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
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SLCTR Registration Number
SLCTR/2018/018
Date of Registration
The date of last modification
Aug 24, 2019
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 or 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)
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/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
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)
1.
Change of anxiety level determined by comparison of scores obtained for SCARED tool before and after the intervention |
[ At baseline, at end of intervention and 3 months following implementation of the intervention ] |
Secondary outcome(s)
1.
• 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 |
[ 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
Date of first enrollment
2019-05-13
Date of study completion
Recruitment status
Recruiting
Funding source
Self funded
Regulatory approvals
Status
Approved
Date of Approval
2018-02-14
Approval number
P/19/01/2018
Details of Ethics Review Committee
Name: | 5. 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
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
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