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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Portugal
    • Évora District
      • Evora, Évora District, Portugal, 7000
        • Gabriela Almeida

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: PLAY UP
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.
No Intervention: Comparison group
This group will maintain their regular school routine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
2 months
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.
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
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.
2 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
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.
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Évora

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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