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

25 Jun 2020

The date of last modification

Jun 26, 2020



Application Summary


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


Trial Details


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

  1. Inability to use a web application even with support due to physical or psychological disability
  2. Inability to comprehend written Sinhalese
  3. Schools without computer facilities for school students


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

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At baseline and 12 months from the start of the intervention

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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


Date of study completion


Recruitment status

Pending


Funding source

Templeton World Charity Foundation


Regulatory approvals

Ministry of Education



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)







Trial Completion details


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