- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07355179
SPILL MER: Et intervensjonsprogram gjennom aktiv lek og omgivelsenes muligheter (PLAY UP)
13. mai 2026 oppdatert av: Gabriela Almeida, University of Évora
SPILL VIDERE: Et intervensjonsprogram for å fremme fysisk kompetanse gjennom aktivt lek og miljømessige muligheter
Målet med denne klyngerandomiserte studien er å undersøke hvordan en medskapt, mulighetsbasert tilnærming - utviklet i samarbeid med barn - og kombinert med pedagogopplæring, kan støtte førskolebarns engasjement i aktiv lek og deres helhetlige utvikling.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Évora District
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Evora, Évora District, Portugal, 7000
- Gabriela Almeida
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
Inkluderingskriterier:
- regelmessig oppmøte i barnehage; har ingen begrensninger for å delta i intervensjonen.
Ekskluderingskriterier:
- deltar i et lignende intervensjonsprogram i minst 3 måneder; har begrensninger (f.eks. fysiske begrensninger; intellektuell nevroforstyrrelse) til å utføre vurderingsoppgavene;
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: deltakergruppe
Barn i eksperimentgruppen vil motta en 15-sesjons intervensjon.
Intervensjonen vil bli gjennomført utendørs i barnehagen, av en psykomotorisk terapeut og barnehagelærer.
Sesjonene vil involvere aktiv lek og vil prioritere, styrke og utvide mulighetene for barn til å engasjere seg med omgivelsene sine.
|
The PLAY UP intervention comprises 15 outdoor sessions (60 minutes each), delivered twice weekly by a psychomotor therapy professional, with the classroom educator providing pedagogical support.
Sessions adopt a co-creation approach, actively engaging children in shaping play experiences while leveraging environmental affordances that promote movement and social interaction.
Each PLAY UP session follows a structure, beginning with a warm-up (experimentation time) that allows children to move freely and explore environmental affordances through active play.
The main section combines guided reflection, child-led activity choices, and collective movement exploration, with adults facilitating engagement and expanding play possibilities.
Sessions conclude with a symbolization and meaning-making phase, supporting reflection on experiences and promoting meaningful learning.
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Ingen inngripen: Sammenligningsgruppe
Denne gruppen vil opprettholde sin vanlige skolerutine.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor competence
Tidsramme: 2 months
|
Motor competence, as an indicator of physical literacy, will be assessed using the Movement Assessment Battery for Children - Second Edition (MABC-2; age band 1).
Movement ABC consists of 3 subtests that measure three different areas: manual dexterity; aiming and catching; and balance.
Raw scores obtained in each task are converted into age-standardized scores according to the norms provided in the MABC-2 manual.
The MABC-2 total standardized score is derived from the manual dexterity, aiming and catching, and balance domains.
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2 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Social, Emotional, and Behavioral Competences (educator-reported)
Tidsramme: 2 months
|
Preschool and Kindergarten Behaviour Scale (PKBS), completed by preschool educators, evaluates children's social-emotional skills and behavior problems during free play with their peers.
The instrument is organized into two main scales: (i) the Social Skills Scale divided into three dimensions - Social Cooperation, Social Interaction, and Social Independence; and (ii) the Problem Behavior Scale divided into two subscales - Externalizing Behavior Problems and Internalizing Behavior Problems.
The PKBS Social Skills Scale score and Problem Behaviour Scale score will be used.
Higher scores on the Social Skills Scale indicate stronger social-emotional competence, whereas higher scores on the Problem Behaviour Scale indicate greater behavioural concerns.
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2 months
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Behavioural difficulties (parent-reported)
Tidsramme: 2 months
|
Children's behavioural difficulties will be assessed using the Strengths and Difficulties Questionnaire (SDQ; ages 4-17 years), a 25-item psychosocial questionnaire completed by parents, designed to assess children's strengths and difficulties, providing behavioural indicators of potential mental health problems.
The SDQ total difficulties score will be derived from the sum of the four problem subscales - Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Relationship Problems - and interpreted according to predefined cutoffs as normal, borderline, or clinically significant.
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2 months
|
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Executive Functioning
Tidsramme: 2 months
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Key executive functions inhibitory control, cognitive flexibility, and working memory will be assessed using the Head-Toes-Knees-Shoulders (HTKS) task.
Task performance also relies on the child's sustained attention.
The total HTKS score will be used as a single composite score reflecting executive functioning, including inhibitory control, cognitive flexibility, working memory, and sustained attention.
A higher score reflects a better executive functioning.
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2 months
|
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Spatial Activity Behaviour (SAB)
Tidsramme: 2 months
|
Spatial Activity Behaviour (SAB) will be assessed as the spatial distribution of physical activity intensity during outdoor recess.
This outcome will be derived from synchronised accelerometry and Global Positioning System (GPS) data.
The reported value will describe where different physical activity intensities occur within the kindergarten outdoor environment.
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2 months
|
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Child-Level Positional Interactions (CLPI)
Tidsramme: 2 months
|
Child-Level Positional Interactions (CLPI) will be assessed using real-time spatial positioning tracked over approximately 30 minutes during outdoor recess using high-resolution sensor technology.
This will allow the capture of detailed movement trajectories and interpersonal positioning in the playground environment.
Outcomes will include mean inter-child distance and frequency of proximity interactions during recess.
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2 months
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Kindergarten Affordances for Physical Literacy (KAPL)
Tidsramme: 2 months
|
Kindergarten affordances for physical literacy (KAPL) will be assessed using the GO-Exterior instrument and Photo Elicitation Interviews.
The GO-Exterior instrument includes a structured observation grid of the outdoor environment and a semi-structured interview with the educator, allowing the calculation of category-specific and overall scores related to outdoor environmental quality, action opportunities, adult role, and routines.
Photo Elicitation Interviews will be conducted with children to explore their enjoyable experiences, appreciation, connection to the environment, preferences, perceived physical and social affordances, and experiences related to movement, play, and physical activity.
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2 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Implementation quality of the PLAY UP intervention
Tidsramme: 2 months
|
Implementation quality will be assessed by examining intervention dose, intensity, duration, fidelity to planned procedures, resources required, barriers and facilitators to implementation, and safety, including monitoring and reporting of adverse events.
Data will be collected through research team records, observation logs, and educator feedback.
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2 months
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Acceptability of the PLAY UP intervention
Tidsramme: 2 months
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Acceptability will be assessed from the perspectives of children, educators, and the research team.
Indicators will include children's engagement, participation, and perceived enjoyment, as well as educators' and researchers' perceptions of the suitability and acceptability of the intervention.
Data will be collected through observational records and semi-structured interviews with educators and children.
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2 months
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Feasibility of the pilot phase
Tidsramme: 2 months
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Feasibility will be assessed using recruitment, retention, participation, attendance, and adherence rates, as well as the feasibility of assessment procedures and intervention delivery.
Indicators will include the number/proportion of eligible children recruited, intervention sessions delivered as planned, and children attending/participating in the intervention sessions.
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2 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. februar 2026
Primær fullføring (Antatt)
30. juni 2026
Studiet fullført (Antatt)
30. juni 2027
Datoer for studieregistrering
Først innsendt
29. desember 2025
Først innsendt som oppfylte QC-kriteriene
12. januar 2026
Først lagt ut (Faktiske)
21. januar 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- #24101
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