Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
2022年4月5日 更新者：Niilo Mäki Institute
The aim of this study is to examine the effectiveness of a play-based intervention designed to support the development of executive functioning in 3-5-year-old children.
The intervention is implemented in the day care setting as a part of early childhood education in collaboration with parents and local healthcare and social welfare workers.
The study hypothesizes that the intervention as an add-on to normal early childhood education brings added benefits to the development of children's executive functioning in comparison to early childhood education without the add-on.
調査の概要
詳細な説明
This cluster-randomized controlled trial examines the effectiveness of a play-based intervention, added as a component to normal early childhood education, in supporting the development of executive functioning in 3-5-year-old children in comparison to early childhood education without such a component.
12 day care centers in Finland have been randomized to intervention (n = 6) and control (n = 6) groups.
The children in the intervention group will receive the intervention in the spring of 2021, and the children in the control group will be on the wait list and receive the intervention in the fall of 2021 after measurements.
In the day care centers belonging to the intervention group, play sessions supporting the development of children's executive functioning will be arranged as a part of normal early childhood education.
The pre-selected games target children's executive functions and self-regulatory abilities, e.g.
inhibition, attention, working memory and emotion regulation.
The first phase of the intervention (6 weeks) includes play sessions for all children as well as a parents' evening.
In the second phase (8 weeks), more individualized play sessions are arranged for the children that exhibit difficulties in executive functions after the first phase.
Also, a parents' group is arranged in this phase, which will expand the daily play activities to homes.
Day care education personnel and parents fill out questionnaires concerning children's behavior at 4 time points, and the children participating in the second phase (small group activity) will complete two iPad tasks before and after the small group activity.
The study takes place in Finland.
研究の種類
介入
入学 (実際)
180
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
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Jyväskylä、フィンランド
- Niilo Mäki Institute
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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～5年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Children born between 4.6.2015 - 11.1.2018
- For the second phase (small group activity): children must exhibit problems in executive functions (e.g. inattention, hyperactivity, impulsivity) and be considered as potentially benefitting from additional practice as assessed by early childhood educators
Exclusion Criteria:
-
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：防止
- 割り当て：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 |
|---|---|
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実験的：Intervention
play sessions included as a part of normal early childhood education; parents' evening for all parents; parents' group for the parents of children that have difficulties in self-regulation and that are offered more individualized small group activity
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Early childhood education workers play games with children during day care.
The games (e.g.
ball games, puzzles, Simon says) target children's executive functions and self-regulatory skills, e.g.
inhibition, attention, and emotion regulation.
The first phase of the intervention (6 weeks) includes play sessions (15 minutes each day) for all children as well as a parents' evening to encourage playing at home.
In the second phase (8 weeks), more individualized small group play sessions (3 times a week, 30 minutes at once) are arranged for the children that show difficulties in self-regulation after the first phase.
Also, a parents' group including 6 group sessions and 2 phone calls is arranged for their parents in this phase.
The participating parents are asked to play the games for 20 minutes each day with their children.
During the group meetings, the parents share their experiences of playing at home and receive support and guidance from 2 health care professionals.
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介入なし：Control
normal early childhood education
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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School Situations Questionnaire
時間枠：Change from baseline at 1,5, 4, and 7 months
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Early childhood education workers assess whether children exhibit problem behaviors in different preschool situations and the severity of the problems.
Possible values range between 0 and 9. Higher values mean more severe problems.
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Change from baseline at 1,5, 4, and 7 months
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Home Situations Questionnaire
時間枠：Change from baseline at 1,5, 4, and 7 months
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Parents assess whether children exhibit problem behaviors in different home situations and the severity of the problems.
Possible values range between 0 and 9. Higher values mean more severe problems.This measurement concerns the children who take part in the first phase of the intervention.
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Change from baseline at 1,5, 4, and 7 months
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Attention and Executive Function Rating Inventory -Preschool
時間枠：Change from baseline at 1,5, 4, and 7 months
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Early childhood education workers assess the extent to which children have problems on different areas of executive functioning (e.g.
distractibility, directing and sustaining attention, planning).
Possible values range between 0 and 3. Higher values mean more severe problems.
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Change from baseline at 1,5, 4, and 7 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Go/No-go iPad task
時間枠：Change from baseline at 2 months
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A game-like task measuring response inhibition from the Early Years Toolbox.
In the task, children are supposed to catch the fish and avoid the sharks.
This measurement concerns children selected for the second phase of the intervention due to exhibiting difficulties in self-regulation.
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Change from baseline at 2 months
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Working memory iPad task
時間枠：Change from baseline at 2 months
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A game-like task ("Mr.
Ant") from the Early Years Toolbox.
In the task, children are supposed to remember the locations of stickers placed on an ant character.
This measurement concerns children selected for the second phase of the intervention due to exhibiting difficulties in self-regulation.
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Change from baseline at 2 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Abbreviated Acceptability Rating Profile
時間枠：The questionnaire is filled at 1,5 months
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Intervention providers and parents assess the acceptability of the intervention after the first phase of the intervention.
Possible values range between 1 and 6.
Higher values mean greater acceptability.
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The questionnaire is filled at 1,5 months
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Abbreviated Acceptability Rating Profile
時間枠：The questionnaire is filled at 4 months
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Intervention providers and parents assess the acceptability of the intervention after the second phase of the intervention.
Possible values range between 1 and 6.
Higher values mean greater acceptability.
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The questionnaire is filled at 4 months
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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。
スポンサー
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 (実際)
2021年1月1日
一次修了 (実際)
2021年12月31日
研究の完了 (実際)
2021年12月31日
試験登録日
最初に提出
2021年1月26日
QC基準を満たした最初の提出物
2021年2月9日
最初の投稿 (実際)
2021年2月12日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月6日
QC基準を満たした最後の更新が送信されました
2022年4月5日
最終確認日
2022年4月1日
詳しくは
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