Trial Review

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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] 306488 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
self-regulation 325350 0
Condition category
Condition code
Public Health 322732 322732 0 0
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] 322914 0
Behaviour
Comparator / control treatment
Waitlist control period (10 weeks)
Control group
Active

Outcomes
Primary outcome [1] 330537 0
Behavioural self-regulation as measued by teacher ratings of Hyperactivity on the BASC-2,
Timepoint [1] 330537 0
Within one week after completing the 10 week intervention.
Primary outcome [2] 330563 0
Cognitive self-regulation as measured by teacher ratings of Attention Problems on the BASC-2
Timepoint [2] 330563 0
Within one week after completing the 10 week intervention
Primary outcome [3] 330564 0
Emotional self-regulation as measured by teacher ratings of Aggression on the BASC-2
Timepoint [3] 330564 0
Within one week after completing the 10 week intervention
Secondary outcome [1] 406542 0
Maintenance of treatment effects over time by repeated teacher ratings of Hyperactivity on the BASC-2
Timepoint [1] 406542 0
2 and 6 months post-intervention
Secondary outcome [2] 406689 0
Maintenance of treatment effects over time by repeated teacher ratings of Attention Problems on the BASC-2
Timepoint [2] 406689 0
2 and 6 months post-intervention
Secondary outcome [3] 406690 0
Maintenance of treatment effects over time by repeated teacher ratings of Aggression on the BASC-2
Timepoint [3] 406690 0
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] 24592 0
New Zealand
State/province [1] 24592 0
Auckland

Funding & Sponsors
Funding source category [1] 310834 0
Charities/Societies/Foundations
Name [1] 310834 0
Tindall Foundation
Country [1] 310834 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56, Dunedin, 9051
Country
New Zealand
Secondary sponsor category [1] 312087 0
None
Name [1] 312087 0
Address [1] 312087 0
Country [1] 312087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310398 0
University of Otago ethics committee
Ethics committee address [1] 310398 0
Ethics committee country [1] 310398 0
New Zealand
Date submitted for ethics approval [1] 310398 0
22/05/2017
Approval date [1] 310398 0
27/07/2017
Ethics approval number [1] 310398 0
17/075.

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

Contacts
Principal investigator
Name 117522 0
A/Prof Dione Healey
Address 117522 0
Department of Psychology
University of Otago
PO Box 56
Dunedin
9054
Country 117522 0
New Zealand
Phone 117522 0
+64 3 4797620
Fax 117522 0
Email 117522 0
[email protected]
Contact person for public queries
Name 117523 0
Dione Healey
Address 117523 0
Department of Psychology
University of Otago
PO Box 56
Dunedin
9054
Country 117523 0
New Zealand
Phone 117523 0
+64 3 4797620
Fax 117523 0
Email 117523 0
[email protected]
Contact person for scientific queries
Name 117524 0
Dione Healey
Address 117524 0
Department of Psychology
University of Otago
PO Box 56
Dunedin
9054
Country 117524 0
New Zealand
Phone 117524 0
+64 3 4797620
Fax 117524 0
Email 117524 0
[email protected]

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 ([email protected])


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
SourceTitleYear of PublicationDOI
EmbaseAdaption and implementation of the engage programme within the early childhood curriculum.2022https://dx.doi.org/10.1038/s41598-022-25655-8
N.B. These documents automatically identified may not have been verified by the study sponsor.