Early Minds: a pilot randomised controlled trial of a mindfulness program in early learning centres.

Background: Optimal mental health is critical for a child's learning and academic functioning. As a universal service, early education centres play an important role in promoting children's mental health. Social-emotional learning programs are efficacious in reducing behavioural difficulties, enhancing competence, and improving learning abilities. Mindfulness practices, known to promote health and wellbeing in adults, have been adapted to education programs for younger populations, including pre-school children. Despite an increasing use of mindfulness-based programs in pre-school settings, there is a limited number of randomised trials and paucity of data on implementation fidelity of these programs. 'Early Minds' is a mindfulness-based program developed by Smiling Mind for 3-5-year-old children. This paper describes a protocol of a pilot randomised control trial, evaluating the implementation of the program in early learning centres (ELCs, i.e. pre-schools) in Melbourne, Australia. The primary aim of this pilot study is to examine the feasibility, acceptability, and fidelity of the program. The secondary aims are to assess the acceptability of the design and measures and to investigate preliminary impacts of the program on child social-emotional outcomes.

Methods: A convenience sample of six ELCs are recruited. Participants include educators, children, and their parents from 3- and/or 4-year-old ELC rooms. Upon completion of baseline surveys, rooms are randomly allocated to intervention and control arms by an independent statistician. 'Early Minds' is designed in a flexible delivery manner; meditations and activities are completed at least three times a week. Educators are trained in the program and have access to the activities and meditations on an app. Parents are encouraged to practice with their children at least three times a week. Educators document implementation fidelity throughout the 8 weeks of the program. Parents and educators complete follow-up surveys at 3 and 12 months post-randomisation, capturing feasibility and acceptability, child social-emotional behaviour and sleep, and educator, parent, and family wellbeing outcomes.

Discussion: This pilot study is the first to assess a mindfulness-based program in ELCs in Australia. Data on feasibility and acceptability, implementation fidelity, and potential impact on children's behaviour will inform the design of adequately powered evaluation trials.

Trial Registration Number: Australian New Zealand Clinical Trials Registry, ACTRN12618000435280. Date registered 26 March 2018.