Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
5 april 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
180
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Jyväskylä, Finland
- Niilo Mäki Institute
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
3 jaar tot 5 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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:
-
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Geen tussenkomst: Control
normal early childhood education
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
School Situations Questionnaire
Tijdsspanne: 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.
|
Change from baseline at 1,5, 4, and 7 months
|
|
Home Situations Questionnaire
Tijdsspanne: 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
Tijdsspanne: Change from baseline at 1,5, 4, and 7 months
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Go/No-go iPad task
Tijdsspanne: 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.
|
Change from baseline at 2 months
|
|
Working memory iPad task
Tijdsspanne: 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.
|
Change from baseline at 2 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Abbreviated Acceptability Rating Profile
Tijdsspanne: 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
|
|
Abbreviated Acceptability Rating Profile
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2021
Primaire voltooiing (Werkelijk)
31 december 2021
Studie voltooiing (Werkelijk)
31 december 2021
Studieregistratiedata
Eerst ingediend
26 januari 2021
Eerst ingediend dat voldeed aan de QC-criteria
9 februari 2021
Eerst geplaatst (Werkelijk)
12 februari 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 april 2022
Laatste update ingediend die voldeed aan QC-criteria
5 april 2022
Laatst geverifieerd
1 april 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 4-C7291
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .