schools

• Stipulated number of schools for each stratum will be selected randomly.

• Schools in each strata will be randomized to study and control arm.

• From randomized each school two classes will be selected randomly from grade 8,9,10 (grades which has the study population)(Each class with 30 students)

• Teachers of the selected classes in the intervention arm will be trained to deliver the intervention package by a team which includes a consultant psychiatrist by conducting two half day training sessions on what is anxiety, how to identify anxiety and measures to reduce anxiety among children

Parents of the children in intervention arm will be educated simultaneously by using materials such as e.g. leaflets that will be developed by panel of experts after pre testing them

Intervention will be delivered as lecture discussion, role plays, relaxation exercises, home work It consists of 8 sessions (30 minutes per week for 8 week in a schedule agreed by school authorities in intervention arm )

All the selected classes(i.e. whole class/universally) of the randomized schools into intervention arm will receive the intervention at school setting in following order: 1. Introduction to feelings 2. The relationship between thoughts and feelings 3. Learning to cope with worries – emotional recognition, relaxation and how to feel good 4. Learning to cope with worries – challenging negative/unhelpful thoughts 5. Learning to cope with worries – challenging negative/unhelpful thoughts 6. Learning to cope with worries – developing problem solving skills 7. Learning to cope with worries – step plans and praising self for success 8. Review– recap on what learned and identify any potential problem

Control group- Routine services provided through National school health program i.e. health services provided by Medical Officer of Health via School Medical inspections (These services will not be withheld in schools included in intervention arm)


Inclusion criteria

• Children aged 13-15 years • Male and female • Attending Sinhala Medium government schools in Colombo district


Exclusion criteria

Those who have,
• Screen for Anxiety Related Disorders (SCARED) score above the cut off point for anxiety disorder prior to intervention

• Depression component [DASS-21] scores above the cutoff value for depression prior to intervention



Primary outcome(s)

Change of anxiety level determined by comparison of scores obtained for SCARED tool before and after the intervention


Primary outcome(s) - Time of assessment(s)

At baseline, at end of intervention and 3 months following implementation of the intervention


Secondary outcome

• Change of level of depression determined by scores obtained for DASS-21 Depression tool

• Change of level of self- esteem determined by ROSENBERG SELF-ESTEEM SCALE


Secondary outcome(s) - Time of assessment(s)

At baseline, at end of intervention and 3 months following implementation of intervention



Target number/sample size

840 (420 students/7 schools in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-09-10


Anticipated end date

2018-12-03


Recruitment status

Pending


State of ethics review approval

Approval has been obtained (Ref No:P/19/01/2018 (ERC: Kelaniya))


Funding source

Self funded



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. L.S.D De Silva
Registrar in Community Medicine
Department of Community Medicine Faculty of Medicine University of Colombo Colombo
0718021209
0776241994

sinha.dhanushka@gmail.com

Contact Person for Public Queries

Dr. Dulani Samaranayake
Consultant Community Physician/ Senior Lecturer,
Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo.
0112677765
0716613296

dulani_samaranayake@yahoo.com


Primary study sponsor/organization

Faculty of Medicine University of Colombo Colombo


0112 695 300


Secondary study sponsor (If any)

None