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Play and Pre-Literacy Among Young Children (PLAY)

2017年3月21日 更新者:John Cairney、McMaster University
Children begin to develop fundamental motor skills (FMS), such as running and kicking, and pre-literacy skills, such as rhyming, during early childhood. These skills are very important as they lay the foundation for more complex movements and literacy skill development later in life, support overall healthy development in several areas, and help contribute to the child's readiness for school. A child with strong motor skills is well equipped to lead a life with healthy levels of physical activity, positive social interactions, positive self-perceptions, and greater cognitive and language abilities. These skills will not develop optimally on their own so it is essential to teach, challenge, and reinforce them at an early age; often this learning takes place at home prior to entering school. Most research on this topic has primarily focused on school-aged children or children with specific developmental challenges and less is known about teaching motor and pre-literacy skills to young children and giving parents the tools to practice these skills at home with their children. The aim of the present study is to examine the effect of a motor and pre-literacy program, which emphasizes parental involvement, on motor, pre-literacy, social skills, cognitive abilities, and self-competence in 3 to 4 year old children with typical development.

調査の概要

詳細な説明

The primary purpose of the intervention is to support the overall healthy development of children. Children will be recruited from families attending community agencies (e.g. Ontario Early Years Centres) in Hamilton. Interested parents will receive information flyers with the study team's contact information and instructions to contact the study team if they are interested in participating in the study. Interested parents will be screened for eligibility of their child. Information packages will be emailed or mailed to eligible families and will be followed-up with over the telephone in one week to obtain informed verbal consent. Baseline appointments will be booked for all eligible children. Informed written consent will be obtained at the baseline appointment before testing begins. Children will be randomized 1:1 to either the experimental or wait-list control group. Randomization will be completed using a computer algorithm. All children will be assessed pre- and post-program as well as at follow-up, 5 weeks after the completion of the program. Children in the wait-list control group will be assessed one additional time at baseline. The program will run for one hour per week for 10 consecutive weeks. Parents will be asked to complete a checklist each week indicating the number of times they practiced the activities at home. A sample size of 36 children is considered sufficient to provide 80% power to detect a medium effect size, with an alpha of 0.05. Eighteen children will be randomized to the experimental group and 18 children will be randomized to the wait-list control group.

研究の種類

介入

入学 (実際)

53

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Hamilton、Ontario、カナダ、L8H 4L8
        • Boys and Girls Club of Hamilton
      • Hamilton、Ontario、カナダ、L8P 0A1
        • McMaster Innovation Park

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

3年~4年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • typical development

Exclusion Criteria:

  • diagnosed with any developmental delay (e.g., autism, Developmental Coordination Disorder, etc.) or health conditions that may prohibit safe participation in the program (e.g., unstable heart condition).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Motor and pre-literacy program
First group to receive the motor and pre-literacy program.
The program will run for 60 minutes once per week for 10 consecutive weeks and will consist of three components: direct FMS instruction, unstructured exploratory free-play, and an interactive storybook reading activity. The curriculum and teaching strategies to be used for the first two segments of our intervention have been successfully implemented in previous research to improve the motor skills of 4 year old children with autism (Bremer, Balogh, & Lloyd, 2014). Specific strategies and books were selected from an existing evidence-based curriculum (Justice & McGuinty, 2009). There will be active involvement of at least one parent in the direct instruction and reading components.
アクティブコンパレータ:Wait-list comparison
Second group to receive the motor and pre-literacy program after the experimental arm has completed the program.
The participants will not participate in the motor and pre-literacy program for 10 weeks after enrollment and will continue with their normal daily life without any intervention. After the experimental arm completes the motor and pre-literacy program, the wait-list group will receive the exact same motor and pre-literacy intervention.

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks
時間枠:Baseline and 11-12 weeks
Baseline and 11-12 weeks
Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 11-12 weeks
時間枠:Baseline and 11-12 weeks
Baseline and 11-12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks
時間枠:Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Peabody Developmental Motor Scales-2 at 15-16 weeks
時間枠:Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 15-16 weeks
時間枠:Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 11-12 weeks
時間枠:Baseline and 11-12 weeks.
Baseline and 11-12 weeks.
Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 15-16 weeks
時間枠:Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 15-16 weeks
時間枠:Baseline and 15-16 weeks.
Parent-reported measure of executive function
Baseline and 15-16 weeks.
Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 11-12 weeks
時間枠:Baseline and 11-12 weeks.
Parent-reported measure of executive function
Baseline and 11-12 weeks.
Change from baseline in Social Skills Improvement System (parent version) scale at 15-16 weeks
時間枠:Baseline and 15-16 weeks.
Parent-reported measure of social skills and behavioral problems
Baseline and 15-16 weeks.
Change from baseline in Social Skills Improvement System (parent version) scale at 11-12 weeks
時間枠:Baseline and 11-12 weeks.
Parent-reported measure of social skills and behavioral problems
Baseline and 11-12 weeks.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年6月1日

一次修了 (実際)

2016年8月1日

研究の完了 (実際)

2016年8月1日

試験登録日

最初に提出

2015年4月24日

QC基準を満たした最初の提出物

2015年4月28日

最初の投稿 (見積もり)

2015年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2017年3月22日

QC基準を満たした最後の更新が送信されました

2017年3月21日

最終確認日

2017年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • INCH-0415

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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