Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000845831
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
1/07/2021
Date last updated
27/10/2023
Date data sharing statement initially provided
1/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kia Timata Pai (Best Start): The effect of teacher-child interactions on young children's oral language and self-regulation
Scientific title
Kia Timata Pai (Best Start): A cluster randomised trial with early childhood teachers to support children's oral language and self-regulation development
Secondary ID [1] 304018 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-regulation 321642 0
Oral language 321643 0
Condition category
Condition code
Mental Health 319382 319382 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to conduct a cluster randomised controlled trial (RCT)
to evaluate two evidence-based programmes — ENRICH (Enhancing Rich Conversations)
and ENGAGE (Enhancing Neurocognitive Growth with the Aid of Games and Exercise) — to support children’s oral language and self-regulation skills in the early childhood years. Through professional development with teachers, we will begin when children are age 1.5 years and follow them to age 6 years. ENRICH is conversation and book-based to foster toddlers' and preschoolers' oral language skills; ENGAGE is games-based to foster preschool children’s self-regulation skills. We will evaluate the effectiveness of targeting oral language alone (ENRICH) versus self-regulation alone (ENGAGE) versus a combined oral language and self-regulation arm (ENRICH + ENGAGE) relative to an active control group (curriculum as usual + child development webinars).

The four arms are thus (anticipating 400 children in each):
1) Language only: ENRICH (1.5 to 3 years) plus ENRICH+ (3 to 5 years)
2) Self-regulation only: ENGAGE (3 to 5 years)
3) Combined: ENRICH (1.5 to 3 years) plus ENRICH+ (3 to 5 years) plus ENGAGE (3 to 5 years)
4) Active control: Curriculum as usual + child development webinars

ENRICH and ENGAGE will be delivered using a "train the trainer" model in which investigators and trained facilitators with at least 10 years of experience in early childhood education will train professional practice leaders in the BestStart early childhood organisation in small face-to-face or online workshops. Professional practice leaders will receive a 2-day training workshop in the conversational techniques (ENRICH) when children are 1.5 years old on average, and a separate 1-day training workshop in the advanced conversational techniques (ENRICH+) and/or games (ENGAGE) when study children are 3 years old. In between workshops, professional practice leaders will receive booster training sessions every 9 months via face-to-face or video training to explain the new resources and how to use them. The mode of training at workshops will be via background information sessions, interactive activities, and short videos for a total of 12 hours across 2 days at the start of the study at age 1.5 years, a total of 12 hours across 2 days at age 3 years for the combined ENRICH + ENGAGE group, and a total of 6 hours in one day at age 3 years for the ENRICH-only group and for the ENGAGE-only group. The booster training sessions in between workshops will occur every 9 months (at age 2.25, 3.75, and 4.5 years) and will be 2 hours each. Professional practice leaders, all of whom are qualified early childhood educators with at least 10 years of experience in the field, will then train the early childhood teachers in small face-to-face or online groups. Teachers will then use the new techniques with the children in their care. Teachers in the intervention arms will receive new resources (a set of cards specially designed for this study with tips for interactions and games) and new books every 6-9 months. The books will be commercially available, but will contain conversation prompts on each page that have been specially designed for this study. Teachers in intervention arms will invite parents at their centres to learn about the new techniques through information evenings and video links. The intervention will take place in early childhood classrooms on a daily basis from when study children are aged 1.5 to 5 years for ENRICH, and from age 3 to 5 years for ENGAGE. Teachers will be encouraged to use the ENRICH activities at their discretion throughout the day during five routines: mealtimes, nappy changes/clean-up time, book-reading time, free-play time, and group time. Teachers will be encouraged to use the ENGAGE games for up to 30 minutes each day.

The ENGAGE-only arm of the intervention will receive the same webinars (on childhood nutrition) as the active control group for the first 1.5 years of the study before the intervention begins at age 3 years. The active control group will continue to receive webinars (on children's friendships) during the preschool phase of the study from ages 3 to 5.

Intervention fidelity will be measured in two ways: 1) via teacher self-ratings of the frequency and quality of their delivery of the techniques with individual children on a fortnightly basis; and 2) via videotaped teacher-child interactions in the classrooms once a year on a subset of 24 participating centres, 6 from each arm. Teachers will be provided with feedback on their use of the techniques to maintain and improve fidelity.

The trial represents a partnership between BestStart Educare, an external implementation service (Methodist Mission Southern), and a consortium of academics (Emotion Regulation Aotearoa/New Zealand) to provide a culturally responsive intervention with codesigned implementation. This research-informed and collaborative approach entails engaging with our research partners prior to each wave of data collection and teacher training. We provide our partners with the opportunity to review proposed measures and procedures. This approach may lead to adjustments over time in response to partner feedback (e.g., response burden of measures or timeline for assessments) or in response to emerging research evidence.
Intervention code [1] 320328 0
Prevention
Intervention code [2] 320329 0
Behaviour
Comparator / control treatment
Teachers in the active control group will carry on with the BestStart curriculum as usual. They will also receive webinars on child development topics delivered by child development experts, either by the investigators themselves, or by other Ph.D.-level researchers in New Zealand who are experts on the topic. Each webinar will last for approximately 30 minutes with time for questions for a total of 1 hour. These webinars will occur every 9 months from age 1.5 to 5 years, in parallel with delivery of new resources to the intervention groups. These webinars will be on topics that are not directly related to oral language or self-regulation (e.g., nutrition and friendships). Parents of children in the active control group will be invited to attend these webinars or to watch recordings.
Control group
Active

Outcomes
Primary outcome [1] 327246 0
Self-regulation will be assessed through the teacher-report version of the Early Childhood Behaviour Questionnaire (ECBQ) in the toddler phase (ages 1.5 and 2.25 years), and with the teacher-report version of the Childhood Behavior Rating Scales (CBRS) in the preschool phase (ages 3 to 5 years) and after school entry (age 6).
Timepoint [1] 327246 0
Baseline, and at 9, 18, 27, 36, 42, and 54 months post-intervention commencement
Primary outcome [2] 327247 0
Oral language will be assessed by age-appropriate teacher-report versions of the New Zealand Communicative Development Inventories (NZ CDI short forms in English and te reo Maori) in the toddler phase (ages 1.5 and 2.25 years), and with the Teacher Report on Oral Language and Literacy (TROLL) in the preschool phase (ages 3 to 5 years) and one year after school entry (age 6). Children's oral language in te reo Maori will be assessed in the preschool phase and one year after school entry with teacher-report checklists of phrases and sentences.
Timepoint [2] 327247 0
Baseline, and at 9, 18, 27, 36, 42, and 54 months post-intervention commencement
Primary outcome [3] 327248 0
Advanced language (expressive and receptive) and early literacy (phonological awareness and letter recognition) will be assessed by the Preschool Early Literacy Indicators (PELI).
Timepoint [3] 327248 0
At 42 months post-intervention commencement
Secondary outcome [1] 394350 0
Neurophysiological development will be assessed by EEG measures and recording of event-related potentials (ERP) on a subset of approximately 250 study children.
Timepoint [1] 394350 0
Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement
Secondary outcome [2] 394351 0
Teachers' comfort at using te reo Maori in their practice will be assessed by self-ratings.
Timepoint [2] 394351 0
Baseline, and at 9, 18, 27, 36, and 42 months post-intervention commencement
Secondary outcome [3] 394352 0
Teachers' early learning practices will be assessed by researcher-designed self-reports of shared book-reading, singing, rhyming, games, and conversational activities.
Timepoint [3] 394352 0
Baseline, and at 9, 18, 27, 36, and 42 months post-intervention commencement
Secondary outcome [4] 394353 0
The child's B4 school check data at age 4.75 will be accessed through the Ministry of Health if available. This measure rates children's school readiness on cognitive, physical, and socioemotional dimensions.
Timepoint [4] 394353 0
40-42 months post-intervention commencement
Secondary outcome [5] 394354 0
Children's Integrated Data Infrastructure (IDI) will be accessed to provide long-term data on education, health, and employment outcomes
Timepoint [5] 394354 0
5+ years post-intervention commencement
Secondary outcome [6] 395899 0
As an additional primary measure of self-regulation, we will administer the parent-report version of the Early Childhood Behaviour Questionnaire (ECBQ) in the toddler phase (ages 1.5 and 2.25 years), and the parent-report version of the Childhood Behavior Rating Scales (CBRS) in the preschool phase (ages 3, 3.75, 4.5, and 5 years).
Timepoint [6] 395899 0
Baseline, and at 9, 18, 27, 36, and 42 months post-intervention commencement
Secondary outcome [7] 395900 0
As an additional primary measure of oral language, we will administer parent-report versions of the New Zealand Communicative Development Inventories (NZ CDI short forms in English, te reo Maori, Samoan, Tongan, Mandarin, and Cantonese) in the toddler phase (ages 1.5 and 2.25 years), and the Parent Report on Oral Language and Literacy (PROLL) in the preschool phase (ages 3 to 5 years). Children's oral language in te reo Maori will be assessed in the preschool phase with parent-report checklists of phrases and sentences.
Timepoint [7] 395900 0
Baseline, and at 9, 18, 27, 36, and 42 months post-intervention commencement
Secondary outcome [8] 395902 0
As an additional primary measure of literacy, we will administer the New Zealand Word Identification Fluency test in primary school.
Timepoint [8] 395902 0
54 months post-intervention commencement
Secondary outcome [9] 395903 0
As an additional measure of children's neurophysiological development, eye-tracking measures will be administered on a subset of approximately 250 study children.
Timepoint [9] 395903 0
Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement
Secondary outcome [10] 395904 0
An age-appropriate behavioural version of a working memory task will be administered on a subset of approximately 250 study children.
Timepoint [10] 395904 0
Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement
Secondary outcome [11] 395905 0
An age-appropriate version of a behavioural inhibition task will be administered on a subset of approximately 250 study children.
Timepoint [11] 395905 0
Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement.
Secondary outcome [12] 395906 0
An age-appropriate version of a categorisation task will be administered on a subset of approximately 250 student children.
Timepoint [12] 395906 0
Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement
Secondary outcome [13] 395907 0
Teachers' skill at using te reo Maori will be assessed via vocabulary checklists modelled after the NZ Communicative Development Inventories.
Timepoint [13] 395907 0
Baseline, and at 9, 18, 27, 36, and 42 months post-intervention commencement
Secondary outcome [14] 395908 0
Parents' early learning practices will be assessed by researcher-designed self-reports of shared book-reading, singing, rhyming, games, and conversational activities.
Timepoint [14] 395908 0
Baseline, and at 9, 18, 27, 36, and 42 months post-intervention commencement
Secondary outcome [15] 397343 0
To assess children's academic progress, age-appropriate teacher ratings of children's literacy, numeracy, and key competencies will be administered..
Timepoint [15] 397343 0
18, 27, 36, 42, and 54 months post-intervention commencement
Secondary outcome [16] 397344 0
To assess children's numeracy, age-appropriate versions of number knowledge tasks will be administered.
Timepoint [16] 397344 0
At 42 and 54 months post-intervention commencement
Secondary outcome [17] 397345 0
As an additional measure of children's literacy, the DIBELS (Dynamic Indicators of Basic Early Literacy Skills) Nonsense Word Fluency task will be administered in primary school.
Timepoint [17] 397345 0
54 months post-intervention commencement
Secondary outcome [18] 397346 0
As an additional measure of children's oral language, a listening comprehension task will be administered in primary school.
Timepoint [18] 397346 0
54 months post-intervention commencement
Secondary outcome [19] 397636 0
As a behavioural measure of children's self-regulation, the Head-Toes-Knees-Shoulders task will be administered.
Timepoint [19] 397636 0
At 42 and 54 months post-intervention commencement
Secondary outcome [20] 428242 0
Advanced language (expressive and receptive) and early literacy (phonological awareness and letter recognition) will be assessed by researcher-administered Preschool Early Literacy Indicators (PELI) with children in the Brain Development and Behaviour sub-study and the Video Project sub-study.
Timepoint [20] 428242 0
18, 24, 30, 36, and 42 months post-intervention commencement for children in the Brain Development and Behaviour sub-study, and 18 and 30 months post-intervention for children in the Video Project sub-study

Eligibility
Key inclusion criteria
There will be no gender, racial/ethnic, language, or socioeconomic restrictions to
participation in this study. All children within the target age group (from 13 to 30 months at enrolment) will be exposed to the interventions within their early childhood education centre (ECEC). We are collaborating with a large national early childhood education (ECE) organisation called BestStart within which all 1,600 planned child participants, their parents, and 300 planned ECE teachers will be recruited, but data will not be collected on those children whose families have not granted consent.
Minimum age
13 Months
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with a pervasive developmental disorder or history of
brain trauma will be excluded from data analyses due to our focus on neurodevelopment outcomes.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation by early childhood centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming small to medium effect sizes, a multi-factor final measurement period ANOVA power analysis suggests a total sample size of 1600 children (400 per group, including control group) will afford the current study power between .75 and .90. The figure of 400 per group in the first phase is preferable as a target owing to the likelihood of participant dropout over the course of the study. This sample size also takes into account multiple predictor variables in possible 1-way, 4-way or 8-way ANOVA (with 4, 16, or 32 total factor levels respectively) at time of final analysis.

Statistical analyses will use multilevel modelling and moderator/mediator analyses to assess the outcomes for children's oral language and self-regulation as a function of intervention condition (nested within centres) and as a function of implementation fidelity.

We will use multiple imputation procedures to account for missing data, as long as missing data are MCAR or MAR.

The proposed factorial design will also be examined using a general Bayesian framework, specifically a Bayesian hierarchical mixed model. The aim is to maximise n (in the range of 250-400 participants per condition) and minimise artificial constraints that limit research when employing a wholly Null Hypothesis Significance Testing (NHST) approach.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/05/2021
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
5000
Accrual to date
4596
Final
Recruitment outside Australia
Country [1] 23613 0
New Zealand
State/province [1] 23613 0

Funding & Sponsors
Funding source category [1] 308399 0
Charities/Societies/Foundations
Name [1] 308399 0
Wright Family Foundation
Country [1] 308399 0
New Zealand
Funding source category [2] 308400 0
Other Collaborative groups
Name [2] 308400 0
Wellcome/LEAP
Country [2] 308400 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
Department of Psychology
93 Union Street East
Dunedin, New Zealand 9054
Country
New Zealand
Secondary sponsor category [1] 309230 0
Charities/Societies/Foundations
Name [1] 309230 0
Methodist Mission Southern
Address [1] 309230 0
44 Teviot Street
South Dunedin
Dunedin 9012
New Zealand
Country [1] 309230 0
New Zealand
Secondary sponsor category [2] 309231 0
University
Name [2] 309231 0
University of Auckland
Address [2] 309231 0
Liggins Institute
85 Park Road, Grafton
Auckland 1023
Country [2] 309231 0
New Zealand
Secondary sponsor category [3] 309232 0
University
Name [3] 309232 0
Victoria University of Wellington
Address [3] 309232 0
Kelburn
Wellington 6012
Country [3] 309232 0
New Zealand
Secondary sponsor category [4] 309236 0
Other
Name [4] 309236 0
BestStart Early Childhood Centres
Address [4] 309236 0
561 Great South Road,
Manukau,
Auckland 2104
New Zealand
Country [4] 309236 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308362 0
University of Otago Health Ethics Committee
Ethics committee address [1] 308362 0
Ethics committee country [1] 308362 0
New Zealand
Date submitted for ethics approval [1] 308362 0
09/10/2020
Approval date [1] 308362 0
23/11/2020
Ethics approval number [1] 308362 0
H20/116

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

Contacts
Principal investigator
Name 110450 0
Prof Elaine Reese
Address 110450 0
University of Otago
Department of Psychology
93 Union Street East
Dunedin, New Zealand 9054
Country 110450 0
New Zealand
Phone 110450 0
+64 03 479 8441
Fax 110450 0
64 03 479 8335
Email 110450 0
[email protected]
Contact person for public queries
Name 110451 0
Elaine Reese
Address 110451 0
University of Otago
Department of Psychology
93 Union Street East
Dunedin, New Zealand 9054
Country 110451 0
New Zealand
Phone 110451 0
+64 03 479 8441
Fax 110451 0
64 03 479 8335
Email 110451 0
[email protected]
Contact person for scientific queries
Name 110452 0
Elaine Reese
Address 110452 0
University of Otago
Department of Psychology
93 Union Street East
Dunedin, New Zealand 9054
Country 110452 0
New Zealand
Phone 110452 0
+64 03 479 8441
Fax 110452 0
64 03 479 8335
Email 110452 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
Parents have not consented to their children's data being shared.


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
EmbaseKia Ti mata Pai (Best Start): A study protocol for a cluster randomised trial with early childhood teachers to support children's oral language and self-regulation development.2023https://dx.doi.org/10.1136/bmjopen-2023-073361
EmbaseResting EEG correlates of neurodevelopment in a socioeconomically and linguistically diverse sample of toddlers: Wave 1 of the Kia Timata Pai best start New Zealand study.2024https://dx.doi.org/10.1016/j.dcn.2023.101336
N.B. These documents automatically identified may not have been verified by the study sponsor.