Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000346875
Ethics application status
Approved
Date submitted
29/01/2021
Date registered
26/03/2021
Date last updated
1/03/2022
Date data sharing statement initially provided
26/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
LEAP: Language, ENGAGE and Play. Understanding emotions and meeting challenges through play
Scientific title
LEAP: Language, ENGAGE and Play.Building self-regulation through Play in school age children
Secondary ID [1] 303299 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poor Self-regulation 320510 0
Executive function 320511 0
Attention problems 320900 0
Condition category
Condition code
Mental Health 318378 318378 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ENGAGE consists of a toolbox of teacher-led games 30 minutes each day for a term (8-9 weeks). The games are common games used in childhood and allow adaptation with increasing levels of complexity. They target:
• Thinking / cognitive self-regulation and memory (e.g., cups memory, sorting),
• Feeling / emotional self-regulation (e.g., relaxation), and
• Doing / behavioural self-regulation (musical statues, Simon says).

To gain the most from ENGAGE, and get the best outcomes for the tamariki, it is essential the games match the developmental, emotional, and cultural needs of the children. Whilst the games are ones commonly used in NZ, they are relatively Eurocentric. We are therefore specifically incorporating structured play aka. ‘games’, from Te Ao Maori and Pacific world views. A different range of cultural adaptations, themes, language, and constructs will then be available for different communities. The games will be adapted by a range of experts to incorporate intentional language, intentional motor planning, and cultural adaptations to develop LEAP: Language, ENGAGE and Play. Resultant games will be engaging, developmentally scaffolded, and culturally appropriate. The additional effect on self-regulation of the adaptations will then be tested in an intervention trial across the Manaiakalani group of schools.

The study is designed as an open cohort, parallel, non-randomised cluster intervention trial to examine the effects of intentional language, intentional motor skill and cultural adaptations in LEAP with the self-regulation skills in ENGAGE: a teacher-led whole of classroom play-based program to improve self-regulation. ENGAGE will be part of the usual classroom teaching across 10 The Manaiakalani Kahui ako schools in term 1 2021. Manaiakalani Kahui ako is one of the longest standing Communities of Learning (COL) in New Zealand.

Adaptations will occur during two multidisciplinary workshops. The adapted games: LEAP, will be implemented from term 2 in a subset of schools with the remaining schools continuing with ENGAGE. The effect of LEAP on self-regulation will be compared to the effect of ENGAGE.

Study setting
Multisite intervention in Manaiakalani COL in Tamaki area in Auckland: the suburbs of Glen Innes, Panmure Bridge and Point England. This is a multicultural community with significant socioeconomic disadvantage. 25% children are Ma¯ori, 65% Pacific (25% Tongan, 15% Samoan,10% Cook Island Ma¯ori and 5% Other Pacific) and 10% Other ethnicities. Participating schools include: Glen Innes, Glenbrae, Glen Taylor, Panmure Bridge, Point England, Ruapotaka, St Patricks, St Pius X, Tamaki, and Stonefields. The approximate size of each classroom is 25-30 students.

LEAP: ENGAGE adapted according to the language, motor skills and culture of the children with developmentally appropriate scaffolding.

Intentional Language: Adaptations will be guided by baseline assessments as well as the Welcome to School (WTS) projects which include comprehensive data on language and working memory. Assessments will be undertaken by an experienced paediatric speech language therapist (SLT).
Intentional motor skills: Gross motor skills are relative strengths for Tamaki children, but some have difficulty with motor planning and fine motor skills. This, in combination with difficulties with emotional regulation and impulse control, can result in disruptive behaviour. An occupational therapist (OT) will assess baseline skills and ensure LEAP scaffolds motor-skills and motor-planning in a developmentally appropriate way.
Cultural adaptations: The Manaiakalani kahui ako is a multicultural community with 90% of children identifying as Maori or Pacific. We are using the opportunity to consult cultural experts, specifically incorporating structured play aka. ‘games’, from Te Ao Maori and Pacific world views and integrating adaptations from cultural leads from the school communities e.g., using coconut shells instead of cups in the memory games, ensuring children lie with heads in the same direction acknowledging tikanga re feet not being placed next to another persons’ head.
Teacher adaptations: ENGAGE is adapted as required by teachers. We will incorporate adaptations and suggestions from teachers experienced with ENGAGE in new entrant classrooms to develop a new baseline of games.
LEAP will be part of classroom activities for two school term (approximately 20-24 weeks). At the end of the study, the best set of games will be recommended as the routine classroom activities for upcoming school terms.
Student attendance data will help us explore dose response to intervention. Principles will provide information about supplemental student learning and behaviour support.
Intervention allocation was based on school principal's decisions. Students in the LEAP arm of the study will be assessed by occupational therapist and speech language therapist. As a result, schools allocated to LEAP should have an empty room for these assessments.
There are two workshops planned for the study. The first one will be held at the end of the first school term. Teachers involved in the study, occupational therapists, speech language therapists, Physical therapists, Maori cultural advisors, and ENGAGE developers will attend a full-day workshop. This group will prioritise the students' areas of need and adapt the games accordingly.
Intervention code [1] 319601 0
Behaviour
Intervention code [2] 319602 0
Lifestyle
Intervention code [3] 319838 0
Treatment: Other
Comparator / control treatment
The comparator treatment is ENGAGE. ENGAGE consists of a toolbox of teacher-led games 30 minutes each day for a term (8-9 weeks). The games are common games used in childhood and allow adaptation with increasing levels of complexity. They target:
• Thinking / cognitive self-regulation and memory (e.g., cups memory, sorting),
• Feeling / emotional self-regulation (e.g., relaxation), and
• Doing / behavioural self-regulation (musical statues, Simon says).
Control group
Active

Outcomes
Primary outcome [1] 326351 0
Self-regulation measured by changes in The Behaviour Assessment System for Children-3 (BASC-3) scores for Hyperactivity, Attention Problems and Aggression on the parent and teacher-rated BASC-3.
Timepoint [1] 326351 0
Last week of term 2
Last week of term 3
Last week of term 4
Secondary outcome [1] 391127 0
Self-regulation measured by The Strengths and Difficulties Questionnaire (SDQ). Total and sub-scale scores on the teacher rated SDQ. Actual scores and proportion of children in each category: close to normal, slightly raised, high, very high (slightly low, low, very low for prosocial score).
Timepoint [1] 391127 0
Last week of term 2
Last week of term 3
Last week of term 4
Secondary outcome [2] 391130 0
Attendance data will be measured as a proxy to dose-response to intervention.
Timepoint [2] 391130 0
Last week of term 2
Last week of term 3
Last week of term 4
Secondary outcome [3] 391131 0
Reading comprehension: Reading levels, using Observation survey of early literacy achievement (6-year-net). Scores in print concepts, word knowledge and comprehension will be recorded for each participant.
Timepoint [3] 391131 0
Last week of term 2
Last week of term 3
Last week of term 4
Secondary outcome [4] 392303 0
Self-regulation measured by The Strengths and Difficulties Questionnaire (SDQ). Total and sub-scale scores on the parent rated SDQ. Actual scores and proportion of children in each category: close to normal, slightly raised, high, very high (slightly low, low, very low for prosocial score).
Timepoint [4] 392303 0
Last week of term 2
Last week of term 3
Last week of term 4
Secondary outcome [5] 392304 0
Teacher feedback and suggestions about improvements. Participating teachers will take part in workshops to redesign or modify the ENGAGE games and their feedbacks will be recorded during the workshop.
Timepoint [5] 392304 0
End of term 2 and 3

Eligibility
Key inclusion criteria
The principals from all primary schools in the Manaiakalani COL are continuing with ENGAGE as part of usual classroom pedagogy and have agreed the COL will participate in the trial: either ENGAGE or the adaptation of ENGAGE and subsequent implementation of LEAP. The eligible population is thus children in years 1 and 2 enrolled in the schools in the COL..
All children will participate as part of usual classroom pedagogy. Children with pre- and post- behaviour measures will be included in the cluster-specific analyses. Children whose parents decline consent to assessment will participate in the ENGAGE or LEAP as part of usual pedagogy but will not have assessments done or have their data included in the trial.
Minimum age
5 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil (except children whose parents decline consent). There will be no gender, racial/ethnic, language, or socioeconomic restrictions to participation in this study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be conducted with cluster-wide data. The baseline characteristics of the students and schools will be summarised by intervention group: number/proportion in each category for categorical variables and means/SDs, or medians/ranges/IQRs for non-normally distributed data continuous variables.

Primary outcome analysis
The primary outcome, the change in the high-level measure of self-regulation, will be summarised by Cluster as a mean/SD. The mean score will be compared between the clusters using a two-level random effects linear regression model. Results will be reported as a mean difference between groups together with a 95%CI and p-value.

Secondary analysis
Secondary outcomes will be summarised within clusters and compared across clusters using linear and logistic regression models adjusted for school.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2021
Actual
15/04/2021
Date of last participant enrolment
Anticipated
8/08/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
330
Accrual to date
79
Final
Recruitment outside Australia
Country [1] 23416 0
New Zealand
State/province [1] 23416 0
Auckland

Funding & Sponsors
Funding source category [1] 307714 0
Charities/Societies/Foundations
Name [1] 307714 0
A+ charitable trust
Country [1] 307714 0
New Zealand
Primary sponsor type
Individual
Name
Dr Alison Leversha
Address
Starship Community Level 6, Building 15 Greenlane Clinical Centre, Epsom, Auckland 1051
Country
New Zealand
Secondary sponsor category [1] 308415 0
None
Name [1] 308415 0
Address [1] 308415 0
Country [1] 308415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307745 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 307745 0
133 Molesworth Street, Thorndon, Wellington 6011
Ethics committee country [1] 307745 0
New Zealand
Date submitted for ethics approval [1] 307745 0
12/01/2021
Approval date [1] 307745 0
25/02/2021
Ethics approval number [1] 307745 0

Summary
Brief summary
The study seeks to adapt and test developmental games that were previously tested in the ‘ENGAGE’ trial to make them more appropriate for pre-schoolers. The games aim to improve self-regulation and language-learning, which in turn may improve long term health and social well-being. The study takes the form of an open-cohort, parallel, non-randomised cluster trial, involving 330 participants in New Zealand. Those participants will be 5 and 6-year-old children from Tamaki, who will participate with their parents’ consent. Participating schools have included the ENGAGE trial since 2020 in their usual classroom teaching to support the development of self-regulation skills in the children. Half of those schools will now move to the LEAP trial. All children will be exposed to the intervention, but data will only be collected from children of consenting adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108350 0
Dr Alison Leversha
Address 108350 0
Starship Community Level 6, Building 15 Greenlane Clinical Centre, Epsom, Auckland 1051
Country 108350 0
New Zealand
Phone 108350 0
+64 21629047
Fax 108350 0
Email 108350 0
[email protected]
Contact person for public queries
Name 108351 0
Dr Sharin Asadi
Address 108351 0
Starship Community Level 6, Building 15 Greenlane Clinical Centre, Epsom, Auckland 1051
Country 108351 0
New Zealand
Phone 108351 0
+64 2102602466
Fax 108351 0
Email 108351 0
[email protected]
Contact person for scientific queries
Name 108352 0
Dr Alison Leversha
Address 108352 0
Starship Community Level 6, Building 15 Greenlane Clinical Centre, Epsom, Auckland 1051
Country 108352 0
New Zealand
Phone 108352 0
+64 21629047
Fax 108352 0
Email 108352 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10395Study protocol    381323-(Uploaded-25-02-2021-17-50-10)-Study-related document.docx
10396Informed consent form    381323-(Uploaded-29-01-2021-14-07-12)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.