The Best Start (Kia Tīmata Pai): A Study Protocol for a Cluster Randomized Trial with Early Childhood Teachers to Support Children’s Oral Language and Self-Regulation Development

Introduction Oral language skills are associated with children’s later self-regulation and academic skills; in turn, self-regulation in early childhood predicts successful functioning later in life. The primary objective of this study is to evaluate the separate and combined effectiveness of an oral language intervention (ENRICH) and a self-regulation intervention (ENGAGE) with early childhood teachers and parents for children’s oral language, self-regulation, and academic functioning. Methods and Analysis The Best Start study (Kia Tīmata Pai in te reo Māori, the indigenous language of New Zealand) is a cluster randomized controlled trial with teachers and children in approximately 140 early childhood centres in New Zealand. Centres are randomly assigned to receive either oral language intervention only (ENRICH), self-regulation intervention only (ENGAGE), both interventions (ENRICH + ENGAGE), or an active control condition. Teachers’ and parents’ practices and children’s oral language and self-regulation development are assessed at baseline at age 1.5 years and every 9-months to age 5, and academic performance at age 6. Teacher-child interactions will also be videotaped each year in a subset of the centres. Children’s brain and behavior development and parent-child interactions will be assessed every 6 months to age 6 years in a sub-group of volunteers. Ethics and Dissemination The Best Start trial and the two sub-studies (Video Project; Brain and Behavior Development) have been approved by the University of Otago Health Ethics Committee (H20/116), and reviewed for cultural responsiveness by: the Ngāi Tahu Research Committee (University of Otago), the Māori Advisory Group (University of Auckland, Liggins Institute) and an internal cultural advisory group. Results will be disseminated in international and national peer-reviewed academic journals and communicated to local, national, and international organizations serving early childhood teachers, parents, and young children. Trial registration This trial is registered with the Australian New Zealand Clinical Trial Registry (ANZCTR) as ACTRN12621000845831. Strengths and Limitations of This Study ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ACTRN12621000845831 ### Clinical Protocols ### Funding Statement This research is funded by a Wright Family Foundation Grant to RP. Wellcome Leap Inc. (Project Number 3724974-S001) also provided seed funding for the Brain Development and Behavior sub-study. The funders play no role in the study design, data collection, analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Health Ethics Committee of the University of Otago gave ethical approval for this work (H20/116). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes No datasets were generated or analysed during the current study protocol.