Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001342101
Ethics application status
Approved
Date submitted
17/09/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a rhythm and movement approach to improving preschool children's self-regulation
Scientific title
Effectiveness of a rhythm and movement intervention for preschool self-regulation development in disadvantaged communities: A clustered randomised controlled trial
Secondary ID [1] 299245 0
DE190101096
Universal Trial Number (UTN)
U1111-1240-0137
Trial acronym
RAMSR2020
Linked study record
Pilot study:
Williams, K.E., & Berthelsen, D. (2019). Implementation of a rhythm and movement intervention to support self-regulation skills of preschool-aged children in disadvantaged communities, Psychology of Music, doi: 10.1177/0305735619861433

Health condition
Health condition(s) or problem(s) studied:
Self-regulation 314387 0
Executive function 314559 0
Condition category
Condition code
Mental Health 312722 312722 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Rhythm and Movement for Self-Regulation (RAMSR)

RAMSR is a specific rhythm and movement intervention for young children that aims to support their attentional and emotional regulation skills, as well as mental flexibility, inhibition, and working memory (the executive functions). The intervention was designed by a team led by Kate Williams (Queensland University of Technology) who is a self-regulation researcher and Registered Music Therapist. The team also included a leading Neurologic Music Therapist, and an early childhood music specialist and educator. The intervention design draws on theory and evidence involving beat synchronization, cognitive benefits of formal music training, and music therapy for clinical populations. The theory and rationale for the intervention have been published (Williams, 2018).

The intervention is designed to be delivered by early childhood practitioners in a group setting with up to 25 children. The program has a series of four stages, with each stage consisting of four repeated sessions to make up the total of 16 sessions. Sessions are run twice per week meaning the program duration is 8 weeks in total.

Each of the four stages is represented by an activity session plan that group leaders use to implement the program. Accompanying the plans are a series of training and activity demonstration videos to support group leaders, all audio tracks required to run the activities, and visual cue cards needed for some activities. In addition, rhythm sticks, and animal castanets are required to implement the sessions.

All activities within the session plans are designed to practice key skills of attentional, emotional, and behavioral regulation, inhibition, shifting, and working memory through embedding these skills in coordinated movement activities enhanced by rhythmic auditory cueing. Common activity elements across the sessions included start/stop (inhibition), reversal of instruction (shifting, e.g., move in the silence and freeze in the music), working memory games, and beat synchronization to changing tempos. Original backing tracks provided rhythmic auditory cueing and leverage rhythmic entrainment principles
to stimulate more coordinated movement.

Within each session plan there are a series of sic activities with the above key elements
represented in each: (1) warm-up involving body percussion; (2) becoming familiar
involving an adaptation of a familiar early childhood song; (3) moving to the beat involving
large gross motor movements; (4) playing to the beat involving simple rhythm sticks or castanets; (5) dancing to the beat involving slightly more complex gross motor movement patterns to activity three of the session and often involving visual motor skills and coordination such as mirroring the shape of rhythm sticks on the floor with bodies; and (6) calming, which includes a series of movements and then stillness accompanied by relaxation music to support physiological entrainment to a calmer state that, targeting embodied emotional regulation.

In this trial RAMSR will be implemented in preschool settings by Bachelor degree qualified early childhood educators with groups of up to 22 children aged 3.5 to 4.5 years.
Intervention code [1] 315542 0
Behaviour
Intervention code [2] 315543 0
Prevention
Comparator / control treatment
The active control condition involves a once-off self-regulation webinar provided to educators in the control group. Children in the control group will receive their usual preschool program.
Control group
Active

Outcomes
Primary outcome [1] 321361 0
Emotional regulation, attentional regulation, and classroom regulation as measured through preschool and school teacher report on the Child Self-Regulation and Behavior Questionnaire (CSBQ) from the Early Years Toolbox for emotional and attentional regulation (Howard and Melhuish, 2015) and the Child Behaviour Rating Scale (CBRS) (Bronson, Tivnan, & Seppanen, 1995) for classroom self-regulation.
Timepoint [1] 321361 0
Baseline, 8 weeks (primary timepoint) and 12 months after intervention commencement.
Primary outcome [2] 321362 0
Executive functions of shifting, working memory, and inhibition as measured through three short iPad tasks from the Early Years Toolbox (Howard & Melhuish, 2015): Mr Ant; Go/No-Go; and Card-Sorting.
Timepoint [2] 321362 0
Baseline, 8 weeks (primary timepoint) and 12 months after intervention commencement.
Primary outcome [3] 321363 0
Behavioural self-regulation as measured through the Head Toes Knees Shoulders Task (Ponitz et al., 2009) and teacher report on the Child Self-Regulation and Behavior Questionnaire (CSBQ) from the Early Years Toolbox (Howard and Melhuish, 2015).
Timepoint [3] 321363 0
Baseline, 8 weeks (primary timepoint) and 12 months after intervention commencement.
Secondary outcome [1] 374765 0
School readiness as measured by the Bracken School Readiness Assessment—Third Edition which evaluates concepts essential to early communication development and school readiness (Bracken, 2007). The School Readiness Composite (SRC) comprises six subtests (colours, letters, numbers/counting, sizes, comparisons, and shapes) and assesses children’s knowledge of concepts traditionally taught to children in preparation for formal education.
Timepoint [1] 374765 0
Baseline, 8 weeks.
Secondary outcome [2] 374766 0
Behaviour problems as measured by the Strengths & Difficulties Questionnaire (SDQ) (Goodman, 2001) and reported by school teachers.
Timepoint [2] 374766 0
12 months after intervention commencement.
Secondary outcome [3] 374767 0
School transition and academic competency in relation to peers as reported by school teachers on four items adapted from the Longitudinal Study of Australian Children.
Timepoint [3] 374767 0
12 months after intervention commencement.
Secondary outcome [4] 374769 0
Educator knowledge, confidence, practice, and attitudes related to self-regulation and rhythm and movement activities as measured through survey items created by the investigator and also drawn from and adapted from Barrett et al. (2019).
Timepoint [4] 374769 0
Pre-training (baseline for educators), and 8 weeks after intervention commencement.
Secondary outcome [5] 374773 0
Fidelity of implementation of the intervention measured through post-session educator checklist on session plan adherence, adjustments, child responsiveness, and educator confidence.
Timepoint [5] 374773 0
Following each of the 16 intervention sessions.

Eligibility
Key inclusion criteria
Participants are educators in each of six early learning centres approached to participate, and all children enrolled in the kindergarten class in each centre.

To be eligible centres will:
1) Affiliate or branch member with large service provider and secondary sponsor of the trial, Creche and Kindergarten Association.
2) Be located within 70km from Brisbane, Australia CBD
2) Be in a low socioeconomic area as indicated by being in the top 3 deciles of SEIFA (most disadvantaged, deciles 1 to 3)
3) Be in a community area where 2018 Australian Early Development Census (AEDC) data indicates a higher than national average level of child vulnerability in both domains of social competence and emotional maturity.
4) Run a five-day fortnight kindergarten program with the same cohort of children attending at least 2 consecutive days per week
5) Have a teacher in the kindergarten program who is not planning to retire, resign, transfer, or take long service leave during the trial period in 2020 (as indicated on the expression of interest form).
6) Have a typically start-of-year enrolment of at least 80% of capacity (17 children).
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur at the centre level following recruitment of centres and the teachers within the centre, and collection of baseline teacher data. Assignment will occur at the centre level to avoid contamination, meaning across a whole centre teachers will all be either intervention teachers or control teachers. Teacher training will occur prior to the commencement of the 2020 kindergarten year and recruitment of children to the study. Thus, randomization must occur prior to child recruitment and baseline measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Directors at all eligible centres will be emailed trial information and invited to complete an expression of interest form which will collect information checking on eligibility items (including anticipated teacher employment stability). From those centres who complete an expression of interest form an independent researcher not involved in the study will randomly select the six centres, using stratification of enrolment numbers to ensure a balanced design, and will use a random number generator to allocate centres to intervention or control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Assessors working with children will be blind to group assignment.
Preschool educators reporting on child self-regulatory behaviours will not be blind to group assignment.
School teachers reporting on child outcomes at 12-month follow-up will be blind to group assignment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study estimates have been used for power and sample size calculations. Assuming a simple sampling design with no clustering, calculation in G*Power indicates a required sample size of 76 to detect small intervention effects with a power of 0.8 using the planned analytic approach (path analysis equivalent to multiple regression). The balanced cluster design of the RCT produces a design effect of up to 1.9, increasing the effective sample size to 144.

Using the 2016 pilot response rates at similar centres as a guide a sufficient final sample will be available as follows: 264 children invited to participate (100% of enrolment capacity in 6 centres); 237 families consenting (90%); 201 children completing data collection across two time points (15% attrition); 171 children completing data in Prep (additional 15% attrition).

The efficacy of the intervention will be evaluated within a structural equation modelling framework (using MPlus) with an intention-to-treat approach which will allow for: precision in the testing of intervention effects on the outcome measures across the intervention and control groups while controlling for Time 1 self-regulation scores and covariates; handling of missing data using full information maximum likelihood; and accounting for the clustered design (Kline, 2014). Path analysis (equivalent to multiple regression) will be used with effect sizes computed using formulas for independent-groups pre-post designs (for baseline and post-intervention scores) (Feingold, 2009). Latent curve modelling for pre-post-post designs can be used to examine intervention effects across baseline to post-intervention to follow-up (Mun, von Eye & White, 2009).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303782 0
Government body
Name [1] 303782 0
Australian Research Council
Country [1] 303782 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road
Kelvin Grove
Qld, Australia 4059
Country
Australia
Secondary sponsor category [1] 303911 0
Commercial sector/Industry
Name [1] 303911 0
Creche and Kindergarten Association
Address [1] 303911 0
257 Gympie Road, Kedron QLD 4031
Country [1] 303911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304303 0
Queensland University of Technology (QUT) Human Research Ethics Committee
Ethics committee address [1] 304303 0
Ethics committee country [1] 304303 0
Australia
Date submitted for ethics approval [1] 304303 0
24/06/2019
Approval date [1] 304303 0
08/08/2019
Ethics approval number [1] 304303 0
1900000566

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96458 0
A/Prof Kate Williams
Address 96458 0
Queensland University of Technology
Victoria Park Road
Kelvin Grove
Qld
Australia 4059
Country 96458 0
Australia
Phone 96458 0
+61 7 3138 3080
Fax 96458 0
Email 96458 0
[email protected]
Contact person for public queries
Name 96459 0
Kate Williams
Address 96459 0
Queensland University of Technology
Victoria Park Road
Kelvin Grove
Qld
Australia 4059
Country 96459 0
Australia
Phone 96459 0
+61 7 3138 3080
Fax 96459 0
Email 96459 0
[email protected]
Contact person for scientific queries
Name 96460 0
Kate Williams
Address 96460 0
Queensland University of Technology
Victoria Park Road
Kelvin Grove
Qld
Australia 4059
Country 96460 0
Australia
Phone 96460 0
+61 7 3138 3080
Fax 96460 0
Email 96460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The secondary sponsor currently has not provided approval for this data sharing, however, further negotiations will be undertaken to pursue this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378350-(Uploaded-17-12-2021-17-32-09)-Basic results summary.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRhythm and Movement for Self-Regulation (RAMSR) intervention for preschool self-regulation development in disadvantaged communities: a clustered randomised controlled trial study protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-036392
Dimensions AILatent Profiles of Teacher-Reported Self-Regulation and Assessed Executive Function in Low-Income Community Preschools: Relations With Motor, Social, and School Readiness Outcomes2021https://doi.org/10.3389/fpsyg.2021.708514
N.B. These documents automatically identified may not have been verified by the study sponsor.