Home » Trials » SLCTR/2019/018
Resilience among grade 10 adolescents in the Gampaha district: level, correlates and effectiveness of an intervention for its enhancement
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SLCTR Registration Number
SLCTR/2019/018
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
Resilience among grade 10 adolescents in the Gampaha district: level, correlates and effectiveness of an intervention for its enhancement
Public Title of Trial
A non randomized controlled school based community trial on the effectiveness of an intervention to enhance the ability to bouncing back to normal position after facing adversity among grade 10 adolescents in the Gampaha District
Disease or Health Condition(s) Studied
Resilience
Scientific Acronym
None
Public Acronym
None
Brief title
A school based community trial to enhance resilience among grade 10 students in the Gampaha district
Universal Trial Number
U1111-1230-8545
Any other number(s) assigned to the trial and issuing authority
p/205/12/2016 (ERC- University of Kelaniya)
What is the research question being addressed?
Does a psycho-therapeutic intervention improve resilience among grade 10 adolescents in the Gampaha district?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Single
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
The proposed intervention package consists of 10 sessions which will be held once in two weeks. Each session will be conducted over a duration of 30– 45 minutes. Students will be organized into small groups (n=20) for delivery of sessions.
The intervention will be implemented by two teachers and principal investigator. Training of the two teachers and PI will be done by a clinical psychologist and a educationist.
Intervention will be planned to do be done in two schools in the Gampaha District situated geographically far apart in order to reduce the effect of contamination. These two schools will be from the same stratum.
Control group will have 2-3 sessions of important health topic not related to resilience.
Initially the resilience level of grade 10 students will be assessed with a validated 14 item resilience scale both in the intervention and control arm. Two months after completion of the last session, post test will be conducted in both arms by administering of the 14 item resilience scale.
Inclusion criteria
Sinhala conversant adolescent children (both male and female) studying in grade 10 classes in intervention and comparison(control) schools in the Gampaha district
Exclusion criteria
Grade 10 students with physical and mental disabilities
Primary outcome(s)
|
1.
Enhancement of resilience in adolescent school children in grade 10 ( Defined as a 25% increase in the resilience score measured with the validated resilience scale) |
[ The resilience level will be assessed before commencement of intervention as well as two months after completion of intervention and enhancement of resilience will be assessed. ] |
Secondary outcome(s)
|
1.
Emotional and behavioural status – This will be measured with Strength and Difficulties Questionnaire self rated version(SDQ) which also has been validated in Sri Lanka(Perera H, 2004). |
[ The SDQ level will be assessed before commencement of intervention as well as two months after completion of intervention ] |
Target number/sample size
80 grade 10 students will be allocated for intervention arm and 80 for control arm
Countries of recruitment
Sri Lanka
Anticipated start date
2019-06-03
Anticipated end date
2019-12-02
Date of first enrollment
2019-05-16
Date of study completion
Recruitment status
Recruiting
Funding source
none
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-12-07
Approval number
P/205/12/2016
Details of Ethics Review Committee
| Name: | Ethics Revieww Committee, Faculty of Medicine, Kelaniya |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, Thalagolla Road, Ragama |
| Telephone: | 0112961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. D. M.S. Manori
Medical Officer
Anti Leprosy Campaign, Welisara
0112958658
0714 453186
manoridevagiri@yahoo.com
Contact Person for Public Queries
Dr.Pushpa Jayawardana
Formally, Professor in Public Health
Department of Public Health,
Faculty of Medicine,
University of Kelaniya.
0779400050
pushpaljayawardana@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
