Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
5. April 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
180
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Jyväskylä, Finnland
- Niilo Mäki Institute
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
3 Jahre bis 5 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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:
-
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
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.
|
|
Kein Eingriff: Control
normal early childhood education
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
School Situations Questionnaire
Zeitfenster: Change from baseline at 1,5, 4, and 7 months
|
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
|
|
Home Situations Questionnaire
Zeitfenster: Change from baseline at 1,5, 4, and 7 months
|
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.
|
Change from baseline at 1,5, 4, and 7 months
|
|
Attention and Executive Function Rating Inventory -Preschool
Zeitfenster: 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.
|
Change from baseline at 1,5, 4, and 7 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Go/No-go iPad task
Zeitfenster: Change from baseline at 2 months
|
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
Zeitfenster: Change from baseline at 2 months
|
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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Abbreviated Acceptability Rating Profile
Zeitfenster: The questionnaire is filled at 1,5 months
|
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.
|
The questionnaire is filled at 1,5 months
|
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Abbreviated Acceptability Rating Profile
Zeitfenster: The questionnaire is filled at 4 months
|
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.
|
The questionnaire is filled at 4 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2021
Primärer Abschluss (Tatsächlich)
31. Dezember 2021
Studienabschluss (Tatsächlich)
31. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
26. Januar 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2021
Zuerst gepostet (Tatsächlich)
12. Februar 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. April 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. April 2022
Zuletzt verifiziert
1. April 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4-C7291
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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