Meditation for school children

ISRCTN	ISRCTN29529048
DOI	https://doi.org/10.1186/ISRCTN29529048
Secondary identifying numbers	1

Submission date: 04/07/2016
Registration date: 12/07/2016
Last edited: 11/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ramesh Manocha
Public

88 Wentworth Road
Burwood
2134
Australia

Study information

Study design	Multi-centre non-randomised interventional trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	School
Study type	Prevention
Participant information sheet	No participant information sheet available
Scientific title	Assessment of meditation for enhancement of mental health and well-being of school aged children
Study objectives	Regular meditation delivered within the school environment enhances mental health and well-being of school aged children
Ethics approval(s)	Sydney University Human Research Ethics Committee, 28/10/2011, ref: 14118
Health condition(s) or problem(s) studied	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
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 study start date	28/10/2011
Completion date	31/12/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Sex	Both
Target number of participants	200
Key inclusion criteria	Primary school aged children
Key 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
Date of first enrolment	28/10/2011
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Australia

Study participating centres

Ashfield Primary School

Sydney
2131
Australia

Toorak Primary School

Melbourne
3142
Australia

Sponsor information

Department of Psychiatry, Sydney University
University/education

Northern Clinical School
Royal North Shore Hospital
St Lenoards
2065
Australia

"ROR"	https://ror.org/0384j8v12

Funders

Funder type

University/education

Sydney University

No information available

Results and Publications

Intention to publish date	01/01/2016
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Peer-reviewed journals
IPD sharing plan