Condition category
Mental and Behavioural Disorders
Date applied
04/07/2016
Date assigned
12/07/2016
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Dr Ramesh Manocha

ORCID ID

Contact details

88 Wentworth Road
Burwood
2134
Australia

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 measures

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

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

Sponsor information

Organisation

Department of Psychiatry, Sydney University

Sponsor details

Northern Clinical School
Royal North Shore Hospital
St Lenoards
2065
Australia

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes