Plain English Summary
Background and study aims
Childhood is considered by many to be a time of happiness and being carefree, without the stress of bills to pay or job to keep. However, even very young children can have worries and may experience stress to some degree. This can be due to the demands of school or social activities, extracurricular activities and feeling worried about world events that they see on the news. Sahaja Yoga Meditation is a technique that can lead to better health and sense of well-being. It is said to help decrease stress and anxiety, strengthen the immune system and improve concentration, amongst other things. This study aims to provide children with meditation skills to better equip them to cope with stress and manage their emotions both at school and at home.
Who can participate?
Primary school aged children
What does the study involve?
Children are placed into one of three groups. Those in group 1 are taught Sahaja Yoga Meditation via face-to-face instruction in 20 minute sessions three times a week. Those in group 2 are taught Sahaja Yoga Meditation via video instruction in 5-10 minute sessions, 3-5 days a week. Those in group 3 are not taught Sahaja Yoga Meditation. The mental health of all children taking part is assessed by questionnaire at the start of the study and after 30 weeks.
What are the possible benefits and risks of participating?
The possible benefits of this study are that the child will learn a simple skill of reducing stress and improving emotional well-being that they can use regularly or at times when they are experiencing difficulty. It is hoped that by using this skill their long term risk of developing a mental health problem will be reduced. The researchers do not foresee any risks associated with taking part.
Where is the study run from?
Two primary schools in Australia.
When is the study starting and how long is it expected to run for?
October 2011 to December 2016
Who is funding the study?
Sydney University (Australia)
Who is the main contact?
Dr Ramesh Manocha
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Assessment of meditation for enhancement of mental health and well-being of school aged children
Acronym
Study hypothesis
Regular meditation delivered within the school environment enhances mental health and well-being of school aged children
Ethics approval
Sydney University Human Research Ethics Committee, 28/10/2011, ref: 14118
Study design
Multi-centre non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Schools
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
General well-being and mental health risk
Intervention
In this study, primary school children will participate in a controlled trial. They will be placed into one of three groups:
1. Face to face meditation instruction, based on sahaja yoga, delivered in class time (three times per week for ~20 minutes each time)
2. Video meditation instruction, based on sahaja yoga delivered in class time (three to five times per week for ~5-10 minutes each time)
3. No treatment (control)
Mental health will be assessed at baseline and after 30 weeks using the Strengths and Difficulties Questionnaire. The duration will be determined by each participating school, aiming for a minimum of one semester. Follow-up assessment is not anticipated due to practical challenges.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Changes in mental health, assessed using the Strengths and Difficulties Questionnaire at baseline and after 30 weeks
Secondary outcome measures
1. Drop out rates
2. Qualitative feedback regarding acceptability and feasibility of the intervention
Overall trial start date
28/10/2011
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Primary school aged children
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. No current/ previous history severe mental illness/disability
2. No condition that may prevent comprehension and engagement with behavioural intervention being studied
Recruitment start date
28/10/2011
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Australia
Trial participating centre
Ashfield Primary School
Sydney
2131
Australia
Trial participating centre
Toorak Primary School
Melbourne
3142
Australia
Funders
Funder type
University/education
Funder name
Sydney University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Peer-reviewed journals
Intention to publish date
01/01/2016
Participant level data
Stored in repository
Basic results (scientific)
Publication list