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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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5 July 2021 |
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Main ID: |
ACTRN12621000845831 |
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Date of registration:
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01/07/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Best Start: The effect of teacher-child interactions on young children's oral language and self-regulation
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Scientific title:
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The Best Start: A cluster randomised controlled trial on the effect of teacher-child interactions in early childhood centres for young children's oral language and self-regulation |
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Date of first enrolment:
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04/05/2021 |
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Target sample size:
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3500 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12621000845831.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Factorial;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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New Zealand
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Contacts
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Name:
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Prof Elaine Reese
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Address:
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University of Otago
Department of Psychology
93 Union Street East
Dunedin, New Zealand 9054
New Zealand |
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Telephone:
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+64 03 479 8441 |
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Email:
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elaine.reese@otago.ac.nz |
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Affiliation:
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Name:
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Prof Elaine Reese
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Address:
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University of Otago
Department of Psychology
93 Union Street East
Dunedin, New Zealand 9054
New Zealand |
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Telephone:
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+64 03 479 8441 |
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Email:
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elaine.reese@otago.ac.nz |
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Affiliation:
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Key inclusion & exclusion criteria
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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 15 to 24 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 and 300 planned ECE teachers will be recruited, but data will not be collected on those children whose families have not granted consent.
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.
Age minimum:
15 Months
Age maximum:
75 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Mental Health - Studies of normal psychology, cognitive function and behaviour
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Self-regulation;Oral language; Self-regulation Oral language
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Intervention(s)
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The aim of this project is to conduct a cluster randomised controlled trial (RCT) to evaluate two evidence-based programmes — ENRICH (Enhancing Rich Interactions) 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 18 months and follow them to age 6. 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 a curriculum-as-usual control group.
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) Control: Curriculum as usual + child development webinars
ENRICH and ENGAGE will be delivered using a "train the trainer" model in which investigators and trained intervention providers with at least 10 years of experience in early childhood education will train educational practice leaders in the BestStart early childhood organisation in small face-to-face workshops. Educational 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 gam
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Primary Outcome(s)
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Advanced language (expressive and receptive) and early literacy (phonological awareness and letter recognition) will be assessed by the Preschool Early Literacy Indicators (PELI). [At 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Oral language will be assessed by age-appropriate teacher-report versions of the New Zealand Communicative Development Inventories (NZ CDI short forms).[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Self-regulation will be assessed through age-appropriate teacher-report versions of the Child Behavior Questionnaire (CBQ).[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Secondary Outcome(s)
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An age-appropriate behavioural version of a working memory task will be administered on a subset of approximately 250 study children.[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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An age-appropriate version of a behavioural inhibition task will be administered on a subset of approximately 250 study children. [Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement.]
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An age-appropriate version of a categorisation task will be administered on a subset of approximately 250 student children. [Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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As a behavioural measure of children's self-regulation, the Head-Toes-Knees-Shoulders task will be administered. [18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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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. [54 months post-intervention commencement]
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As an additional measure of children's neurophysiological development, eye-tracking measures will be administered on a subset of approximately 250 study children.[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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As an additional measure of children's oral language, a listening comprehension task will be administered in primary school. [54 months post-intervention commencement]
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As an additional primary measure of literacy, we will administer the New Zealand Word Identification Fluency test in primary school.[54 months post-intervention commencement]
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As an additional primary measure of oral language, we will administer age-appropriate parent-report versions of the New Zealand Communicative Development Inventories (CDI).[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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As an additional primary measure of self-regulation, we will administer parent-report versions of the Behavioral Assessment Scale (BASC-3).[6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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As an additional primary measure of self-regulation, we will administer parent-report versions of the Children's Behavior Questionnaire (CBQ).[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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As an additional primary measure of self-regulation, we will administer teacher-report versions of the Behavioral Assessment Scale for Children - 3 (BASC-3).[6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Children's Integrated Data Infrastructure (IDI) will be accessed to provide long-term data on education, health, and employment outcomes[5+ years post-intervention commencement]
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Neurophysiological development will be assessed by EEG measures and recording of event-related potentials (ERP) on a subset of approximately 250 study children.[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Parents' early learning practices will be assessed by researcher-designed self-reports of shared book-reading, singing, rhyming, games, and conversational activities.[Baseline, and at 6, 12, 18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Teachers' comfort at using te reo Maori in their practice will be assessed by self-ratings.[Baseline, and at 6, 12, 18, 24, 30, 36, 42 months post-intervention commencement]
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Teachers' early learning practices will be assessed by researcher-designed self-reports of shared book-reading, singing, rhyming, games, and conversational activities.[Baseline, and at 6, 12, 18, 24, 30, 36, 42 months post-intervention commencement]
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Teachers' skill at using te reo Maori will be assessed via vocabulary checklists modelled after the NZ Communicative Development Inventories.[Baseline, and at 6, 12, 18, 24, 30, 36, and 42 months post-intervention commencement]
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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.[40-42 months post-intervention commencement]
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To assess children's academic progress, age-appropriate teacher ratings of children's literacy, numeracy, and key competencies will be administered.. [18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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To assess children's numeracy, age-appropriate versions of number knowledge tasks will be administered. [18, 24, 30, 36, 42, and 54 months post-intervention commencement]
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Source(s) of Monetary Support
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Wellcome/LEAP
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Wright Family Foundation
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Ethics review
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Status: Approved
Approval date: 23/11/2020
Contact:
University of Otago Health Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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