An interventional study of PLAY UP in Children With Typical Neurodevelopment, sponsored by University of Évora. Enrolling by invitation at 1 site in Portugal. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by University of Évora · Not applicable, Interventional, and Prevention
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Évora is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
This group will maintain their regular school routine.
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.
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.
Time frame: 2 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
Feasibility of the pilot phase
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.
Time frame: 2 months
Acceptability of the PLAY UP intervention
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.
Time frame: 2 months
Implementation quality of the PLAY UP intervention
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.
Time frame: 2 months
Plan to share: No — ongoing
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Évora