Home » Trials » SLCTR/2020/016
LEAdership, Personal Growth, and Social Responsibility (LEAPS): A Character Development Intervention for Early Adolescents in Schools in Gampaha District: A Cluster Randomised Controlled Trial
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SLCTR Registration Number
SLCTR/2020/016
Date of Registration
The date of last modification
Oct 06, 2020
Scientific Title of Trial
LEAdership, Personal Growth, and Social Responsibility (LEAPS): A Character Development Intervention for Early Adolescents in Schools in Gampaha District: A Cluster Randomised Controlled Trial
Public Title of Trial
LEAdership, Personal Growth, and Social Responsibility (LEAPS): A Randomised controlled trial on a character development intervention for Adolescents in schools in the Gampaha district
Disease or Health Condition(s) Studied
Character
Scientific Acronym
LEAPS
Public Acronym
LEAPS
Brief title
LEAdership, Personal Growth, and Social Responsibility (LEAPS)
Universal Trial Number
U1111-1249-7113
Any other number(s) assigned to the trial and issuing authority
P/231/11/2019
What is the research question being addressed?
Could a culturally relevant web application build desirable character strengths in early adolescent school children in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
The stratified randomisation technique would be used for this cluster randomised controlled trial The stratum is decided according to the functional grading of schools by the Ministry of Education in Sri Lanka. Schools would be randomly picked until a total of 400 students are allocated from a stratum per group (1AB, 1C, type 2). The LEAPS web application would be implemented through an innovative e-platform. The students in the intervention group would go through 10 modules during their IT (information technology) periods, in addition to their allocated IT syllabus. The control group students would only go through their allocated IT syllabus as per all other school children of their age. Each module would comprise of a 40-minute activity once a month and the 10 modules would have to be completed over a 10-12-month period.
Inclusion criteria
A grade 7, 8 or 9 student of a Sinhala medium school in the District of Gampaha in Sri Lanka
Exclusion criteria
Primary outcome(s)
1.
Pre and post test assessment using 48 single best answer type questions targeting the six core virtues and 24 character strengths |
[ At baseline and 12 months from the start of the intervention ] |
Secondary outcome(s)
1.
None |
[] |
Target number/sample size
2400 in total
Countries of recruitment
Sri Lanka
Anticipated start date
2020-08-01
Anticipated end date
2022-07-31
Date of first enrollment
2020-09-01
Date of study completion
Recruitment status
Recruiting
Funding source
Templeton World Charity Foundation
Regulatory approvals
Ministry of Education
Status
Approved
Date of Approval
2020-02-11
Approval number
P/231/11/2019
Details of Ethics Review Committee
Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya |
Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
Telephone: | +94112961267 |
Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Miyuru Chandradasa
Senior Lecturer/Consultant Child and Adolescent Psychiatrist
Department of Psychiatry,
Faculty of Medicine,
University of Kelaniya,
P.O Box 6,
Thalagolla Road,
Ragama,
Sri Lanka
0112961000
0764628833
0112958337
miyuruc@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-miyuru-chandradasa.html
Contact Person for Public Queries
Professor Shehan Williams
Project Leader,
LEAPS Project,
Department of Psychiatry,
Faculty of Medicine,
University of Kelaniya,
P.O Box 6,
Thalagolla Road,
Ragama,
Sri Lanka
0112958039
0774301303
0112958337
leaps@kln.ac.lk
Primary study sponsor/organization
Templeton World Charity Foundation
Ellen Morgan,
Principal Advisor,
Templeton World Charity Foundation,Inc.,
P.O. Box N.7776,
Bayside Executive Park,
Building No. 2,
2nd Floor,
West Bay Street,
Nassau,
The Bahamas
+506 6222 8676
ellen@advisors.world
https://www.templetonworldcharity.org/who-we-are/external-advisors/ellen-morgan-mphil
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