- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07355179
PLAY UP: An Intervention Program Through Active Play and Environmental Affordances (PLAY UP)
May 13, 2026 updated by: Gabriela Almeida, University of Évora
PLAY UP: An Intervention Program to Foster Physical Literacy Through Active Play and Environmental Affordances
The goal of this cluster-randomized trial is to investigate how a co-created, affordance-based approach - developed in collaboration with children - and combined with educator training, can support preschool children's engagement in active play and their holistic development.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Évora District
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Evora, Évora District, Portugal, 7000
- Gabriela Almeida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- regular attendance in preschool; have no limitations to participate in intervention.
Exclusion Criteria:
- participating in a similar intervention program for at least 3 months; having limitations (e.g. physical limitations; intellectual neurodisorder) to take the assessment tasks;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: participant group
Children in the experimental group will receive a 15-session intervention.
Intervention will be implemented in the outdoors of the kindergarten, by a psychomotor therapist and children's educator.
Sessions will involve active play and will prioritize, strengthen and expand opportunities for children to engage with their surroundings.
|
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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No Intervention: Comparison group
This group will maintain their regular school routine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor competence
Time Frame: 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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social, Emotional, and Behavioral Competences (educator-reported)
Time Frame: 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.
|
2 months
|
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Behavioural difficulties (parent-reported)
Time Frame: 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
Time Frame: 2 months
|
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
|
|
Spatial Activity Behaviour (SAB)
Time Frame: 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.
|
2 months
|
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Child-Level Positional Interactions (CLPI)
Time Frame: 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)
Time Frame: 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.
|
2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation quality of the PLAY UP intervention
Time Frame: 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.
|
2 months
|
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Acceptability of the PLAY UP intervention
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
December 29, 2025
First Submitted That Met QC Criteria
January 12, 2026
First Posted (Actual)
January 21, 2026
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #24101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
ongoing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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