Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
5 avril 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
180
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Jyväskylä, Finlande
- Niilo Mäki Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 ans à 5 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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:
-
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Control
normal early childhood education
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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School Situations Questionnaire
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Go/No-go iPad task
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Abbreviated Acceptability Rating Profile
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2021
Achèvement primaire (Réel)
31 décembre 2021
Achèvement de l'étude (Réel)
31 décembre 2021
Dates d'inscription aux études
Première soumission
26 janvier 2021
Première soumission répondant aux critères de contrôle qualité
9 février 2021
Première publication (Réel)
12 février 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 avril 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 avril 2022
Dernière vérification
1 avril 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4-C7291
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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