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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

poor Self-regulation

Executive function

Attention problems

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]