Children With Typical NeurodevelopmentPLAY UPNCT07355179
PLAY UP: An Intervention Program Through Active Play and Environmental Affordances
A study testing PLAY UP in people with Children With Typical Neurodevelopment, run by University of Évora at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Typical Neurodevelopment
- What is being tested?
- PLAY UP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 23 Feb 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- regular attendance in preschool; have no limitations to participate in intervention.
Who cannot join
- participating in a similar intervention program for at least 3 months; having limitations (e.g. physical limitations; intellectual neurodisorder) to take the assessment tasks;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Children With Typical Neurodevelopment
- Being tested
- PLAY UP
- Keywords
- childhood, psychomotor intervention, motor competence, socialemotional competences, executive functions, physical activity, Physically active play
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAY UPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| participant group | Experimental | 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. Receives: Behavioral: PLAY UP |
| Comparison group | No intervention | This group will maintain their regular school routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor competence
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.
Measured: 2 months
Secondary outcomes (6)
Social, Emotional, and Behavioral Competences (educator-reported)
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.
Measured: 2 months
Behavioural difficulties (parent-reported)
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.
Measured: 2 months
Executive Functioning
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.
Measured: 2 months
Spatial Activity Behaviour (SAB)
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.
Measured: 2 months
Child-Level Positional Interactions (CLPI)
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.
Measured: 2 months
Kindergarten Affordances for Physical Literacy (KAPL)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start23 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children With Typical NeurodevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Almeida, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355179
- Sponsor's protocol ID
- #24101
- Acronym
- PLAY UP
- Status last verified
- May 2026
- First submitted
- 29 Dec 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ongoing
Publications
Almeida G, Goncalves B, Luz C, Galhardas L, Bilton H, Marmeleira J. Physical Literacy through Active plaY and environmental affordances in outdoor kindergarten settings: a multidimensional approach to Unveiling Potential (PLAY UP) - study protocol for a cluster-randomised trial. BMJ Open. 2026 Jul 1;16(7):e120976. doi: 10.1136/bmjopen-2026-120976.
PubMed 42386292
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAY UP: An Intervention Program to Foster Physical Literacy Through Active Play and Environmental Affordances
- ClinicalTrials.gov ID
- NCT07355179
- Acronym / sponsor ID
- PLAY UP / #24101
- Conditions
- Children With Typical Neurodevelopment
- Keywords
- childhood, psychomotor intervention, motor competence, socialemotional competences, executive functions, physical activity, Physically active play
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participant group | Experimental | Behavioral: PLAY UPChildren 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. |
| Comparison group | No intervention | –This group will maintain their regular school routine. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- regular attendance in preschool; have no limitations to participate in intervention.
Key exclusion criteria (1 listed)
- participating in a similar intervention program for at least 3 months; having limitations (e.g. physical limitations; intellectual neurodisorder) to take the assessment tasks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAY UPThe 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. | Behavioural | participant group |
Primary outcome
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.
6 secondary outcomes
Social, Emotional, and Behavioral Competences (educator-reported)
Time frame: 2 months
Behavioural difficulties (parent-reported)
Time frame: 2 months
Executive Functioning
Time frame: 2 months
Spatial Activity Behaviour (SAB)
Time frame: 2 months
Child-Level Positional Interactions (CLPI)
Time frame: 2 months
Kindergarten Affordances for Physical Literacy (KAPL)
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 42386292Almeida G, Goncalves B, Luz C, Galhardas L, Bilton H, Marmeleira J. Physical Literacy through Active plaY and environmental affordances in outdoor kindergarten settings: a multidimensional approach to Unveiling Potential (PLAY UP) - study protocol for a cluster-randomised trial. BMJ Open. 2026 Jul 1;16(7):e120976. doi: 10.1136/bmjopen-2026-120976.
- Individual participant dataSharing planned: No. ongoing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAY UP in people with Children With Typical Neurodevelopment, run by University of Évora at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor competence (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07355179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.