Home » Trials » SLCTR/2019/018


Resilience among grade 10 adolescents in the Gampaha district: level, correlates and effectiveness of an intervention for its enhancement

-

SLCTR Registration Number

SLCTR/2019/018


Date of Registration

14 May 2019

The date of last modification

May 14, 2019



Application Summary


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)


Trial Details


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


Date of study completion


Recruitment status

Pending


Funding source

none


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





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