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Trial registered on ANZCTR

Registration number

ACTRN12622000364774

Ethics application status

Approved

Date submitted

21/02/2022

Date registered

1/03/2022

Date last updated

1/03/2022

Date data sharing statement initially provided

1/03/2022

Date results provided

1/03/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Adaption and implementation of the ENGAGE programme: teaching self-regulation through play within the early childhood curriculm

Scientific title

Adaption and implementation of the ENGAGE programme: teaching self-regulation through play within the early childhood curriculm

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

self-regulation

Condition category

Condition code

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The ENGAGE(Enhancing Neurobehavioural Gains with the Aid of Games and Exercise) programme was administered to preschol children within their early childhood education center. ENGAGE is a play-based intervention. The programme focuses on skill building by identifying areas of development, selecting games that utilise the target skills, and then systematically playing the games at increasingly challenging levels. Games are focused on the three areas of self-regulation (emotional regulation, cognitive regulation, and behavioural regulation). The focus of ENGAGE is on playing games that target the skills being developed, the games played are not prescribed although some examples are provided (e.g., puzzles, balls games, memory games, inhibitory games).
Participanting centres were recruited by the Auckland Kindergarten Association (AKA) who made face-to-face contact with all participating centres’ teachers to provide them with the broad research aims and programme information prior to them consenting to participate.
All participating centres underwent a 10-week wait-list control period where pre-post teacher ratings of children's self-regulation were collected to ascertain the degree to which self-regulaton scores change over this time period when participating in the early childhood education curriculum as usual.
Shortly before beginning the 10-week active ENGAGE intervention period of the study, teachers attended a 2 hour long training workshop run by accredited ENGAGE trainers who were also trained ECE teachers and support workers. Teachers were also provided with a programme manual outlining the programme philosophy, as well as step by step implementation information and lists of games to try. Teachers were asked to read through the relevent section in the manual each week before beginning the new week of games. There were new game ideas available for each of the first 5 weeks of the programme. After this, teachers could reuse any of the suggested games as well as any of their own games. Teachers were encouraged to introduce any other games that they knew and that involved the targeted skills (i.e., emotional, behavioural, and/or cognitive regulation).
The intervention involved teachers spending a minimum of 30 minutes a day exposing children to ENGAGE activities within a group format. Games were typically played at set times (often during morning or afternoon mat times). Some games were played within larger groups (e.g., 15 children) and some in smaller groups (e.g., 3-5 children), depending on the types of games being played. The games were typically run by 1 or 2 teachers at a time.
Once the intervention began the centres received regular check-in visits by the ENGAGE trainers/facilitators throughout the 10-week period, enabling frequent trouble shooting and discussion of any concerns.

Intervention code [1]

Behaviour

Comparator / control treatment

Waitlist control period (10 weeks)

Control group

Active

Outcomes

Primary outcome [1]

Behavioural self-regulation as measued by teacher ratings of Hyperactivity on the BASC-2,

Timepoint [1]

Within one week after completing the 10 week intervention.

Primary outcome [2]

Cognitive self-regulation as measured by teacher ratings of Attention Problems on the BASC-2

Timepoint [2]

Within one week after completing the 10 week intervention

Primary outcome [3]

Emotional self-regulation as measured by teacher ratings of Aggression on the BASC-2

Timepoint [3]

Within one week after completing the 10 week intervention

Secondary outcome [1]

Maintenance of treatment effects over time by repeated teacher ratings of Hyperactivity on the BASC-2

Timepoint [1]

2 and 6 months post-intervention

Secondary outcome [2]

Maintenance of treatment effects over time by repeated teacher ratings of Attention Problems on the BASC-2

Timepoint [2]

2 and 6 months post-intervention

Secondary outcome [3]

Maintenance of treatment effects over time by repeated teacher ratings of Aggression on the BASC-2

Timepoint [3]

2 and 6 months post-intervention

Eligibility

Key inclusion criteria

Early Childhood Education Centers (ECEs) were recruited within the Auckland region of New Zealand. This is the largest and most diverse region in the country and therefore enabled an ethnically and economically diverse group of centres to be recruited. Centres were contacted via already established connections with the Auckland Kindergarten Association (AKA).

Minimum age

3 Years

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Early Childhood Education Centres who had had prior exposure to the ENGAGE programme, or who were actively involved in other learning support interventions were precluded from participating

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

n/a

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

n/a

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

We assessed changes in scores for hyperactivity, aggression and attention problems across time using linear mixed model with random intercepts. For each outcome, models were estimated using data from (i) T1 to T3 for n=565 children with data across all three measurements; (ii) T1 to T4 for n=409 children with data across all four measurements; and (iii) T1 to T5 for n=114 children with data across all five measurements. T1 was the reference category in all models. Because models were restricted to children with data across all time points assessed, controls for time-invariant factors such as gender, age at first assessment, ethnicity, and early childhood centre were not necessary.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

5/03/2018

Date of last participant enrolment

Anticipated

Actual

7/05/2018

Date of last data collection

Anticipated

Actual

21/12/2018

Sample size

Target

700

Accrual to date

Final

668

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Tindall Foundation

Address [1]

PO Box 33 181, Takapuna, Auckland, 0740

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56, Dunedin, 9051

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago ethics committee

Ethics committee address [1]

PO Box 56, Dunedin, 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/05/2017

Approval date [1]

27/07/2017

Ethics approval number [1]

17/075.

Summary

Brief summary

Self-regulation is essential for successful human functioning across the lifespan. Difficulties in self-regulation early in life have been associated with a wide array of adverse outcomes including difficulties with school transition, educational attainment, and social functioning in childhood, as well as employment, mental health, physical health, relationships, and criminal activity in adulthood. ENGAGE (Enhancing Neurobehavioural Gains with the Aid of Games and Exercise) is a play-based intervention fostering the development of self-regulation in pre-schoolers and has led to improvements when used within the home setting. Given that most children attend some form of early childhood education setting, this is an ideal environment in which to teach self-regulation. The aim for this study was to ascertain whether ENGAGE can be implemented within an ECE group setting and whether this also leads to improved self-regulation. 668 children aged 3-5 years and their teachers, across 28 Early Childhood Education Centres (ECE) participated. Children’s self-regulation skills were assessed via scores on the Hyperactivity, Aggression, and Attention Problems subscales of BASC-2. Results indicted no significant changes in self-regulation skills across a 10-week waitlist period. Following 10 weeks of the ENGAGE programme, significant improvements in self-regulation were reported, and these were maintained at 2- and 6-month follow-up. These findings indicate that ENGAGE translates well into the ECE setting and has the potential to have population-based impacts on self-regulation abilities which could lead to more positive societal outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Dione Healey

Address

Department of Psychology
University of Otago
PO Box 56
Dunedin
9054

Country

New Zealand

Phone

+64 3 4797620

Fax

dione.healey@otago.ac.nz

Contact person for public queries

Name

Dione Healey

Address

Department of Psychology
University of Otago
PO Box 56
Dunedin
9054

Country

New Zealand

Phone

+64 3 4797620

Fax

dione.healey@otago.ac.nz

Contact person for scientific queries

Name

Dione Healey

Address

Department of Psychology
University of Otago
PO Box 56
Dunedin
9054

Country

New Zealand

Phone

+64 3 4797620

Fax

dione.healey@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Teacher ratings of Hyperactivity, Attention Problems, and Aggression on the BASC-2 across our 5 time points will be available on reasonable request. The data set will only include particpant IDs and no identifying information will be available

When will data be available (start and end dates)?

Upon reasonable request for 10 years from now until December 2032

Available to whom?

Researchers

Available for what types of analyses?

Meta analyses or other analyses deemed to be a reasonable use of the de-identified data

How or where can data be obtained?

Via request send to the primary contact (dione.healey@otago.ac.nz)

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Adaption and implementation of the engage programme within the early childhood curriculum.	2022	https://dx.doi.org/10.1038/s41598-022-25655-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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